The Effect of Progressive Relaxation Exercise on Pain and Kinesiophobia After Lumbar Disc Herniation Surgery

July 6, 2023 updated by: Funda Cetinkaya, Aksaray University
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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • None Selected
      • Aksaray, None Selected, Turkey, 68100
        • Aksaray University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2022

Primary Completion (Actual)

October 20, 2022

Study Completion (Actual)

December 29, 2022

Study Registration Dates

First Submitted

March 11, 2022

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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