Effectiveness of Education and Relaxation Program on Migraine Related Disability in Patients Attending Headache Clinic

NCT05039996 | Unknown

• 1 other identifier: FMASU M D 231/2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Migraine causes severe impairment in quality of life (QOL) both during and between attacks. Migraine also increases absenteeism, reduces productivity at work as well as at home, disrupts social and family relationships, also is associated with increased healthcare costs. The current study aiming to evaluate the effectiveness of an integrated therapeutic patient education and relaxation training intervention in order to decrease the burden of migraine headache among adult patients attending the headache clinic in Ain Shams University Hospitals.

Conditions

Migraine Headache

Keywords

Migraine; Health Education; Relaxation Training; Disability

Outcome Measures

Primary Outcomes (3)

• Effectiveness of the intervention program on headache frequency

  Attacks frequency, expressed in days per month , will be collected from the "headache diary" filled in by the patient. Data will be recruited from the diary at base line and after another 4 weeks, Final evaluation will be done after 3 month

  3 month

• Effectiveness of the intervention program on headache intensity

  The average of monthly attacks intensity ( severity) will be measured using the (Numerical rating scale) (from 0 to 10 scales) included in the headache diary Data will be recruited from the diary at base line and after 4 weeks, Final evaluation will be done after 3 month from beginning of the intervention program

  3 month

• Effectiveness of the intervention program on headache (attacks) duration

  The average of monthly attacks duration will be calculated from the headache diary filled in by the patient at base line,4 weeks and finally after 3 month from the baseline evaluation

  3 month

Secondary Outcomes (1)

• Effectiveness of the intervention program on headache related quality of life and disability

  3 month

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Educational and training part. The educational part will be done once in the first visit in about 30 minutes Information and skills will be demonstrated and applied in the session through power point presentation, educational brochures, and video lessons and guided home-based practice. Appropriate relaxation training Program * Relaxation training comprises deep breathing exercises and progressive muscle relaxation, to perform them daily and to keep a record of them. * Group meeting sessions for training will be held every week for the 1st 4 weeks * Video programs will be used as relaxation facilitators. * Patient will try these exercises for the first time in front of the researcher. * Patients will be advised to perform them daily for 8 weeks to achieve 60 sessions and to keep a record of them. Follow up of the intervention group adherence to instructions will be done weekly by Telephone.

Behavioral: education and relaxation program

Control group

PLACEBO COMPARATOR

The control group will be advised to be adherent to the prescribed medications only and try not to change the treatment plan during the study period.

Behavioral: education and relaxation program

Interventions

education and relaxation program BEHAVIORAL

randomized controlled trial

Also known as: integrated therapeutic patient education and relaxation program

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65 years old.
• Diagnosed with migraine for at least 6 months duration.
• Experiencing 4 or more migraine days/month with disability.
• Willingness to practice relaxation exercises at home.

You may not qualify if:

• Secondary headache.
• Patients with severe co-morbid psychiatric (depression, anxiety), personality or medical condition (liver or renal impairments).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine

Cairo, 1181, Egypt

Location

Related Publications (2)

• Tfelt-Hansen P, Pascual J, Ramadan N, Dahlof C, D'Amico D, Diener HC, Hansen JM, Lanteri-Minet M, Loder E, McCrory D, Plancade S, Schwedt T; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: third edition. A guide for investigators. Cephalalgia. 2012 Jan;32(1):6-38. doi: 10.1177/0333102411417901. No abstract available.

  PMID: 22384463 BACKGROUND

• Eghbal Sekhavati, Mojtaba Rahimian Boogar, Rouhi Afkari, Somayeh Kasharafifard, Vahideh Parsaei Mehr, Fatemeh Lotfi Mola and Kobra Ahanijegar, 2016. The Study of the Effectiveness of Progressive Muscle Relaxation to Reduce Symptoms in Women with Migraine Headache. Research Journal of Medical Sciences, 10: 175-184.

  BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Health Education

Interventions

Educational Status; Relaxation Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sara H Abd El Khalek

  Assistant lecturer ,Family medicine department

  PRINCIPAL INVESTIGATOR

• Ayat F Mohamed

  lecturer,Community, Environmental and Occupational medicine

  STUDY CHAIR

• Randa M Amin

  lecturer in neurology department

  STUDY CHAIR

• Mohammed M Fouad

  Assistant professor, neurology department

  STUDY CHAIR

• Diaa M Abd El Hamid

  Head of Family Medicine Department.

  STUDY CHAIR

• Hisham A Hatata

  professor psychiatry department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants in the intervention group will receive the education and training program in addition to the routine pharmacological treatment whereas the participants in the control group will receive only the routine pharmacological treatment.

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: September 10, 2021
• Study Start: March 1, 2020
• Primary Completion: September 13, 2021
• Study Completion: June 1, 2022
• Last Updated: February 18, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: beginning 3 month and ending 7 years following article publication
• Access Criteria: proposals should be directed to the chief author

Locations

EG (1)