- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07328685
Basic Body Awareness Therapy in Individuals With Migraine
May 20, 2026 updated by: Yasemin KARAASLAN, Mustafa Kemal University
Examining the Effectiveness of Basic Body Awareness Therapy in Individuals With Migraine
One biopsychosocial approach proven effective in headache treatment is basic body awareness therapy.
This study was planned to evaluate the effectiveness of basic body awareness training and lifestyle recommendations in individuals diagnosed with migraine.
Functional status will be assessed using the Migraine-Related Disability Assessment Scale (MIDAS), sleep quality using the Jenkins Sleep Scale (JUS), and quality of life using the Headache Impact Test.
Assessment of functional status, sleep quality, and quality of life will be performed before treatment and after treatment (at the end of week 8).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
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 Contact
- Name: Yasemin Karaaslan, PhD
- Phone Number: 0535 845 96 25
- Email: ptyasemindeveci@gmail.com
Study Locations
-
-
Hatay
-
Antakya, Hatay, Turkey (Türkiye), 31060
- Recruiting
- Hatay Mustafa Kemal University
-
Contact:
- Yasemin Karaaslan
- Email: ptyasemindeveci@gmail.com
-
-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosed with migraine,
- Experiencing at least 3 migraine attacks per month,
- Between the ages of 18 and 55 and who volunteer to participate in the study.
Exclusion Criteria:
- History of secondary headaches,
- Being pregnant,
- Having any other neurological disease besides migraine,
- Having other secondary headaches in addition to migraine,
- History of malignancy,
- Regularly practicing meditation, yoga, or mindfulness-based practices.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Body Awareness Therapy Plus Standard Treatment
Participants in this group will receive body awareness therapy in addition to standard treatment.
The exercise program will be implemented twice over an eight-week period.
|
Participants will receive body awareness therapy.
The program will be administered over an eight-week period and will include exercises appropriate for the study population.
Standard treatment will be in the form of individual information sessions lasting approximately 30 minutes for both groups.
Brochures will be created for distribution to individuals.
|
|
Active Comparator: Standart Treatment
Participants in this group will receive standard treatment without the additional body awareness therapy.
|
Standard treatment will be in the form of individual information sessions lasting approximately 30 minutes for both groups.
Brochures will be created for distribution to individuals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Diary
Time Frame: Individuals will be asked to regularly complete a pain diary during the 4-week period before the program, during the program, and during the 4-week follow-up period after the training is completed.
|
The severity, duration, and frequency of headaches during attacks will be recorded daily by the participants.
|
Individuals will be asked to regularly complete a pain diary during the 4-week period before the program, during the program, and during the 4-week follow-up period after the training is completed.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional status
Time Frame: Baseline and at the end of the 8-week intervention
|
The Migraine Disability Assessment Scale will be used to determine the functional status associated with migraine.
|
Baseline and at the end of the 8-week intervention
|
|
Sleep quality
Time Frame: Baseline and at the end of the 8-week intervention
|
Individuals' sleep quality will be assessed using the Jenkins Sleep Scale.
|
Baseline and at the end of the 8-week intervention
|
|
Quality of life related to headaches.
Time Frame: Baseline and at the end of the 8-week intervention
|
The Headache Impact Test will be used to assess the impact of headache on quality of life.
|
Baseline and at the end of the 8-week intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 2, 2026
Primary Completion (Actual)
March 20, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
December 27, 2025
First Submitted That Met QC Criteria
December 27, 2025
First Posted (Actual)
January 9, 2026
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 20, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMKU-BBAT-2026
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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