Pain, ChronicNCT06050382
Progressive Relaxation Training Effect On Pain, Activity And Social Participation In Women With Tension-Type Headache And Migraine
A study testing PROGRESSIVE RELAXATION TRAINING in people with Pain, Chronic and Migraine Disorders, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study was to investigate and compare the effects of PRT on pain characteristics, attack frequency, activity self-efficacy perception, and social participation in women with two different types of headaches, TTH and migraine. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Pain, Chronic, Migraine Disorders, Tension-Type Headache
- What is being tested?
- PROGRESSIVE RELAXATION TRAINING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Nov 2022to 10 Jul 2024
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- the ages of 20 and 45,
- having a diagnosis of TTH or migraine according to the International Classification of Headache Disorders (ICHD-II)(1), and
- expressing voluntary willingness to participate in this study.
Who cannot join
- having any pathology involving the cervical region such as disc herniation, radiculopathy, a history of surgery, tumor, or cyst,
- having received any form of physical therapy targeting the cervical region within the past 3 months,
- being pregnant or in the menopausal phase; not participating in at least 15% of the training sessions,
- having a mental disorder (being diagnosed with depression or using antidepressant medication),
- having a chronic, neurological, or rheumatic disorder; suffering from sinusitis, and being on continuous prophylactic medication for migraines
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, 06100
Gokcen Akyurek, Assoc Prof, 905426136228, gkcnakyrk@gmail.com
About this study
Official title: Investigation Of The Effect Of Progressive Relaxation Training On Pain Characteristics, Attack Frequency, Perception Of Activity Self-Efficiency And Social Participation In Women With Tension-Type Headache And Migraine
Objective: The aim of this study was to investigate and compare the effects of PRT on pain characteristics, attack frequency, activity self-efficacy perception, and social participation in women with two different types of headaches, TTH and migraine.
Methods: A total of 58 women within the age range of 20 to 45 were screened for eligibility in terms of suitability for participation in the study. Two separate progressive relaxation training sessions were administered to two distinct groups: one comprised of women with TTH and the other consisting of women with migraine. Pre- and post-training assessments were conducted for both groups as follows. Both intervention groups were instructed and trained by a physiotherapist 2times a week for 30 minutes each over 6 weeks,
Read the detailed description
The International Headache Society (IHS) reported that approximately 90% of headaches consist of tension-type headache (TTH) and migraine, which are the primary type of headache, and affect approximately 50% of the population. The incidence of headaches and migraines is to peak at the age of 20-50, and is more common in women than in men. Recurrent tension-type headaches and migraine attacks negatively affect the quality of life of individuals, reducing working capacity and participation in social and family activities. Therefore, tension-type headaches and migraines cause significant social exclusion, loss of workforce and economic burden.
TTH and migraine impede personal care, productivity and leisure activities, which are an integral part of individuals' lives due to symptoms such as pain, fatigue, difficulty concentrating and/or dizziness. Participation in purposeful activities for individuals is an essential component of health and well-being. Activity self-efficiency is a definition that includes the sense of personal competence and satisfaction about the activities women engage in. When individuals engage in work, play, and daily life activities, women sustain, reinforce, shape, and modify women's capacities, beliefs, and tendencies. High self-efficiency perception can affect the sustainability of physical activity and the productivity of individuals. Both TTH and Migraine tend to occur during the most productive and high-capacity phase of life, between ages 25-55, affecting muscle groups used in daily life activities, potentially leading to limitations in participation, coping, and self-management skills among women. In this regard, it is important to study how tension-type headaches and migraines, which have significant social and individual effects, alter the self-sufficiency and perception of activity in women. Constant thinking of pain and avoiding physical activity can reveal dysfunction in individuals. Because of the individual-specific and complex structure of human roles, each individual suffering from a headache faces different limitations in fulfilling daily roles and social participation, depending on lifestyle and preferences. Thus, non-pharmacological treatments (physiotherapy practices, lifestyle changes, cognitive behavioral therapy, body awareness therapy) are recommended for women with TTH and migraine complaints to relax various muscle groups. One of these treatments is progressive relaxation training. PRT is defined as a method of voluntary, regular relaxation of large muscle groups in the human body with relaxation throughout the body. Specifically, applying PRT to muscle groups found in hands, arms, neck, shoulders, face, chest, abdomen, hips, feet, and fingers, which are most frequently utilized in daily life activities, enhances its benefits for individuals. In the literature, various studies reported that PRT improved occupational performance, participation in daily life activities and quality of life in addition to pain management in individuals with various chronic pains. According to the knowledge, there exists no study in the literature comparing the beneficial effects that PRT, one of the optimal treatments that can be applied in women with TTH or migraine, can have on these two distinct headache groups. Furthermore, studies examining the impact of PRT on activity self-efficacy perception and social participation are quite limited. The aim of this study is to investigate and compare the effects of PRT on pain characteristics, attack frequency, activity self-efficacy perception, and social participation in women with two different types of headaches, TTH and migraine. This study will enable clinicians working with women suffering from TTH and migraine to comprehensively evaluate them in clinical settings and provide more comprehensive intervention approaches to address challenges encountered in daily life.
- Conditions
- Pain, Chronic, Migraine Disorders, Tension-Type Headache
- Being tested
- PROGRESSIVE RELAXATION TRAINING
- Keywords
- pain, women, progressive relaxation training, participation
- Medical subject headings
- Chronic Pain, Migraine Disorders, Tension-Type Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROGRESSIVE RELAXATION TRAININGOther
Both intervention groups were instructed and trained by a physiotherapist 2times a week for 30 minutes each over 6 weeks, The sessions were held in a well-lit, clean and comfortable room with a temperature of 22-24 degrees. Women were asked to stop eating and wear comfortable clothes at least two hours before the sessions. Before the training, relaxation exercises and breathing techniques explained to the women.
The women lied in the supine position firstly. Then the therapist instructed them to contract and release different muscle groups. They practiced tensing a muscle group until they felt the slight contraction and then released it, simultaneously relaxing other muscle groups. During the session, women were instructed to contract the muscles for 10-20 seconds during deep diaphragmatic breathing and to relax for 30-40 seconds while exhaling.
| Study group | Role | What they receive |
|---|---|---|
| WOMEN WITH TENSION-TYPE HEADACHE | Experimental | The tension headache group consists of 22 women aged 20-45 years.The inclusion criteria were determined as follows being between the ages of 20 and 45, having a diagnosis of TTH or migraine according to the International Classification of Headache Disorders (ICHD-II)(1), and expressing voluntary willingness to participate in this study.
The exclusion criteria for the study included having any pathology involving the cervical region such as disc herniation, radiculopathy, a history of surgery, tumor, or cyst, having received any form of physical therapy targeting the cervical region within the past 3 months, being pregnant or in the menopausal phase; not participating in at least 15% of the training sessions, having a mental disorder (being diagnosed with depression or using antidepressant medication), having a chronic, neurological, or rheumatic disorder; suffering from sinusitis, and being on continuous prophylactic medication for migraines Receives: Other: PROGRESSIVE RELAXATION TRAINING |
| WOMEN WITH MIGRAINE | Experimental | The Migraine group consists of 22 women aged 20-45 years.The inclusion criteria were determined as follows being between the ages of 20 and 45, having a diagnosis of TTH or migraine according to the International Classification of Headache Disorders (ICHD-II)(1), and expressing voluntary willingness to participate in this study.
The exclusion criteria for the study included having any pathology involving the cervical region such as disc herniation, radiculopathy, a history of surgery, tumor, or cyst, having received any form of physical therapy targeting the cervical region within the past 3 months, being pregnant or in the menopausal phase; not participating in at least 15% of the training sessions, having a mental disorder (being diagnosed with depression or using antidepressant medication), having a chronic, neurological, or rheumatic disorder; suffering from sinusitis, and being on continuous prophylactic medication for migraines Receives: Other: PROGRESSIVE RELAXATION TRAINING |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupational Self-Assessment (OSA):
OSA is a self-reported, client-centered evaluation tool based on MOHO, which assesses the degree of self-awareness and importance of the occupation by measuring the client's ability and value in performing routine occupation. It is a 4-point Likert-type scale consisting of 21 questions and 3 sections.
Measured: up to 5 months
World Health Organization Disability Assessment Schedule 2 (WHO-DAS II)
WHO-DAS II a 36-item general disability instrument that examines difficulties in six domains (activity limitations, communicating ,physical mobility, self-care participation in society, interpersonal interactions, domestic responsibilities and work of life during) in the last 30 days. Responses are given on a 5-point Likert-type scale from 1 (none) to 5 (extreme/cannot do).
Measured: up to 5 months
Pain Catastrophizing Scale (PCS):
The PCS is a 13-item questionnaire comprising three factors, rumination, magnification, and helplessness. Items are scored with a 5-point scale from 0 (not at all) to 4 (all the time). Total score ranges from 0 to 52 (27,28). High scores indicate a high level of catastrophizing.
Measured: up to 5 months
Headache Impact Test-6:
HIT-6, is a 6-item self-administered questionnaire. Items assess headache impact on lost time at work, school or social activities, pain severity, fatigue, frustration, and difficulty with concentration (21,22). Cut scores indicate the following categories: grade 1 (no effect if the scale score is ≤49), grade 2 (50-55 some impact), grade 3 (56-59 substantial impact), grade 4 (≥60 as a severe impact).
Measured: up to 5 months
Visual Analog Scale (VAS):
Pain intensity was assessed with a 10-cm visual analogue scale (VAS). The VAS is scored on a 10- cm horizontal line with indicating 0 'no pain' and 10 'unbearable pain'. The women were asked to mark their headache pain on the horizontal line. (18).
Measured: up to 5 months
Secondary outcomes (1)
Migraine Disability Assessment Scale (MIDAS):
MIDAS is a questionnaire designed to assess disability due to migraine in relation to work, household chores, and family, social or recreational activities over a three-month period (19,20). The MIDAS score is derived from responses reflecting the number of days missed due to headache and the occurrence of days with a 50% reduction in performance
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start8 Nov 2022
- Primary completion10 May 2024 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokcen Akyurek, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050382
- Sponsor's protocol ID
- 08.11.2022/3
- Status last verified
- Sep 2023
- First submitted
- 18 Aug 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available on request from the corresponding author, (gkcnakyrk@gmail.com).
Publications
Karakus A, Uzelpasaci E, Akyurek G. The comparative effectiveness of progressive relaxation training on pain characteristics, attack frequency, activity self-efficacy, and pain-related disability in women with episodic tension-type headache and migraine. PLoS One. 2025 Apr 28;20(4):e0320575. doi: 10.1371/journal.pone.0320575. eCollection 2025.
PubMed 40293994
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Of The Effect Of Progressive Relaxation Training On Pain Characteristics, Attack Frequency, Perception Of Activity Self-Efficiency And Social Participation In Women With Tension-Type Headache And Migraine
- ClinicalTrials.gov ID
- NCT06050382
- Acronym / sponsor ID
- 08.11.2022/3
- Conditions
- Pain, Chronic, Migraine Disorders, Tension-Type Headache
- Keywords
- pain, women, progressive relaxation training, participation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 10 May 2024 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 22 Sep 2023 (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.
Objective: The aim of this study was to investigate and compare the effects of PRT on pain characteristics, attack frequency, activity self-efficacy perception, and social participation in women with two different types of headaches, TTH and migraine.
Methods: A total of 58 women within the age range of 20 to 45 were screened for eligibility in terms of suitability for participation in the study. Two separate progressive relaxation training sessions were administered to two distinct groups: one comprised of women with TTH and the other consisting of women with migraine. Pre- and post-training assessments were conducted for both groups as follows. Both intervention groups were instructed and trained by a physiotherapist 2times a week for 30 minutes each over 6 weeks,
Detailed description
The International Headache Society (IHS) reported that approximately 90% of headaches consist of tension-type headache (TTH) and migraine, which are the primary type of headache, and affect approximately 50% of the population. The incidence of headaches and migraines is to peak at the age of 20-50, and is more common in women than in men. Recurrent tension-type headaches and migraine attacks negatively affect the quality of life of individuals, reducing working capacity and participation in social and family activities. Therefore, tension-type headaches and migraines cause significant social exclusion, loss of workforce and economic burden.
TTH and migraine impede personal care, productivity and leisure activities, which are an integral part of individuals' lives due to symptoms such as pain, fatigue, difficulty concentrating and/or dizziness. Participation in purposeful activities for individuals is an essential component of health and well-being. Activity self-efficiency is a definition that includes the sense of personal competence and satisfaction about the activities women engage in. When individuals engage in work, play, and daily life activities, women sustain, reinforce, shape, and modify women's capacities, beliefs, and tendencies. High self-efficiency perception can affect the sustainability of physical activity and the productivity of individuals. Both TTH and Migraine tend to occur during the most productive and high-capacity phase of life, between ages 25-55, affecting muscle groups used in daily life activities, potentially leading to limitations in participation, coping, and self-management skills among women. In this regard, it is important to study how tension-type headaches and migraines, which have significant social and individual effects, alter the self-sufficiency and perception of activity in women. Constant thinking of pain and avoiding physical activity can reveal dysfunction in individuals. Because of the individual-specific and complex structure of human roles, each individual suffering from a headache faces different limitations in fulfilling daily roles and social participation, depending on lifestyle and preferences. Thus, non-pharmacological treatments (physiotherapy practices, lifestyle changes, cognitive behavioral therapy, body awareness therapy) are recommended for women with TTH and migraine complaints to relax various muscle groups. One of these treatments is progressive relaxation training. PRT is defined as a method of voluntary, regular relaxation of large muscle groups in the human body with relaxation throughout the body. Specifically, applying PRT to muscle groups found in hands, arms, neck, shoulders, face, chest, abdomen, hips, feet, and fingers, which are most frequently utilized in daily life activities, enhances its benefits for individuals. In the literature, various studies reported that PRT improved occupational performance, participation in daily life activities and quality of life in addition to pain management in individuals with various chronic pains. According to the knowledge, there exists no study in the literature comparing the beneficial effects that PRT, one of the optimal treatments that can be applied in women with TTH or migraine, can have on these two distinct headache groups. Furthermore, studies examining the impact of PRT on activity self-efficacy perception and social participation are quite limited. The aim of this study is to investigate and compare the effects of PRT on pain characteristics, attack frequency, activity self-efficacy perception, and social participation in women with two different types of headaches, TTH and migraine. This study will enable clinicians working with women suffering from TTH and migraine to comprehensively evaluate them in clinical settings and provide more comprehensive intervention approaches to address challenges encountered in daily life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WOMEN WITH TENSION-TYPE HEADACHE | Experimental | Other: PROGRESSIVE RELAXATION TRAININGThe tension headache group consists of 22 women aged 20-45 years.The inclusion criteria were determined as follows being between the ages of 20 and 45, having a diagnosis of TTH or migraine according to the International Classification of Headache Disorders (ICHD-II)(1), and expressing voluntary willingness to participate in this study. The exclusion criteria for the study included having any pathology involving the cervical region such as disc herniation, radiculopathy, a history of surgery, tumor, or cyst, having received any form of physical therapy targeting the cervical region within the past 3 months, being pregnant or in the menopausal phase; not participating in at least 15% of the training sessions, having a mental disorder (being diagnosed with depression or using antidepressant medication), having a chronic, neurological, or rheumatic disorder; suffering from sinusitis, and being on continuous prophylactic medication for migraines |
| WOMEN WITH MIGRAINE | Experimental | Other: PROGRESSIVE RELAXATION TRAININGThe Migraine group consists of 22 women aged 20-45 years.The inclusion criteria were determined as follows being between the ages of 20 and 45, having a diagnosis of TTH or migraine according to the International Classification of Headache Disorders (ICHD-II)(1), and expressing voluntary willingness to participate in this study. The exclusion criteria for the study included having any pathology involving the cervical region such as disc herniation, radiculopathy, a history of surgery, tumor, or cyst, having received any form of physical therapy targeting the cervical region within the past 3 months, being pregnant or in the menopausal phase; not participating in at least 15% of the training sessions, having a mental disorder (being diagnosed with depression or using antidepressant medication), having a chronic, neurological, or rheumatic disorder; suffering from sinusitis, and being on continuous prophylactic medication for migraines |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- the ages of 20 and 45,
- having a diagnosis of TTH or migraine according to the International Classification of Headache Disorders (ICHD-II)(1), and
- expressing voluntary willingness to participate in this study.
Key exclusion criteria (5 listed)
- having any pathology involving the cervical region such as disc herniation, radiculopathy, a history of surgery, tumor, or cyst,
- having received any form of physical therapy targeting the cervical region within the past 3 months,
- being pregnant or in the menopausal phase; not participating in at least 15% of the training sessions,
- having a mental disorder (being diagnosed with depression or using antidepressant medication),
- having a chronic, neurological, or rheumatic disorder; suffering from sinusitis, and being on continuous prophylactic medication for migraines
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 TRAININGBoth intervention groups were instructed and trained by a physiotherapist 2times a week for 30 minutes each over 6 weeks, The sessions were held in a well-lit, clean and comfortable room with a temperature of 22-24 degrees. Women were asked to stop eating and wear comfortable clothes at least two hours before the sessions. Before the training, relaxation exercises and breathing techniques explained to the women. The women lied in the supine position firstly. Then the therapist instructed them to contract and release different muscle groups. They practiced tensing a muscle group until they felt the slight contraction and then released it, simultaneously relaxing other muscle groups. During the session, women were instructed to contract the muscles for 10-20 seconds during deep diaphragmatic breathing and to relax for 30-40 seconds while exhaling. | Other | WOMEN WITH MIGRAINE, WOMEN WITH TENSION-TYPE HEADACHE |
Primary outcome
Occupational Self-Assessment (OSA):
Time frame: up to 5 months
OSA is a self-reported, client-centered evaluation tool based on MOHO, which assesses the degree of self-awareness and importance of the occupation by measuring the client's ability and value in performing routine occupation. It is a 4-point Likert-type scale consisting of 21 questions and 3 sections.
World Health Organization Disability Assessment Schedule 2 (WHO-DAS II)
Time frame: up to 5 months
WHO-DAS II a 36-item general disability instrument that examines difficulties in six domains (activity limitations, communicating ,physical mobility, self-care participation in society, interpersonal interactions, domestic responsibilities and work of life during) in the last 30 days. Responses are given on a 5-point Likert-type scale from 1 (none) to 5 (extreme/cannot do).
Pain Catastrophizing Scale (PCS):
Time frame: up to 5 months
The PCS is a 13-item questionnaire comprising three factors, rumination, magnification, and helplessness. Items are scored with a 5-point scale from 0 (not at all) to 4 (all the time). Total score ranges from 0 to 52 (27,28). High scores indicate a high level of catastrophizing.
Headache Impact Test-6:
Time frame: up to 5 months
HIT-6, is a 6-item self-administered questionnaire. Items assess headache impact on lost time at work, school or social activities, pain severity, fatigue, frustration, and difficulty with concentration (21,22). Cut scores indicate the following categories: grade 1 (no effect if the scale score is ≤49), grade 2 (50-55 some impact), grade 3 (56-59 substantial impact), grade 4 (≥60 as a severe impact).
Visual Analog Scale (VAS):
Time frame: up to 5 months
Pain intensity was assessed with a 10-cm visual analogue scale (VAS). The VAS is scored on a 10- cm horizontal line with indicating 0 'no pain' and 10 'unbearable pain'. The women were asked to mark their headache pain on the horizontal line. (18).
1 secondary outcome
Migraine Disability Assessment Scale (MIDAS):
Time frame: up to 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Derived from this study: PubMed 40293994Karakus A, Uzelpasaci E, Akyurek G. The comparative effectiveness of progressive relaxation training on pain characteristics, attack frequency, activity self-efficacy, and pain-related disability in women with episodic tension-type headache and migraine. PLoS One. 2025 Apr 28;20(4):e0320575. doi: 10.1371/journal.pone.0320575. eCollection 2025.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available on request from the corresponding author, (gkcnakyrk@gmail.com).
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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.
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 TRAINING in people with Pain, Chronic and Migraine Disorders, run by Hacettepe 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 3 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: status not confirmed, as of the sponsor's last update on 22 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gokcen Akyurek, Assoc Prof (905426136228, gkcnakyrk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occupational Self-Assessment (OSA): (time frame: up to 5 months). The study lists 5 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 NCT06050382, which also lists 1 linked publication.
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 22 Sep 2023.