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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05288634
Other study ID # 2020/01-25
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 14, 2022
Est. completion date December 29, 2022

Study information

Verified date July 2023
Source Aksaray University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 29, 2022
Est. primary completion date October 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Progressive relaxation exercise
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.

Locations

Country Name City State
Turkey Aksaray University Aksaray None Selected

Sponsors (1)

Lead Sponsor Collaborator
Aksaray University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. the day before the surgery
Primary 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. the day before the surgery
Secondary 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. third day after surgery
Secondary 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. third day after surgery
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