The Effect of Mobilization Protocol Assisted With Simulated Clinical Immersion Videos on Patients Undergoing Lumbar Spine Surgery

Sponsor

Akdeniz University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05462210

Collaborator

(none)

132

Enrollment

Location

Arms

11.6

Anticipated Duration (Months)

11.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study focused on examining the effect of mobilization protocol assisted with simulated clinical immersion videos on postoperative pain, fear of movement, mobility level and satisfaction in patients undergoing lumbar spine surgery.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Spine Surgery Lumbar Disc Herniation Lumbar Spinal Stenosis	Other: Mobilization Protocol Assisted with Simulated Clinical Immersion Videos	N/A

Detailed Description

Background: The medical condition that creates the need for lumbar spine surgery causes pain and movement restriction in patients. Ensuring safe mobilization in patients with lumbar spine surgery is important for pain management and prevention of complications.

Aim: In this study, it was aimed to examine the effect of mobilization protocol assisted with simulated clinical immersion videos on postoperative pain, fear of movement, movement level and satisfaction.

Study Design: The study was designed as interventional, pre-test, post-test, parallel group, single-blind, randomized, controlled and experimental. In the study, patients in the control group will be applied routine protocols, and patients in the intervention group will be trained on the day before surgery using the mobilization protocol assisted with simulated clinical immersion videos. In this study, stratified randomization will be used since there are two different surgical operations that patients undergo (microdiscectomy due to lumbar disc herniation and decompression with fusion due to lumbar spine stenosis). For each diagnosis, 66 patients will be included and allocated to the groups using the "block randomization method".

Methods: In this study, pain, fear of movement, movement level and satisfaction will be recorded at the first postoperative mobilization and discharge.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Participants and statistician are blinded.

Primary Purpose:

Other

Official Title:

The Effect of Mobilization Protocol Assisted With Simulated Clinical Immersion Videos on Postoperative Pain, Fear of Movement, Mobility Level and Satisfaction in Patients Undergoing Lumbar Spine Surgery: A Randomized, Controlled, Single-Blind Study

Actual Study Start Date :

Jan 11, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control group The first mobilization of patients undergoing surgical treatment for lumbar disc herniation and lumbar spine stenosis in the clinics where the study will be conducted is routinely performed within the first 24 hours after surgery. When the data collection process of the control group is completed, the data will be integrated with the mobilization protocol assisted with simulated clinical immersion videos created for the research.
Experimental: Intervention group Mobilization Protocol Assisted with Simulated Clinical Immersion Videos Simulated clinical immersion videos created for the mobilization protocol for patients in the intervention group will be sent to their smartphones once they are admitted to the clinic. The videos prepared within the scope of the mobilization protocol will be watched by patients in company with the researcher the day before the operation, their questions will be answered, and the correct mobilization techniques will be shown practically. It is expected that patients watch the videos at least four times, as twice with the researcher and twice by themselves.	Other: Mobilization Protocol Assisted with Simulated Clinical Immersion Videos Mobilization Protocol Assisted with Simulated Clinical Immersion Videos Simulated clinical immersion videos created for the mobilization protocol for patients in the intervention group will be sent to their smartphones once they are admitted to the clinic. The videos prepared within the scope of the mobilization protocol will be watched by patients in company with the researcher the day before the operation, their questions will be answered, and the correct mobilization techniques will be shown practically. It is expected that patients watch the videos at least four times, as twice with the researcher and twice by themselves.

Arm

Intervention/Treatment

No Intervention: Control group

The first mobilization of patients undergoing surgical treatment for lumbar disc herniation and lumbar spine stenosis in the clinics where the study will be conducted is routinely performed within the first 24 hours after surgery. When the data collection process of the control group is completed, the data will be integrated with the mobilization protocol assisted with simulated clinical immersion videos created for the research.

Experimental: Intervention group

Mobilization Protocol Assisted with Simulated Clinical Immersion Videos Simulated clinical immersion videos created for the mobilization protocol for patients in the intervention group will be sent to their smartphones once they are admitted to the clinic. The videos prepared within the scope of the mobilization protocol will be watched by patients in company with the researcher the day before the operation, their questions will be answered, and the correct mobilization techniques will be shown practically. It is expected that patients watch the videos at least four times, as twice with the researcher and twice by themselves.

Other: Mobilization Protocol Assisted with Simulated Clinical Immersion Videos

Outcome Measures

Primary Outcome Measures

Back and leg pain [Changes in hospitalization, first mobilization after surgery and the day of discharge. 1. Day of hospitalization (24 hours) 2. The first 24 hours after surgery 3. The day of discharge (24 hours)]
The Visual Analog Scale (VAS) is a straight horizontal line of 100 mm. One end describes no paint at all while the other describes an excessive amount of pain. VAS score is calculated by measuring in millimeters from the left end of the line to the point marked by the patient. VAS will be used to assess low back pain (VAS-BP) and right and left leg pain (VAS-LP) separately (Nayak, Coats, Abdullah, Stein, & Malhotra, 2015).
Fear of Movement [Changes in hospitalization, first mobilization after surgery and the day of discharge. 1. Day of hospitalization (24 hours) 2. The first 24 hours after surgery 3. The day of discharge (24 hours)]
Tampa Scale for Kinesiophobia (TKS): The TKS is used to assess the subjective degree of kinesiophobia or fear of movement, and consists of 17 items. The 4-point Likert-type scale ranges from 1 to 4 (1=Strongly disagree, 4=Completely agree). The overall score is calculated after reverse scoring the items 4, 8, 12 and 16. The overall scale score ranges between 17 and 68, and higher scores indicate higher level of kinesiophobia (Yılmaz et al., 2011).
Mobility Level [Changes in hospitalization, first mobilization after surgery and the day of discharge. 1. Day of hospitalization (24 hours) 2. The first 24 hours after surgery 3. The day of discharge (24 hours)]
Patient Mobility Scale: The level of pain and difficulty that patients experience doing four activities (turning from side to side in bed, sitting on the edge of the bed, sitting up at the side of the bed, walking in hospital room) during the postoperative period are assessed using a 15-cm visual analogue, throughout which verbal expressions are included. The lowest and highest possible scores obtained from each item ranges between 0 and 15, and the overall scale score ranges between 0 and 120. Higher scores indicate higher level of pain and difficulty (Ayoğlu, 2011).

Secondary Outcome Measures

Patient Satisfaction [The day of discharge (24 hours)]
Patients' satisfaction with the care they receive will be assessed using a Visual Analog Scale. The Visual Analog Scale (VAS) is a straight horizontal line of 100 mm. One end describes not satisfied at all, while the other describes high level of satisfaction. VAS score is calculated by measuring in millimeters from the left end of the line to the point marked by the patient. Higher scores indicate higher level of satisfaction.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

According to the ICD-10 Codes: Those with S33.0-Traumatic rupture of lumbar intervertebral disc, G55-Nerve root and plexus compressions, M54.4-Lumbago with sciatica, underwent lumbar disc herniation surgery (microdiscectomy) due to diagnosed with M54.5-Low back pain,
According to the ICD-10 Codes: Those with M48.0-Spinal stenosis, G55-Nerve root and plexus compressions, M54.4-Lumbago with sciatica, underwent lumbar spine stenosis surgery (due to diagnosed with M54.5-Low back pain,
Aged 18 and over,
With no hearing, vision, comprehension and speech impairments,
Volunteering to participate in the research,
Using a smartphone will be included in the study.

Exclusion Criteria:

Those under the age of 18,
Underwent revision lumbar spine surgery,
With mental or physical disabilities to receive the mobilization training that will be provided before the operation will not be included in the sample.