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

Primary Purpose

Lumbar Spine Surgery, Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mobilization Protocol Assisted with Simulated Clinical Immersion Videos
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lumbar Spine Surgery focused on measuring Mobilization, Nursing, Spinal Surgery, Pain, Fear of Movement, Patient Satisfaction, Simulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Akdeniz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

The first mobilization of patients undergoing surgical treatment for lumbar disc herniation 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.

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.

Outcomes

Primary Outcome Measures

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).
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 (Yılmaz et al., 2011).
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 (Ayoğlu, 2011).

Secondary Outcome Measures

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.

Full Information

First Posted
June 30, 2022
Last Updated
May 24, 2023
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT05462210
Brief Title
The Effect of Mobilization Protocol Assisted With Simulated Clinical Immersion Videos on Patients Undergoing Lumbar Spine Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
May 22, 2023 (Actual)
Study Completion Date
May 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Surgery, Lumbar Disc Herniation
Keywords
Mobilization, Nursing, Spinal Surgery, Pain, Fear of Movement, Patient Satisfaction, Simulation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants and statistician are blinded.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The first mobilization of patients undergoing surgical treatment for lumbar disc herniation 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.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mobilization Protocol Assisted with Simulated Clinical Immersion Videos
Intervention Description
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.
Primary Outcome Measure Information:
Title
Back and leg pain
Description
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).
Time Frame
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)
Title
Fear of Movement
Description
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).
Time Frame
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)
Title
Mobility Level
Description
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).
Time Frame
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 Outcome Measure Information:
Title
Patient Satisfaction
Description
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.
Time Frame
The day of discharge (24 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Akdeniz University Hospital
City
Antalya
ZIP/Postal Code
07058
Country
Turkey

12. IPD Sharing Statement

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

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