Spinal Stenosis LumbarNCT05253326
The Effect of Progressive Muscle Relaxation Exercises on Pain and Disability After Spinal Surgery
A study testing Progressive Muscle Relaxation Exercises in people with Spinal Stenosis Lumbar, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned as a randomized controlled experimental study to determine the effect of progressive muscle relaxation exercises on pain and disability in patients undergoing spinal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Stenosis Lumbar
- What is being tested?
- Progressive Muscle Relaxation Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having undergone spinal surgery (such as Discectomy, Laminectomy, Spinal fusion, Foraminatomy),
- 18 years of age or older
- Agreeing to apply progressive relaxation exercises and willing and willing to participate in the study,
- Having no medically diagnosed health problems (neurological, psychiatric, orthopedic) that will prevent learning and practicing progressive muscle relaxation exercises,
- Patients who do not know and practice progressive relaxation exercises before will be included in the study.
Who cannot join
- Patients who will undergo emergency surgery,
- Do not want to apply progressive relaxation exercises,
- Do not apply them as desired during the working process,
- Those have health problems (neurological, psychiatric, orthopedic) that may affect their ability to do the exercises
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sultan 2. Abdülhamid Han Training and Research Hospital
Istanbul, Üsküdar
Eda Polat, MSc, +905415660731, edda_akyol@hotmail.com
Özlem İbrahimoğlu, PhD, +905436195971, oogutlu@gmail.com
About this study
This study was planned as a randomized controlled experimental study to determine the effect of progressive muscle relaxation exercises on pain and disability in patients undergoing spinal surgery.
Read the detailed description
Low back pain is not a disease in itself, but a symptom with many causes. The term "low back pain" means pain felt close to the midline of the lumbar or sacral region. It is a common problem in the society that causes loss of workforce and is accepted as a common cause of disability (functional limitation). Vertebral compression fractures, degenerative joint disease, spinal stenosis and various mechanical disorders are among the causes of low back pain. Although due to other pathologies, the general opinion is that lumbar disc prolapses often suppress or irritate one or more nerve roots in the lumbosacral region, causing pain that radiates to certain areas of the hips or legs. This pain is defined as lumbosacral radiculopathy. Although lumbosacral radiculopathy is treated conservatively in many patients, surgery is a common option in patients with persistent symptoms. The aim of surgical treatment methods such as discectomy, laminectomy, foraminotomy and spinal fusion is to release the neural structures by removing the herniated disc that compresses the nerve root and dura. Although there are various outcomes to measure the success of treatment after lumbar disc surgery, reduction of pain and returning to normal activities remain the main goals for patients. In the studies performed, it was determined that almost every patient had low back and leg pain, low quality of life scores and high disability scores before the surgery, while it was determined that there was an improvement in pain and other areas after the surgery. However, in the literature, complete relief after surgery is rarely seen, and symptoms persist in patients; It is stated that the severity varies from minor and non-irritating to severe and debilitating. Persistent and recurrent radicular pain after lumbar surgery is often associated with compression of the nerve roots. Zanoli et al. (2001) found that after surgical interventions for degenerative lumbar spine diseases, tolerable pain continued in the same way or increased in the 4th and 12th months postoperatively. Häkkinen et al. (2004) found that although there was improvement in postoperative back and leg pain, 25% of the patients still had moderate or severe leg pain at the 2nd month postoperatively, and approximately 30% perceived moderate or severe disability. Similarly, Lee et al. (2017) also found that although there was an improvement in the level of pain after surgery, the pain continued at a moderate level in the 3rd, 6th and 12th months. Continuing pain, motor deficits and decreased functional capacity after lumbar disc surgery may also cause loss of work force. In a study on the subject, it was determined that 80% of the patients re-reported due to pain or retired early after a 2-month routine health report after lumbar disc surgery. Controlling pain is important in terms of relaxation of the individual, increasing the quality of life, reducing complications and shortening the length of hospital stay. Pharmacological and non-pharmacological methods are used in the control of pain. One of the non-pharmacological methods is "relaxation". Passive relaxation, biofeedback, autogenic relaxation, basic breathing exercises, and progressive relaxation exercises (PRE) are among the relaxation techniques that require the active participation of the individual. Relaxation therapy has recently become an integral part of the care of individuals with chronic diseases due to its benefits such as reducing anxiety and stress, distracting attention from pain, relieving muscle tension and contractions, facilitating sleep, reducing fatigue and sensitivity to pain. With relaxation therapy, individuals can notice the tensions in their bodies, control their muscles, and learn to relax and relax tense parts of the body. One of the simplest and easiest to learn relaxation techniques is progressive relaxation exercises. These exercises are a series of procedures involving deep breathing and stretching and relaxation cycles in 50 different muscle groups to increase awareness of muscle tension in the body and learn to release these muscles. The technique promotes the systematic relaxation of the main muscle groups of the body for the purpose of physical and mental relaxation, reduction of response to stress, reduction of skeletal muscle contractions and the sensation of pain. In the literature, there are many studies related to progressive relaxation exercises and pain in different patient groups. In studies on musculoskeletal pain, it has been shown that progressive relaxation exercises significantly reduce the pain of patients with chronic neck pain (Lauche et al. 2013), and have a significant effect on pain, stress and disability levels in patients with chronic low back pain. In a systematic review study, it is stated that PRE is effective in reducing chronic low back pain and improving functional status. No study has been found examining the effect of PRE on postoperative pain and disability in patients undergoing lumbar surgery.
- Conditions
- Spinal Stenosis Lumbar
- Being tested
- Progressive Muscle Relaxation Exercises
- Keywords
- Lumbar Surgery, Progressive muscle relaxation, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle Relaxation ExercisesOther
It is among the relaxation techniques that require the active participation of the individual.
| Study group | Role | What they receive |
|---|---|---|
| Exercises Group | Experimental | Patients will be taught Progressive Muscle Relaxation Exercises before the surgery and will be applied twice a week for 2 months after the surgery. Receives: Other: Progressive Muscle Relaxation Exercises |
| Control Group | No intervention | Patients in the control group will receive standard care that includes all medical and non-medical treatments in the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive Muscle Relaxation Exercises
Visual Analogue Scale scores will decrease after progressive muscle relaxation exercises. The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad.
Measured: 12 months
Progressive Muscle Relaxation Exercises
Roland-Morris Disability Questionnaire will decrease after progressive muscle relaxation exercises.There will be a total score between 0-24. A high score indicates severe disability.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 May 2022
- Primary completion1 Feb 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Spinal Stenosis LumbarStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Eda Polat, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253326
- Sponsor's protocol ID
- IstanbulMU10
- Status last verified
- Nov 2024
- First submitted
- 8 Feb 2022
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will be shared with other researchers by holding a meeting after the data collection is completed.
Publications
Akmese ZB, Oran NT. Effects of Progressive Muscle Relaxation Exercises Accompanied by Music on Low Back Pain and Quality of Life During Pregnancy. J Midwifery Womens Health. 2014 Sep-Oct;59(5):503-9. doi: 10.1111/jmwh.12176. Epub 2014 Jun 25.
PubMed 24965313Atya AM. The validity of spinal mobility for prediction of functional disability in male patients with low back pain. J Adv Res. 2013 Jan;4(1):43-9. doi: 10.1016/j.jare.2012.01.002. Epub 2012 Feb 16.
PubMed 25685400Casser HR, Seddigh S, Rauschmann M. Acute Lumbar Back Pain. Dtsch Arztebl Int. 2016 Apr 1;113(13):223-34. doi: 10.3238/arztebl.2016.0223.
PubMed 27120496Chen YL, Francis AJ. Relaxation and imagery for chronic, nonmalignant pain: effects on pain symptoms, quality of life, and mental health. Pain Manag Nurs. 2010 Sep;11(3):159-68. doi: 10.1016/j.pmn.2009.05.005. Epub 2009 Sep 8.
PubMed 20728065Fekete TF, Haschtmann D, Kleinstuck FS, Porchet F, Jeszenszky D, Mannion AF. What level of pain are patients happy to live with after surgery for lumbar degenerative disorders? Spine J. 2016 Apr;16(4 Suppl):S12-8. doi: 10.1016/j.spinee.2016.01.180. Epub 2016 Feb 2.
PubMed 26850172Hasenbring MI, Plaas H, Fischbein B, Willburger R. The relationship between activity and pain in patients 6 months after lumbar disc surgery: do pain-related coping modes act as moderator variables? Eur J Pain. 2006 Nov;10(8):701-9. doi: 10.1016/j.ejpain.2005.11.004. Epub 2006 Jan 19.
PubMed 16426878Kucukdeveci AA, Tennant A, Elhan AH, Niyazoglu H. Validation of the Turkish version of the Roland-Morris Disability Questionnaire for use in low back pain. Spine (Phila Pa 1976). 2001 Dec 15;26(24):2738-43. doi: 10.1097/00007632-200112150-00024.
PubMed 11740366Lauche R, Materdey S, Cramer H, Haller H, Stange R, Dobos G, Rampp T. Effectiveness of home-based cupping massage compared to progressive muscle relaxation in patients with chronic neck pain--a randomized controlled trial. PLoS One. 2013 Jun 7;8(6):e65378. doi: 10.1371/journal.pone.0065378. Print 2013.
PubMed 23762355Lee CS, Kang KC, Chung SS, Park WH, Shin WJ, Seo YG. How does back muscle strength change after posterior lumbar interbody fusion? J Neurosurg Spine. 2017 Feb;26(2):163-170. doi: 10.3171/2016.7.SPINE151132. Epub 2016 Oct 14.
PubMed 27740397Mancuso CA, Reid MC, Duculan R, Girardi FP. Improvement in Pain After Lumbar Spine Surgery: The Role of Preoperative Expectations of Pain Relief. Clin J Pain. 2017 Feb;33(2):93-98. doi: 10.1097/AJP.0000000000000383.
PubMed 27022672Mannion AF, Porchet F, Kleinstuck FS, Lattig F, Jeszenszky D, Bartanusz V, Dvorak J, Grob D. The quality of spine surgery from the patient's perspective. Part 1: the Core Outcome Measures Index in clinical practice. Eur Spine J. 2009 Aug;18 Suppl 3(Suppl 3):367-73. doi: 10.1007/s00586-009-0942-8. Epub 2009 Mar 25.
PubMed 19319578
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation Exercises on Pain and Disability After Spinal Surgery
- ClinicalTrials.gov ID
- NCT05253326
- Acronym / sponsor ID
- IstanbulMU10
- Conditions
- Spinal Stenosis Lumbar
- Keywords
- Lumbar Surgery, Progressive muscle relaxation, Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 23 Feb 2022 (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 was planned as a randomized controlled experimental study to determine the effect of progressive muscle relaxation exercises on pain and disability in patients undergoing spinal surgery.
Detailed description
Low back pain is not a disease in itself, but a symptom with many causes. The term "low back pain" means pain felt close to the midline of the lumbar or sacral region. It is a common problem in the society that causes loss of workforce and is accepted as a common cause of disability (functional limitation). Vertebral compression fractures, degenerative joint disease, spinal stenosis and various mechanical disorders are among the causes of low back pain. Although due to other pathologies, the general opinion is that lumbar disc prolapses often suppress or irritate one or more nerve roots in the lumbosacral region, causing pain that radiates to certain areas of the hips or legs. This pain is defined as lumbosacral radiculopathy. Although lumbosacral radiculopathy is treated conservatively in many patients, surgery is a common option in patients with persistent symptoms. The aim of surgical treatment methods such as discectomy, laminectomy, foraminotomy and spinal fusion is to release the neural structures by removing the herniated disc that compresses the nerve root and dura. Although there are various outcomes to measure the success of treatment after lumbar disc surgery, reduction of pain and returning to normal activities remain the main goals for patients. In the studies performed, it was determined that almost every patient had low back and leg pain, low quality of life scores and high disability scores before the surgery, while it was determined that there was an improvement in pain and other areas after the surgery. However, in the literature, complete relief after surgery is rarely seen, and symptoms persist in patients; It is stated that the severity varies from minor and non-irritating to severe and debilitating. Persistent and recurrent radicular pain after lumbar surgery is often associated with compression of the nerve roots. Zanoli et al. (2001) found that after surgical interventions for degenerative lumbar spine diseases, tolerable pain continued in the same way or increased in the 4th and 12th months postoperatively. Häkkinen et al. (2004) found that although there was improvement in postoperative back and leg pain, 25% of the patients still had moderate or severe leg pain at the 2nd month postoperatively, and approximately 30% perceived moderate or severe disability. Similarly, Lee et al. (2017) also found that although there was an improvement in the level of pain after surgery, the pain continued at a moderate level in the 3rd, 6th and 12th months. Continuing pain, motor deficits and decreased functional capacity after lumbar disc surgery may also cause loss of work force. In a study on the subject, it was determined that 80% of the patients re-reported due to pain or retired early after a 2-month routine health report after lumbar disc surgery. Controlling pain is important in terms of relaxation of the individual, increasing the quality of life, reducing complications and shortening the length of hospital stay. Pharmacological and non-pharmacological methods are used in the control of pain. One of the non-pharmacological methods is "relaxation". Passive relaxation, biofeedback, autogenic relaxation, basic breathing exercises, and progressive relaxation exercises (PRE) are among the relaxation techniques that require the active participation of the individual. Relaxation therapy has recently become an integral part of the care of individuals with chronic diseases due to its benefits such as reducing anxiety and stress, distracting attention from pain, relieving muscle tension and contractions, facilitating sleep, reducing fatigue and sensitivity to pain. With relaxation therapy, individuals can notice the tensions in their bodies, control their muscles, and learn to relax and relax tense parts of the body. One of the simplest and easiest to learn relaxation techniques is progressive relaxation exercises. These exercises are a series of procedures involving deep breathing and stretching and relaxation cycles in 50 different muscle groups to increase awareness of muscle tension in the body and learn to release these muscles. The technique promotes the systematic relaxation of the main muscle groups of the body for the purpose of physical and mental relaxation, reduction of response to stress, reduction of skeletal muscle contractions and the sensation of pain. In the literature, there are many studies related to progressive relaxation exercises and pain in different patient groups. In studies on musculoskeletal pain, it has been shown that progressive relaxation exercises significantly reduce the pain of patients with chronic neck pain (Lauche et al. 2013), and have a significant effect on pain, stress and disability levels in patients with chronic low back pain. In a systematic review study, it is stated that PRE is effective in reducing chronic low back pain and improving functional status. No study has been found examining the effect of PRE on postoperative pain and disability in patients undergoing lumbar surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercises Group | Experimental | Other: Progressive Muscle Relaxation ExercisesPatients will be taught Progressive Muscle Relaxation Exercises before the surgery and will be applied twice a week for 2 months after the surgery. |
| Control Group | No intervention | –Patients in the control group will receive standard care that includes all medical and non-medical treatments in the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having undergone spinal surgery (such as Discectomy, Laminectomy, Spinal fusion, Foraminatomy),
- 18 years of age or older
- Agreeing to apply progressive relaxation exercises and willing and willing to participate in the study,
- Having no medically diagnosed health problems (neurological, psychiatric, orthopedic) that will prevent learning and practicing progressive muscle relaxation exercises,
- Patients who do not know and practice progressive relaxation exercises before will be included in the study.
Key exclusion criteria (4 listed)
- Patients who will undergo emergency surgery,
- Do not want to apply progressive relaxation exercises,
- Do not apply them as desired during the working process,
- Those have health problems (neurological, psychiatric, orthopedic) that may affect their ability to do the exercises
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 Muscle Relaxation ExercisesIt is among the relaxation techniques that require the active participation of the individual. | Other | Exercises Group |
Primary outcome
Progressive Muscle Relaxation Exercises
Time frame: 12 months
Visual Analogue Scale scores will decrease after progressive muscle relaxation exercises. The highest score that can be obtained from the visual analog scale is 10 and the lowest 0. As the higher score is obtained, the patient's pain will increase, and the result is evaluated as bad.
Progressive Muscle Relaxation Exercises
Time frame: 12 months
Roland-Morris Disability Questionnaire will decrease after progressive muscle relaxation exercises.There will be a total score between 0-24. A high score indicates severe disability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 24965313Akmese ZB, Oran NT. Effects of Progressive Muscle Relaxation Exercises Accompanied by Music on Low Back Pain and Quality of Life During Pregnancy. J Midwifery Womens Health. 2014 Sep-Oct;59(5):503-9. doi: 10.1111/jmwh.12176. Epub 2014 Jun 25.
- Background: PubMed 25685400Atya AM. The validity of spinal mobility for prediction of functional disability in male patients with low back pain. J Adv Res. 2013 Jan;4(1):43-9. doi: 10.1016/j.jare.2012.01.002. Epub 2012 Feb 16.
- Background: PubMed 27120496Casser HR, Seddigh S, Rauschmann M. Acute Lumbar Back Pain. Dtsch Arztebl Int. 2016 Apr 1;113(13):223-34. doi: 10.3238/arztebl.2016.0223.
- Background: PubMed 20728065Chen YL, Francis AJ. Relaxation and imagery for chronic, nonmalignant pain: effects on pain symptoms, quality of life, and mental health. Pain Manag Nurs. 2010 Sep;11(3):159-68. doi: 10.1016/j.pmn.2009.05.005. Epub 2009 Sep 8.
- Background: PubMed 26850172Fekete TF, Haschtmann D, Kleinstuck FS, Porchet F, Jeszenszky D, Mannion AF. What level of pain are patients happy to live with after surgery for lumbar degenerative disorders? Spine J. 2016 Apr;16(4 Suppl):S12-8. doi: 10.1016/j.spinee.2016.01.180. Epub 2016 Feb 2.
- Background: PubMed 16426878Hasenbring MI, Plaas H, Fischbein B, Willburger R. The relationship between activity and pain in patients 6 months after lumbar disc surgery: do pain-related coping modes act as moderator variables? Eur J Pain. 2006 Nov;10(8):701-9. doi: 10.1016/j.ejpain.2005.11.004. Epub 2006 Jan 19.
- Background: PubMed 11740366Kucukdeveci AA, Tennant A, Elhan AH, Niyazoglu H. Validation of the Turkish version of the Roland-Morris Disability Questionnaire for use in low back pain. Spine (Phila Pa 1976). 2001 Dec 15;26(24):2738-43. doi: 10.1097/00007632-200112150-00024.
- Background: PubMed 23762355Lauche R, Materdey S, Cramer H, Haller H, Stange R, Dobos G, Rampp T. Effectiveness of home-based cupping massage compared to progressive muscle relaxation in patients with chronic neck pain--a randomized controlled trial. PLoS One. 2013 Jun 7;8(6):e65378. doi: 10.1371/journal.pone.0065378. Print 2013.
- Background: PubMed 27740397Lee CS, Kang KC, Chung SS, Park WH, Shin WJ, Seo YG. How does back muscle strength change after posterior lumbar interbody fusion? J Neurosurg Spine. 2017 Feb;26(2):163-170. doi: 10.3171/2016.7.SPINE151132. Epub 2016 Oct 14.
- Background: PubMed 27022672Mancuso CA, Reid MC, Duculan R, Girardi FP. Improvement in Pain After Lumbar Spine Surgery: The Role of Preoperative Expectations of Pain Relief. Clin J Pain. 2017 Feb;33(2):93-98. doi: 10.1097/AJP.0000000000000383.
- Background: PubMed 19319578Mannion AF, Porchet F, Kleinstuck FS, Lattig F, Jeszenszky D, Bartanusz V, Dvorak J, Grob D. The quality of spine surgery from the patient's perspective. Part 1: the Core Outcome Measures Index in clinical practice. Eur Spine J. 2009 Aug;18 Suppl 3(Suppl 3):367-73. doi: 10.1007/s00586-009-0942-8. Epub 2009 Mar 25.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will be shared with other researchers by holding a meeting after the data collection is completed.
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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.
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 Muscle Relaxation Exercises in people with Spinal Stenosis Lumbar, run by Istanbul Medeniyet 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 4 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: looking for participants now, as of the sponsor's last update on 19 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eda Polat, MSc (+905415660731, edda_akyol@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progressive Muscle Relaxation Exercises (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05253326, which also lists 11 linked publications.
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 Nov 2024.