- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05288634
The Effect of Progressive Relaxation Exercise on Pain and Kinesiophobia After Lumbar Disc Herniation Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
None Selected
-
Aksaray, None Selected, Turkey, 68100
- Aksaray University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Routine maintenance and Progressive relaxation exercise practice
|
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.
|
|
No Intervention: Control
Routine maintenance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Kinesiophobia Scale
Time Frame: the day before the surgery
|
: 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.
|
the day before the surgery
|
|
Visual Analogue Scale
Time Frame: the day before the surgery
|
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.
|
the day before the surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Kinesiophobia Scale
Time Frame: third day after surgery
|
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.
|
third day after surgery
|
|
Visual Analogue Scale
Time Frame: third day after surgery
|
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.
|
third day after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/01-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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