NCT07328685

Brief Summary

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

January 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 27, 2025

Last Update Submit

December 27, 2025

Conditions

Migraine

Keywords

migrainefunctional statussleepquality of life

Outcome Measures

Primary Outcomes (1)

  • Pain Diary

    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 Outcomes (3)

  • Functional status

    Baseline and at the end of the 8-week intervention

  • Sleep quality

    Baseline and at the end of the 8-week intervention

  • Quality of life related to headaches.

    Baseline and at the end of the 8-week intervention

Study Arms (2)

Body Awareness Therapy Plus Standard Treatment

EXPERIMENTAL

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.

Behavioral: ExerciseBehavioral: Standart therapy

Standart Treatment

ACTIVE COMPARATOR

Participants in this group will receive standard treatment without the additional body awareness therapy.

Behavioral: Standart therapy

Interventions

ExerciseBEHAVIORAL

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.

Body Awareness Therapy Plus Standard Treatment
Standart therapyBEHAVIORAL

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.

Body Awareness Therapy Plus Standard TreatmentStandart Treatment

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Migraine Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Yasemin Karaaslan, PhD

CONTACT

0535 845 96 25ptyasemindeveci@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 27, 2025

First Posted

January 9, 2026

Study Start

January 2, 2026

Primary Completion

March 20, 2026

Study Completion

April 1, 2026

Last Updated

January 9, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share