Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04742543

Collaborator

(none)

100

Enrollment

Location

Arms

21.4

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the effectiveness of virtual reality glasses as a distraction technique in the management of acute pain and anxiety during conization of cervix uterus under local anesthesia

Condition or Disease	Intervention/Treatment	Phase
Dysplasia, Cervix	Device: SootheVR: AppliedVR, Los Angeles, California a head-mounted display	N/A

Detailed Description

A prospective, open-label, randomized control trial in a tertiary university affiliated medical center between March 2021 to March 2023. Overall, 100 women referred for conization of cervix due to cervical dysplasia will be randomly allocated to undergo conization either with the use of virtual reality glasses (study group) or with standard treatment (control group). The primary outcome measures will include self-reported pain, anxiety scores, and vital signs as an indirect measurement of pain and anxiety, including pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes will be measured as numeric rating scores.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

: Parallel Assignment: Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Virtual Reality During Conization of Cervix Uterus Under Local Anesthesia

Actual Study Start Date :

May 19, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual reality glasses Patients referred for conization due to cervical dysplasia under local anesthesia. In this arm , patients will be allocated to undergo the conization procedure with Virtual reality glasses on	Device: SootheVR: AppliedVR, Los Angeles, California a head-mounted display For the study group, virtual reality content will be shown to the participant for the duration of the conization procedure through a head-mounted display, RelieVRTM. The default VR content for the trial will be "swimming with dolphins" or any other content chosen by the participant
No Intervention: No intervention. standard treatment Patients referred for conization due to cervical dysplasia under local anesthesia. In this arm , patients will be allocated to undergo the conization procedure without virtual reality glasses (no intervention)

Arm

Intervention/Treatment

Experimental: Virtual reality glasses

Patients referred for conization due to cervical dysplasia under local anesthesia. In this arm , patients will be allocated to undergo the conization procedure with Virtual reality glasses on

Device: SootheVR: AppliedVR, Los Angeles, California a head-mounted display

For the study group, virtual reality content will be shown to the participant for the duration of the conization procedure through a head-mounted display, RelieVRTM. The default VR content for the trial will be "swimming with dolphins" or any other content chosen by the participant

No Intervention: No intervention. standard treatment

Patients referred for conization due to cervical dysplasia under local anesthesia. In this arm , patients will be allocated to undergo the conization procedure without virtual reality glasses (no intervention)

Outcome Measures

Primary Outcome Measures

Assessments of pain through pain score parameter [20 minutes]
Assessments of pain through pain score parameter of the NRS questionnaire. Pain will be measured using the Numeric Rating Scale (NRS) which is a 11 point scale from 0 to 10 which is a validated score of measuring pain in which 0 is no pain and 10 is the worst imaginable pain
Assessments of pain through physiological parameters [20 minutes]
Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using heart rate beats per minute

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients over 18 years referred for conization of cervix due to cervical dysplasia

Exclusion Criteria:

patients under 18 years
pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lis Maternity Hospital, Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	64239

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT04742543

Other Study ID Numbers:

0097-21-TLV

First Posted:

Feb 8, 2021

Last Update Posted:

Jun 2, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tel-Aviv Sourasky Medical Center

cervical dysplasia; conization; anxiety; pain; virtual reality

Additional relevant MeSH terms:

Uterine Cervical Dysplasia

Study Results

No Results Posted as of Jun 2, 2022