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

Lumbar Disc Herniation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05462210
• Other study ID #: KAEK-312
• Status: Completed
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: May 22, 2023

Study information

• Verified date: May 2023
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, the patients will be distributed to the groups by 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 22, 2023
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

• 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.

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Lumbar Spine Surgery

Intervention

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.

Locations

Country	Name	City	State
Turkey	Akdeniz University Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Back and leg pain	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).	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)
Primary	Fear of Movement	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 (Yilmaz et al., 2011).	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)
Primary	Mobility Level	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 (Ayoglu, 2011).	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)
Secondary	Patient Satisfaction	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.	The day of discharge (24 hours)