Migraine HeadacheNCT05039996
Effectiveness of Education and Relaxation Program on Migraine Related Disability in Patients Attending Headache Clinic
A study testing education and relaxation program in people with Migraine Headache, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- education and relaxation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to Jun 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Secondary headache.
- Patients with severe co-morbid psychiatric (depression, anxiety), personality or medical condition (liver or renal impairments).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Integrated Education and Relaxation Program on Migraine Related Disability in Patients Attending Headache Clinic, Ain Shams University Hospitals: A Randomized Controlled Trial
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.
Read the detailed description
- The participants will be assessed for their eligibility based on inclusion and exclusion criteria. After obtaining the written informed consent, the eligible participants will be randomized to either an intervention or a control group. Psychiatric and personality disorders will be excluded before participation using the translated form of (Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders) I and II questionnaires.
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 (preventive treatment with stable dose for at least 3 months and not to change the dose through the study).
For proper conduction of the study, three phases will be performed:
Assessment phase:
Each migraine patient in the intervention and control group will be interviewed individually before applying the planned program to collect socio-demographic data and clinical migraine evaluation using the clinical sheet of the clinic. Then base line measures of headache-related disability and migraine specific quality of life using migraine specific quality of life questionnaire before any intervention. Retrospective recording of 1 month past migraine attacks frequency will be recorded. This interview will take about 25-30 minutes.
Implementation phase:
- intervention group An intervention program will be implemented to the intervention group only after dividing them into small homogeneous groups. The program will be conducted in the clinic, it includes two parts educational and training part.
The educational part will be done once in the first visit in about 30 minutes aiming to increase patient knowledge about migraine reduce the impact of migraine in daily life, the session will include concise messages about:
- Basic migraine education.
- Identify Common triggers to reduce and avoid migraine attacks.
- Role of non-pharmaceutical therapies.
- Steps for getting support from family, friends and at work.
- Encourage use of the headache dairy.
- How to prepare migraine emergency tool kit.
- Explanation and demonstration of progressive muscle relaxation and deep breathing training (20-30min).
Information and skills will be demonstrated and applied in the session through power point presentation, educational brochures, video lessons and guided home-based practice.
The information will be in a simple language, relevant to the disease process and management as well as evidence-based (guidelines for controlled trial in migraine, 2012).
The practical part:
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 regularly be done weekly by Telephone for the remainder of the study between educational, reinforcement and final evaluation sessions.
Participants who will return for reinforcement sessions will receive mild compensation for study participation.
The control group 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.
Evaluation phase:
Evaluation of both groups will be done using headache diary and migraine specific quality of life questionnaires. After another 4 weeks, the two groups' participants will be reevaluated. Final evaluation will be done after 3 month from base line by the researcher using the same tools.
•Statistical Analysis /Statistical Package:-
-The data will be collected, revised, coded and entered to personal computer, Statistical analysis by the appropriate statistical tests will be done using (statistical package for social science) program version 20.
- Conditions
- Migraine Headache
- Being tested
- education and relaxation program
- Keywords
- Migraine, Health Education, Relaxation Training, Disability
- Medical subject headings
- Migraine Disorders, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education and relaxation programBehavioural
Also called integrated therapeutic patient education and relaxation program
randomized controlled trial
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: education and relaxation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 month
Secondary outcomes (1)
Effectiveness of the intervention program on headache related quality of life and disability
By using the "Migraine specific quality of life questionnaire (MSQ)": The MSQ is a 14-items measure designed to assess the effects of migraine on an individual's quality of life. There are three MSQ subscales, Emotional (MSQ-E), restrictive (MSQ-R), and preventive (MSQ-P). The MSQ is a reliable and valid questionnaire in migraine patients that can determine the functional impact of migraine.
Evaluation of both groups will be done using "MSQ questionnaire" at base line and after another 4 weeks, Final evaluation will be done after 3 month from base line by the researcher using the same tool.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Mar 2020
- Primary completion13 Sep 2021
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara H Abd El Khalek, Principal investigator, Assistant lecturer ,Family medicine departmentAyat F Mohamed, Study chair, lecturer,Community, Environmental and Occupational medicineRanda M Amin, Study chair, lecturer in neurology departmentMohammed M Fouad, Study chair, Assistant professor, neurology departmentDiaa M Abd El Hamid, Study chair, Head of Family Medicine Department.Hisham A Hatata, Study chair, professor psychiatry department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039996
- Sponsor's protocol ID
- FMASU M D 231/2018
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data that underlie the results reported in this article
Publications
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.
PubMed 22384463Eghbal 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Integrated Education and Relaxation Program on Migraine Related Disability in Patients Attending Headache Clinic, Ain Shams University Hospitals: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05039996
- Acronym / sponsor ID
- FMASU M D 231/2018
- Conditions
- Migraine Headache
- Keywords
- Migraine, Health Education, Relaxation Training, Disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 10 Sep 2021 (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.
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.
Detailed description
- The participants will be assessed for their eligibility based on inclusion and exclusion criteria. After obtaining the written informed consent, the eligible participants will be randomized to either an intervention or a control group. Psychiatric and personality disorders will be excluded before participation using the translated form of (Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders) I and II questionnaires.
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 (preventive treatment with stable dose for at least 3 months and not to change the dose through the study).
For proper conduction of the study, three phases will be performed:
Assessment phase:
Each migraine patient in the intervention and control group will be interviewed individually before applying the planned program to collect socio-demographic data and clinical migraine evaluation using the clinical sheet of the clinic. Then base line measures of headache-related disability and migraine specific quality of life using migraine specific quality of life questionnaire before any intervention. Retrospective recording of 1 month past migraine attacks frequency will be recorded. This interview will take about 25-30 minutes.
Implementation phase:
- intervention group An intervention program will be implemented to the intervention group only after dividing them into small homogeneous groups. The program will be conducted in the clinic, it includes two parts educational and training part.
The educational part will be done once in the first visit in about 30 minutes aiming to increase patient knowledge about migraine reduce the impact of migraine in daily life, the session will include concise messages about:
- Basic migraine education.
- Identify Common triggers to reduce and avoid migraine attacks.
- Role of non-pharmaceutical therapies.
- Steps for getting support from family, friends and at work.
- Encourage use of the headache dairy.
- How to prepare migraine emergency tool kit.
- Explanation and demonstration of progressive muscle relaxation and deep breathing training (20-30min).
Information and skills will be demonstrated and applied in the session through power point presentation, educational brochures, video lessons and guided home-based practice.
The information will be in a simple language, relevant to the disease process and management as well as evidence-based (guidelines for controlled trial in migraine, 2012).
The practical part:
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 regularly be done weekly by Telephone for the remainder of the study between educational, reinforcement and final evaluation sessions.
Participants who will return for reinforcement sessions will receive mild compensation for study participation.
The control group 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.
Evaluation phase:
Evaluation of both groups will be done using headache diary and migraine specific quality of life questionnaires. After another 4 weeks, the two groups' participants will be reevaluated. Final evaluation will be done after 3 month from base line by the researcher using the same tools.
•Statistical Analysis /Statistical Package:-
-The data will be collected, revised, coded and entered to personal computer, Statistical analysis by the appropriate statistical tests will be done using (statistical package for social science) program version 20.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: education and relaxation programEducational 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. |
| Control group | Placebo comparator | Behavioral: education and relaxation programThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Secondary headache.
- Patients with severe co-morbid psychiatric (depression, anxiety), personality or medical condition (liver or renal impairments).
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 |
|---|---|---|
| education and relaxation programAlso: integrated therapeutic patient education and relaxation programrandomized controlled trial | Behavioural | Control group, Intervention group |
Primary outcome
Effectiveness of the intervention program on headache frequency
Time frame: 3 month
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
Effectiveness of the intervention program on headache intensity
Time frame: 3 month
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
Effectiveness of the intervention program on headache (attacks) duration
Time frame: 3 month
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
1 secondary outcome
Effectiveness of the intervention program on headache related quality of life and disability
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Background: PubMed 22384463Tfelt-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.
- BackgroundEghbal 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.
- Individual participant dataSharing planned: Yes. individual participant data that underlie the results reported in this article
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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.
Sara H Abd El Khalek principal investigator
Assistant lecturer ,Family medicine department
Ayat F Mohamed study chair
lecturer,Community, Environmental and Occupational medicine
Randa M Amin study chair
lecturer in neurology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education and relaxation program in people with Migraine Headache, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 2 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 18 Feb 2022. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the intervention program on headache frequency (time frame: 3 month). The study lists 3 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 NCT05039996, which also lists 2 linked publications.
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 18 Feb 2022.