Progressive Relaxation Training Effect On Pain, Activity And Social Participation In Women With Tension-Type Headache And Migraine

NCT06050382 | Unknown DMC

• 1 other identifier: 08.11.2022/3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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,

Conditions

Pain, Chronic; Migraine Disorders; Tension-Type Headache

Keywords

pain; women; progressive relaxation training; participation

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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.

  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).

  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).

  up to 5 months

Secondary Outcomes (1)

• Migraine Disability Assessment Scale (MIDAS):

  up to 5 months

Study Arms (2)

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

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

Other: PROGRESSIVE RELAXATION TRAINING

Interventions

PROGRESSIVE RELAXATION TRAINING OTHER

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.

WOMEN WITH MIGRAINE; WOMEN WITH TENSION-TYPE HEADACHE

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: The incidence of headaches and migraines is to peak at the age of 20-50, and is more common in women than in men (1,2).
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 40293994 DERIVED

MeSH Terms

Conditions

Chronic Pain; Migraine Disorders; Tension-Type Headache; Pain

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Gokcen Akyurek, Assoc Prof

CONTACT

905426136228; gkcnakyrk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: September 22, 2023
• Study Start: November 8, 2022
• Primary Completion: May 10, 2024
• Study Completion: July 10, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)