The Effect of Progressive Relaxation Exercise on Pain and Kinesiophobia After Lumbar Disc Herniation Surgery
Primary Purpose
Lumbar Disc Herniation
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive relaxation exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Lumbar Disc Herniation
Eligibility Criteria
Inclusion Criteria:
• The patients included in the study had lumbar microdiscectomy surgery,
- Patients aged 18 and over
- Patients should not have any problems that would prevent them from expressing their pain level correctly and from understanding the information given,
- The patients do not have any psychological disorders,
- The patients do not have any other acute disease that will cause pain.
Exclusion Criteria:
• Being diagnosed with a psychiatric disorder,
- A complication (bleeding, hospital infection, etc.) developed in the patients before, during and after the operation within three days,
- Not knowing Turkish.
Sites / Locations
- Aksaray University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
Routine maintenance and Progressive relaxation exercise practice
Routine maintenance
Outcomes
Primary Outcome Measures
Tampa Kinesiophobia Scale
: It is a 17-item scale. It gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Visual Analogue Scale
It is the scale used to measure the severity of pain in patients. It is a scale whose beginning is -0- "no pain", and the other end is -10- "very severe pain" and each cm is given a numerical value at 1 centimeter (cm) intervals.
Secondary Outcome Measures
Tampa Kinesiophobia Scale
It is a 17-item scale. It gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Visual Analogue Scale
It is the scale used to measure the severity of pain in patients. It is a scale whose beginning is -0- "no pain", and the other end is -10- "very severe pain" and each cm is given a numerical value at 1 centimeter (cm) intervals.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05288634
Brief Title
The Effect of Progressive Relaxation Exercise on Pain and Kinesiophobia After Lumbar Disc Herniation Surgery
Official Title
The Effect of Progressive Relaxation Exercise on Pain and Kinesiophobia After Lumbar Disc Herniation Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
December 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aksaray 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
We aimed to assess the influence of progressive muscle relaxation exercise on kinesiophobia and pain during after lumbar disc surgery using the Visual Analog Scale (VAS) and the Tampa Kinesiophobia Scale in a prospective, randomized fashion.
Detailed Description
Lumbar disc herniation (LDH) is a common disease that is common in the society and limits the activities of individuals in daily life. Pain, which is an undesirable but expected result of surgical interventions, which are used in the treatment of diseases and play an important role in increasing the health level of people, is one of the most common postoperative complaints. The pain is sometimes severe enough to impede movement and causes paravertebral muscle spasm. Pain can also cause kinesiophobia, which is a factor that limits the person's physical activities. This study was conducted to determine the effect of progressive muscle relaxation exercises on kinesiophobia, which can be seen in parallel with pain in the postoperative period, on the pain level of patients after LDH surgery and on the kinesiophobia experienced in parallel.
The following hypotheses (H) were tested in this study:
H1. Progressive muscle relaxation exercise has an effect on reducing pain after LDH surgery.
H2. Progressive muscle relaxation exercise has an effect on reducing kinesiophobia after LDH surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Routine maintenance and Progressive relaxation exercise practice
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine maintenance
Intervention Type
Other
Intervention Name(s)
Progressive relaxation exercise
Intervention Description
Progressive relaxation exercise is a type of exercise that involves voluntary stretching and relaxation of major muscle groups in the human body, from the hands to the feet.
Primary Outcome Measure Information:
Title
Tampa Kinesiophobia Scale
Description
: It is a 17-item scale. It gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Time Frame
the day before the surgery
Title
Visual Analogue Scale
Description
It is the scale used to measure the severity of pain in patients. It is a scale whose beginning is -0- "no pain", and the other end is -10- "very severe pain" and each cm is given a numerical value at 1 centimeter (cm) intervals.
Time Frame
the day before the surgery
Secondary Outcome Measure Information:
Title
Tampa Kinesiophobia Scale
Description
It is a 17-item scale. It gets a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia.
Time Frame
third day after surgery
Title
Visual Analogue Scale
Description
It is the scale used to measure the severity of pain in patients. It is a scale whose beginning is -0- "no pain", and the other end is -10- "very severe pain" and each cm is given a numerical value at 1 centimeter (cm) intervals.
Time Frame
third day after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• The patients included in the study had lumbar microdiscectomy surgery,
Patients aged 18 and over
Patients should not have any problems that would prevent them from expressing their pain level correctly and from understanding the information given,
The patients do not have any psychological disorders,
The patients do not have any other acute disease that will cause pain.
Exclusion Criteria:
• Being diagnosed with a psychiatric disorder,
A complication (bleeding, hospital infection, etc.) developed in the patients before, during and after the operation within three days,
Not knowing Turkish.
Facility Information:
Facility Name
Aksaray University
City
Aksaray
State/Province
None Selected
ZIP/Postal Code
68100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Progressive Relaxation Exercise on Pain and Kinesiophobia After Lumbar Disc Herniation Surgery
We'll reach out to this number within 24 hrs