Audiovisual Aid Pilot Study

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT02506673
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.5
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Little is known about perioperative stress responses and possible anxiety mitigating factors like audiovisual aids or IV sedation. Most studies use surrogate markers and retrospective questionnaires, and are not based on real-time gathered data. Skin conductance measurements allow the sympathetic discharge to be evaluated down to fractions of a second and enable us to continuously monitor stress responses as skin conductance responses/per second during the perioperative management. In our study, the investigators propose to examine the effect of personal audiovisual equipment (audio/video goggles) on perioperative stress, pain, and overall experience in patients undergoing ambulatory meniscectomy under spinal anesthesia. Patients will be randomly assigned to either receive traditional sedation or light sedation in addition to audiovisual equipment. The investigators hope to determine outcome estimates of the use of this equipment on stress levels using skin conductance measurements, request for further sedation, postoperative pain levels and analgesic consumption, time to discharge readiness, and overall patient satisfaction, and collect thus far unavailable data on the stress response to perioperative stresses (such as IV insertion and spinal placement) in order to allow for power analyses for future studies.

Condition or Disease	Intervention/Treatment	Phase
Stress, Psychological	Device: Zeiss, Cinema ProMED (audiovisual equipment); Drug: Midazolam; Device: Skin Conductance Monitor	N/A

Detailed Description

PLEASE NOTE: After conducting the interim analysis and plotting the skin conductance data, we have determined that the graphs are not consistent enough to draw any conclusions. Given the technical difficulties we have encountered with the Med-Storm Stress Detector, as well as the labor intensity associated with it, we have decided that we will no longer use it from patient 14 on. We will not mark the time points and hand movements described in the protocol, as this data was used to understand the skin conductance data. We will continue to enroll patients to complete this pilot/exploratory study, as the other secondary outcomes--in particular, the surveys--could provide valuable information.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Audiovisual Aids on Perioperative Stress Response, Pain and Overall Experience - a Randomized Controlled Pilot Study
• Actual Study Start Date: Jan 14, 2016
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sedation only with skin conductance monitor Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge.	Drug: Midazolam; Device: Skin Conductance Monitor
Experimental: Sedation & audiovisual aids with skin conductance monitor Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge.	Device: Zeiss, Cinema ProMED (audiovisual equipment); Drug: Midazolam; Device: Skin Conductance Monitor

Outcome Measures

Primary Outcome Measures

1. Skin Conductance Response [Measured in 5 minute intervals, from holding area until PACU discharge.]

   Primary outcome will be number of skin conductance responses per second (SCR/sec) and amplitude of skin conductance responses averaged over time in 5 minute intervals and at key time points such before, during and after insertion of an IV, discussion with surgeon, anesthesiologist, immediately before leaving the holding area, immediately after entering the OR, during application of monitors, before and after administration of sedatives, before, during and after spinal insertion, incision, immediately prior to leaving the OR, after arrival at PACU and monitors are placed, before discharge from the PACU.

Secondary Outcome Measures

1. Beats Per Minute (BPM) [Measured from preop to postop]

   The change in heart rate from holding area until PACU discharge.

2. Systolic and Diastolic Blood Pressure [Measured from preop to postop]

   The maximum change in postoperative systolic and diastolic blood pressure from holding area until PACU discharge.

3. Respiratory Rate [Measured from preop to postop]

   The maxmimum change in postoperative respiratory rate from holding area until PACU discharge.

4. Number of Patients Who Requested Additional Sedation [In the operating room]

   Number of patients who requested additional sedative medication in the operating room.

5. Pain Numerical Rating Scale (NRS) Levels [Holding area, Postop (PACU, 30 minutes after arrival to PACU and POD1)]

   Pain scores at rest will be collected from patients using the numerical rating scale (NRS), which asks patients to report their level of pain on a scale from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. NRS levels in holding area, PACU until discharge from the PACU and one day after surgery, postop day 1.

6. Narcotic Consumption [Preop until 24 hours after surgery (holding area until POD 1)]

   Narcotic consumption "intraop", "postop" and "POD1"

7. State-Trait Anxiety Inventory Questionnaire (STAI) [holding area and PACU]

   Questionnaire to measure state anixety levels based on a 4-point likert scale and consists of 40 questions. The questionnaire measures two types of anxiety: state anxiety and trait anxiety. State anxiety relates to anxiety about an event, while trait anxiety in anxiety level as a personal characteristic. Scores can range from 20 to 80 and higher scores correlate with more anxiety.

8. Heidelberg Peri-anaesthetic Questionnaire [At PACU upon spinal resolution.]

   The questionnaire consists of 38 questions assessing perioperative satisfaction about five identified themes: trust and atmosphere; fear; discomfort; treatment by personnel; and information and waiting. The questions are rated on a 4-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Higher scores indicate higher levels of satisfaction. Patient satisfaction (Heidelberg Peri-Anaesthetic Questionnaire) in PACU upon spinal resolution.

9. Client Satisfaction Questionnaire (CSQ-8) [PACU upon spinal resolution]

   The client satisfaction questionnaire (CSQ-8) is a standardized satisfaction measure and was used to collect patient feedback on the audio visual devices. Response options differ, but all are on a 4-point scale. Scores range from 8 to 32, with higher values indicating higher satisfaction. Patient feedback (CSQ8) in PACU upon spinal resolution provider feedback (form sent to providers at end of surgery day)

10. Number of Providers That Were Satisfied With Their Experience With the Audio-visual Aids [Sent to providers at end of surgery.]

    Anesthesia providers were asked to provide feedback on their experience with the audio-visual aids when the randomization was for the use of the device. This was collected upon surgery end.

11. Request of Sedation/Termination of AVA [From consent until spinal resolution (avg 6 hs)]

    Request of Sedation/Termination of AVA (After consent has been obtained until spinal resolution in the recovery room, average of 6 hours)

12. Number of Participants With Complications [Intraoperatively and in the recovery room, average of 3 hours]

    The percentage of patients who experienced complications (headache, transient neurologic symptoms, nausea and vomiting, ...)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients scheduled for primary, ambulatory, arthroscopic meniscectomy under spinal anesthesia

Exclusion Criteria:

• Patients with psychiatric disease and those on antidepressants

• Contraindications to spinal anesthesia or allergy to study medication

• Age < 18 years

• Patients with audiovisual impairments

• Patients with inability to communicate in English or understand the study requirements

• Chronic pain patients +/- opioid use

• Patients with (neuro)dermatoses encompassing the hand

• Patients with pacemakers

• Patients with diabetes or known neuropathic disease

• Patients with a history of epilepsy or seizure disorder

• Patients with a history of claustrophobia

• Patients with a history of epilepsy

• Patients with prior history of epilepsy or seizure disorder

• Patients undergoing a revision or open procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery (HSS)	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

• Principal Investigator: Stavros G. Memtsoudis, MD, PhD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 18, 2019

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT02506673
• Other Study ID Numbers: 2014-394
• First Posted: Jul 23, 2015
• Last Update Posted: Feb 10, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Hospital for Special Surgery, New York: Audiovisual Aids; Perioperative Period; Anxiety
• Additional relevant MeSH terms: Stress, Psychological; Midazolam

Study Results

Participant Flow

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Period Title: Overall Study
STARTED	13	13
COMPLETED	13	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor	Total
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor	Total of all reporting groups
Overall Participants	13	13	26
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 76.9%	13 100%	23 88.5%
>=65 years	3 23.1%	0 0%	3 11.5%
Sex: Female, Male (Count of Participants)
Female	3 23.1%	0 0%	3 11.5%
Male	10 76.9%	13 100%	23 88.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 7.7%	1 7.7%	2 7.7%
Not Hispanic or Latino	11 84.6%	12 92.3%	23 88.5%
Unknown or Not Reported	1 7.7%	0 0%	1 3.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 7.7%	1 7.7%	2 7.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 7.7%	0 0%	1 3.8%
White	9 69.2%	11 84.6%	20 76.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 15.4%	1 7.7%	3 11.5%
Region of Enrollment (participants) [Number]
United States	13 100%	13 100%	26 100%

Outcome Measures

1. Primary Outcome

Title	Skin Conductance Response
Description	Primary outcome will be number of skin conductance responses per second (SCR/sec) and amplitude of skin conductance responses averaged over time in 5 minute intervals and at key time points such before, during and after insertion of an IV, discussion with surgeon, anesthesiologist, immediately before leaving the holding area, immediately after entering the OR, during application of monitors, before and after administration of sedatives, before, during and after spinal insertion, incision, immediately prior to leaving the OR, after arrival at PACU and monitors are placed, before discharge from the PACU.
Time Frame	Measured in 5 minute intervals, from holding area until PACU discharge.

Outcome Measure Data

Analysis Population Description

We had planned to use the Med-Storm Stress detector to measure skin conductance throughout the procedure until discharge. However, due to repeated technical difficulties with the device and inconclusive data from an analysis of a small number of patients data collection was stopped. No data are presented here.

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Measure Participants	13	13
Mean (Standard Deviation) [skin conductance responses per second]	NA (NA)	NA (NA)

2. Secondary Outcome

Title	Beats Per Minute (BPM)
Description	The change in heart rate from holding area until PACU discharge.
Time Frame	Measured from preop to postop

Outcome Measure Data

Analysis Population Description

Baseline has the heart rate number but analysis for intraop and postop is the change of the variable. Some patients were discharge earlier

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Measure Participants	13	13
BPM Baseline	71.7 (10.2)	66.8 (8.7)
BPM change Intraop	17 (27)	17 (11)
BPM change Postop	2 (10)	-6 (14)

3. Secondary Outcome

Title	Systolic and Diastolic Blood Pressure
Description	The maximum change in postoperative systolic and diastolic blood pressure from holding area until PACU discharge.
Time Frame	Measured from preop to postop

Outcome Measure Data

Analysis Population Description

Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for baseline, intra op and post op was recorded.

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Measure Participants	013	013
DBP Baseline	82.8 (12.7)	79.6 (9.5)
DBP change intraop	3 (8)	2 (7)
DBP change postop	-2 (11)	-4 (6)
SBP Baseline	135.3 (14.5)	129.2 (15.1)
SBP change intraop	7 (10)	7 (14)
SBP change postop	-8 (13)	-2 (15)

4. Secondary Outcome

Title	Respiratory Rate
Description	The maxmimum change in postoperative respiratory rate from holding area until PACU discharge.
Time Frame	Measured from preop to postop

Outcome Measure Data

Analysis Population Description

Some data was not available for all participants due to equipment not working or due to early discharge

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Measure Participants	013	013
RR Baseline	17.2 (2.2)	16.9 (1.7)
RR change intraop	5 (12)	4 (4)
RR change postop	-1 (3)	1 (5)

5. Secondary Outcome

Title	Number of Patients Who Requested Additional Sedation
Description	Number of patients who requested additional sedative medication in the operating room.
Time Frame	In the operating room

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Measure Participants	13	13
Count of Participants [Participants]	5 38.5%	3 23.1%

6. Secondary Outcome

Title	Pain Numerical Rating Scale (NRS) Levels
Description	Pain scores at rest will be collected from patients using the numerical rating scale (NRS), which asks patients to report their level of pain on a scale from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. NRS levels in holding area, PACU until discharge from the PACU and one day after surgery, postop day 1.
Time Frame	Holding area, Postop (PACU, 30 minutes after arrival to PACU and POD1)

Outcome Measure Data

Analysis Population Description

Holding area, PACU arrival, 30 minutes after arrival to PACU and POD1.

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Measure Participants	013	013
Holding area	1.9 (1.6)	2.2 (1.4)
PACU arrival	0 (0)	0 (0)
30 minutes after arrival to PACU	0.6 (2.2)	0 (0)
POD1	2.5 (1.7)	2.1 (1.5)

7. Secondary Outcome

Title	Narcotic Consumption
Description	Narcotic consumption "intraop", "postop" and "POD1"
Time Frame	Preop until 24 hours after surgery (holding area until POD 1)

Outcome Measure Data

Analysis Population Description

POD1 - 13 patients from the AVA group were analyzed due to early discharge.

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Measure Participants	13	13
OME mg Intraop	2.3 (8.3)	3.5 (12.5)
OME mg Inpatient postop	9.8 (6)	10.8 (5)
OME mg POD1	11.0 (9.9)	11.5 (12.3)

8. Secondary Outcome

Title	State-Trait Anxiety Inventory Questionnaire (STAI)
Description	Questionnaire to measure state anixety levels based on a 4-point likert scale and consists of 40 questions. The questionnaire measures two types of anxiety: state anxiety and trait anxiety. State anxiety relates to anxiety about an event, while trait anxiety in anxiety level as a personal characteristic. Scores can range from 20 to 80 and higher scores correlate with more anxiety.
Time Frame	holding area and PACU

Outcome Measure Data

Analysis Population Description

4-point likert scale and consists of 40 questions

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Measure Participants	13	13
STAI-State in holding area	33.5 (11.4)	32.3 (7)
STAI-Trait in holding area	33.4 (8.9)	31.8 (6.0)
STAI-State in PACU	26.1 (2.6)	27.1 (5.2)
STAI-Trait in PACU	32.3 (9.2)	32.8 (9.4)

9. Secondary Outcome

Title	Heidelberg Peri-anaesthetic Questionnaire
Description	The questionnaire consists of 38 questions assessing perioperative satisfaction about five identified themes: trust and atmosphere; fear; discomfort; treatment by personnel; and information and waiting. The questions are rated on a 4-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Higher scores indicate higher levels of satisfaction. Patient satisfaction (Heidelberg Peri-Anaesthetic Questionnaire) in PACU upon spinal resolution.
Time Frame	At PACU upon spinal resolution.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Measure Participants	13	12
Mean (Standard Deviation) [score on a scale]	97.2 (14.0)	98.9 (9.5)

10. Secondary Outcome

Title	Client Satisfaction Questionnaire (CSQ-8)
Description	The client satisfaction questionnaire (CSQ-8) is a standardized satisfaction measure and was used to collect patient feedback on the audio visual devices. Response options differ, but all are on a 4-point scale. Scores range from 8 to 32, with higher values indicating higher satisfaction. Patient feedback (CSQ8) in PACU upon spinal resolution provider feedback (form sent to providers at end of surgery day)
Time Frame	PACU upon spinal resolution

Outcome Measure Data

Analysis Population Description

This questionnaire was only administered to patients who used the audio-visual aids

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Measure Participants	0	12
Median (Inter-Quartile Range) [scores on a scale]	31.5

11. Secondary Outcome

Title	Number of Providers That Were Satisfied With Their Experience With the Audio-visual Aids
Description	Anesthesia providers were asked to provide feedback on their experience with the audio-visual aids when the randomization was for the use of the device. This was collected upon surgery end.
Time Frame	Sent to providers at end of surgery.

Outcome Measure Data

Analysis Population Description

Providers were only asked to provide feedback on the equipment when used by patients in the audiovisual aid group upon surgery end.

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Measure Participants	0	011
Count of Participants [Participants]	07 53.8%

12. Secondary Outcome

Title	Request of Sedation/Termination of AVA
Description	Request of Sedation/Termination of AVA (After consent has been obtained until spinal resolution in the recovery room, average of 6 hours)
Time Frame	From consent until spinal resolution (avg 6 hs)

Outcome Measure Data

Analysis Population Description

This outcome is only providing findings for subjects that has sedation and audiovisual aids with skin conductance monitor. It does not pertain to subjects that had sedation without the AVA.

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Measure Participants	0	13
Number of Participants (AVA Randomization)	13 100%
Request of Sedation/Termination of AVA	13 100%

13. Secondary Outcome

Title	Number of Participants With Complications
Description	The percentage of patients who experienced complications (headache, transient neurologic symptoms, nausea and vomiting, ...)
Time Frame	Intraoperatively and in the recovery room, average of 3 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sedation Only With Skin Conductance Monitor	Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor	Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
Measure Participants	13	13
Incidence of Complication Intraop	0 0%	0 0%
Incidence of Complication PACU	0 0%	0 0%

Adverse Events

Time Frame	Data will be collected on the day of surgery in the holding area, during the procedure, in the PACU until discharge, and on post-operative day 1, 6 months and 1 year; however no patients experiences any adverse events
Arm/Group Title	Sedation Only With Skin Conductance Monitor		Sedation & Audiovisual Aids With Skin Conductance Monitor
Arm/Group Description	Patients will receive traditional sedation with 2 mg of midazolam on arrival in the OR. Patients in this group will wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Midazolam Skin Conductance Monitor		Prior to surgery, patients will be asked to wear audiovisual equipment (Zeiss, Cinema ProMED) in the holding area. Patients in this group will also receive 2 mg of midazolam on arrival in OR. Patients in this group will also wear the skin conductance monitor to measure changes in levels of sympathetic discharge. Zeiss, Cinema ProMED (audiovisual equipment) Midazolam Skin Conductance Monitor
All Cause Mortality
	Sedation Only With Skin Conductance Monitor		Sedation & Audiovisual Aids With Skin Conductance Monitor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)
Serious Adverse Events
	Sedation Only With Skin Conductance Monitor		Sedation & Audiovisual Aids With Skin Conductance Monitor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Sedation Only With Skin Conductance Monitor		Sedation & Audiovisual Aids With Skin Conductance Monitor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.