Progressive Relaxation ExerciseNCT07419958
Effects of Relaxation Exercises on Fear of Movement, Pain, and Quality of Life in Lumbar Disc Herniation Patients
A study testing progressive relaxation exercise in people with Progressive Relaxation Exercise and Hernia, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates whether progressive relaxation exercises can reduce fear of movement, pain, and improve quality of life in patients with lumbar disc herniation. Participants are randomly assigned to either a control group receiving standard care or an intervention group performing supervised relaxation exercises… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Progressive Relaxation Exercise, Hernia, Pain
- What is being tested?
- progressive relaxation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Diagnosis of lumbar disc herniation confirmed by clinical evaluation and imaging findings
- Presence of bulging or protruding lumbar disc herniation
- Ability to participate in exercise sessions
- Willingness to participate and provide informed consent
Who cannot join
- History of lumbar spine surgery
- Presence of rheumatologic disease
- Neurological, orthopedic, or systemic conditions that may interfere with participation or assessment
- Presence of spinal implants or metal instrumentation
- Any medical condition preventing safe participation in exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Progressive Relaxation Exercises on Kinesiophobia, Pain, and Quality of Life in Patients With Lumbar Disc Herniation: A Randomized Controlled Trial
This study evaluates whether progressive relaxation exercises can reduce fear of movement, pain, and improve quality of life in patients with lumbar disc herniation. Participants are randomly assigned to either a control group receiving standard care or an intervention group performing supervised relaxation exercises in addition to standard care. The exercise program is conducted three times per week for 15 sessions. Outcomes are measured before and after the intervention using validated scales assessing kinesiophobia, pain intensity, disability, and quality of life. The goal is to determine whether adding relaxation exercises provides additional benefits for patients with lumbar disc herniation.
Read the detailed description
Lumbar disc herniation is a common musculoskeletal condition that can cause pain, functional limitation, and fear of movement, which may negatively affect daily activities and quality of life. Psychological factors such as kinesiophobia can contribute to disability and may interfere with rehabilitation outcomes. Relaxation-based approaches are noninvasive interventions that may help reduce muscle tension, pain perception, and movement-related fear.
This randomized controlled study investigates the effects of progressive relaxation exercises in patients diagnosed with lumbar disc herniation. Participants are assigned to either a control group receiving standard care or an intervention group receiving progressive relaxation exercises in addition to standard care. The exercise sessions are supervised and delivered over a structured treatment period. Outcome measures assess changes in fear of movement, pain severity, functional disability, and quality of life using validated assessment tools. The study aims to determine whether progressive relaxation exercises provide additional clinical benefit beyond standard care for this patient population. avoids repeating data entered elsewhere (dates, numbers, site names, etc.) is professional and registry-appropriate
- Conditions
- Progressive Relaxation Exercise, Hernia, Pain, Kinesiophobia
- Being tested
- progressive relaxation exercise
- Keywords
- Disc Herniation, Muscle Relaxation, Pain, Progressive Relaxation Exercise, Quality of Life
- Medical subject headings
- Hernia, Pain, Kinesiophobia, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive relaxation exerciseOther
- The exercises were performed under the supervision of a physiotherapist by using a program developed by Dr. Jonathon Smith and verbal instructions .
- The patients were asked to wear comfortable clothes and take off their shoes during the session.
- Before the exercise, the patients were taught to breathe deeply through the nose and perform expression by positioning the lips as if making a "U" sound.
- The exercises were performed in three sets for each session for the hip, abdominal, waist, back, chest, shoulder and neck muscle groups, as described below
- The participant takes a deep breath as taught previously.
- The participant performs muscle contraction along with deep inspiration.
- The participant then ends the contraction while exhaling through the mouth and relaxing.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in the control group were asked to return to their routine activities. |
| progressive relaxation exercise group | Active comparator | * The exercises were performed under the supervision of a physiotherapist by using a program developed by Dr. Jonathon Smith and verbal instructions.
* The patients were asked to wear comfortable clothes and take off their shoes during the session.
* Before the exercise, the patients were taught to breathe deeply through the nose and perform expression by positioning the lips as if making a "U" sound.
* The exercises were performed in three sets for each session for the hip, abdominal, waist, back, chest, shoulder and neck muscle groups, as described below
1. The participant takes a deep breath as taught previously.
2. The participant performs muscle contraction along with deep inspiration.
3. The participant then ends the contraction while exhaling through the mouth and relaxing. Receives: Other: progressive relaxation exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kinesiophobia Score
The Tampa Scale for Kinesiophobia is a validated self-report questionnaire used to assess fear of movement related to pain or injury. Scores range from 17 to 68, with higher scores indicating greater fear of movement. Change is calculated as the difference between pre-intervention and post-intervention scores.
Measured: Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)
Change in Pain Intensity (Visual Analog Scale)
Pain intensity is assessed using the Visual Analog Scale (VAS), a validated measure consisting of a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants rate their pain at rest and during movement. Change is calculated as the difference between pre-intervention and post-intervention scores.
Measured: Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)
Change in Functional Disability Score (Oswestry Disability Index)
Functional disability is assessed using the Oswestry Disability Index, a validated questionnaire that measures the degree of disability related to low back pain. Scores range from 0 to 100, with higher scores indicating greater disability. Change is calculated as the difference between pre-intervention and post-intervention scores.
Measured: Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)
Change in Quality of Life Score (Short Form-36 Health Survey)
Quality of life is assessed using the Short Form-36 Health Survey, a validated questionnaire that evaluates health-related quality of life across multiple domains. Scores range from 0 to 100 for each domain, with higher scores indicating better health status. Change is calculated as the difference between pre-intervention and post-intervention scores.
Measured: Baseline and immediately after completion of the 15-session intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Dec 2024
- Primary completion1 May 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Relaxation ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two parallel groups: a control group receiving standard care or an intervention group receiving progressive relaxation exercises in addition to standard care. Both groups are followed over the same study period, and outcomes are assessed before and after the intervention to compare changes between groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlker DEMİR, Hasan Kalyoncu University
- Investigators
- Ilker Demir, PhD, Principal investigator, Inonu University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419958
- Sponsor's protocol ID
- 2024/157
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Relaxation Exercises on Kinesiophobia, Pain, and Quality of Life in Patients With Lumbar Disc Herniation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07419958
- Acronym / sponsor ID
- 2024/157
- Conditions
- Progressive Relaxation Exercise, Hernia, Pain, Kinesiophobia
- Keywords
- Disc Herniation, Muscle Relaxation, Pain, Progressive Relaxation Exercise, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether progressive relaxation exercises can reduce fear of movement, pain, and improve quality of life in patients with lumbar disc herniation. Participants are randomly assigned to either a control group receiving standard care or an intervention group performing supervised relaxation exercises in addition to standard care. The exercise program is conducted three times per week for 15 sessions. Outcomes are measured before and after the intervention using validated scales assessing kinesiophobia, pain intensity, disability, and quality of life. The goal is to determine whether adding relaxation exercises provides additional benefits for patients with lumbar disc herniation.
Detailed description
Lumbar disc herniation is a common musculoskeletal condition that can cause pain, functional limitation, and fear of movement, which may negatively affect daily activities and quality of life. Psychological factors such as kinesiophobia can contribute to disability and may interfere with rehabilitation outcomes. Relaxation-based approaches are noninvasive interventions that may help reduce muscle tension, pain perception, and movement-related fear.
This randomized controlled study investigates the effects of progressive relaxation exercises in patients diagnosed with lumbar disc herniation. Participants are assigned to either a control group receiving standard care or an intervention group receiving progressive relaxation exercises in addition to standard care. The exercise sessions are supervised and delivered over a structured treatment period. Outcome measures assess changes in fear of movement, pain severity, functional disability, and quality of life using validated assessment tools. The study aims to determine whether progressive relaxation exercises provide additional clinical benefit beyond standard care for this patient population. avoids repeating data entered elsewhere (dates, numbers, site names, etc.) is professional and registry-appropriate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel groups: a control group receiving standard care or an intervention group receiving progressive relaxation exercises in addition to standard care. Both groups are followed over the same study period, and outcomes are assessed before and after the intervention to compare changes between groups.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in the control group were asked to return to their routine activities. |
| progressive relaxation exercise group | Active comparator | Other: progressive relaxation exercise* The exercises were performed under the supervision of a physiotherapist by using a program developed by Dr. Jonathon Smith and verbal instructions. * The patients were asked to wear comfortable clothes and take off their shoes during the session. * Before the exercise, the patients were taught to breathe deeply through the nose and perform expression by positioning the lips as if making a "U" sound. * The exercises were performed in three sets for each session for the hip, abdominal, waist, back, chest, shoulder and neck muscle groups, as described below 1. The participant takes a deep breath as taught previously. 2. The participant performs muscle contraction along with deep inspiration. 3. The participant then ends the contraction while exhaling through the mouth and relaxing. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- Diagnosis of lumbar disc herniation confirmed by clinical evaluation and imaging findings
- Presence of bulging or protruding lumbar disc herniation
- Ability to participate in exercise sessions
- Willingness to participate and provide informed consent
Key exclusion criteria (5 listed)
- History of lumbar spine surgery
- Presence of rheumatologic disease
- Neurological, orthopedic, or systemic conditions that may interfere with participation or assessment
- Presence of spinal implants or metal instrumentation
- Any medical condition preventing safe participation in exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| progressive relaxation exercise* The exercises were performed under the supervision of a physiotherapist by using a program developed by Dr. Jonathon Smith and verbal instructions . * The patients were asked to wear comfortable clothes and take off their shoes during the session. * Before the exercise, the patients were taught to breathe deeply through the nose and perform expression by positioning the lips as if making a "U" sound. * The exercises were performed in three sets for each session for the hip, abdominal, waist, back, chest, shoulder and neck muscle groups, as described below 1. The participant takes a deep breath as taught previously. 2. The participant performs muscle contraction along with deep inspiration. 3. The participant then ends the contraction while exhaling through the mouth and relaxing. | Other | progressive relaxation exercise group |
Primary outcome
Change in Kinesiophobia Score
Time frame: Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)
The Tampa Scale for Kinesiophobia is a validated self-report questionnaire used to assess fear of movement related to pain or injury. Scores range from 17 to 68, with higher scores indicating greater fear of movement. Change is calculated as the difference between pre-intervention and post-intervention scores.
Change in Pain Intensity (Visual Analog Scale)
Time frame: Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)
Pain intensity is assessed using the Visual Analog Scale (VAS), a validated measure consisting of a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants rate their pain at rest and during movement. Change is calculated as the difference between pre-intervention and post-intervention scores.
Change in Functional Disability Score (Oswestry Disability Index)
Time frame: Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)
Functional disability is assessed using the Oswestry Disability Index, a validated questionnaire that measures the degree of disability related to low back pain. Scores range from 0 to 100, with higher scores indicating greater disability. Change is calculated as the difference between pre-intervention and post-intervention scores.
Change in Quality of Life Score (Short Form-36 Health Survey)
Time frame: Baseline and immediately after completion of the 15-session intervention
Quality of life is assessed using the Short Form-36 Health Survey, a validated questionnaire that evaluates health-related quality of life across multiple domains. Scores range from 0 to 100 for each domain, with higher scores indicating better health status. Change is calculated as the difference between pre-intervention and post-intervention scores.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilker Demir, PhD principal investigator
Inonu University, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progressive relaxation exercise in people with Progressive Relaxation Exercise and Hernia, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Kinesiophobia Score (time frame: Baseline and immediately after completion of the 15-session intervention (approximately 5 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.