Migraine DisordersMIGREMBNCT06054399
Education on Migraine in Pregnant Women
A study testing educational program in people with Migraine Disorders, run by Clinica Alemana de Santiago at 1 site in Chile.
Trial summary
Patient education is one type of low-cost intervention that can be easily applied but there are not specific studies about it in pregnant women with migraine. The primary goal of the study is to educate pregnant women experiencing migraine, leading to their understanding of the underlying pathology, management… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- educational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChile
- Study dates
- 1 Dec 2023to 30 Nov 2025
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women 18 years or older with migraine according to clinical criteria
- Informed Consent signed
- Controlled during its pregnancy at Clínica Alemana de Santiago
Who cannot join
- Any impossibility to complete the follow-up during postpartum period.
- Language barriers that would impede the patient to understand the applied questionnaires and educational interventions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Education Project on Migraine in Pregnant Women Attended at Clínica Alemana de Santiago, Chile
Patient education is one type of low-cost intervention that can be easily applied but there are not specific studies about it in pregnant women with migraine.
The primary goal of the study is to educate pregnant women experiencing migraine, leading to their understanding of the underlying pathology, management strategies and alarm symptoms.
Read more
An intervention based on education can lead to empowered individuals capable of self-management, therefore reducing medication overuse and inappropriate use of the emergency department.
It is relevant that these patients have access to understandable information; that is, in their own language and avoiding complex medical terms, so that the information can be useful for them and their support system.
With this project the investigators aimed to improve the knowledge and satisfaction of participants (patients and healthcare professionals) to better deal with migraines during pregnancy.
Read the detailed description
The primary aim of the study is to educate pregnant women experiencing migraine, leading to their understanding of the underlying pathology, management strategies and alarm symptoms.
The target population are pregnant women suffering from migraine in prenatal follow-up in Clínica Alemana (Santiago, Chile). Included as a secondary target population are the obstetricians following these patients. The investigators propose to design an educational intervention. The investigators will develop education material about migraine in Spanish and the study team will work using social media and some basic material on paper. The investigators will educate first obstetricians of the institution (Clínica Alemana de Santiago) and will work with the obstetricians in the recruitment of patients (according to International Classification of Headache Diseases-3 (ICHD-3) criteria. Secondly, among patients who consent, three educational interventions will be apply along their pregnancy, considering topics like the knowledge of migraine criteria, management strategies and alarm symptoms.
In this project two scores will be measured in pregnant women, both at their first prenatal appointment and at the end of their postpartum period (up to 42 days postpartum). These are: Migraine Disability Assessment questionnaire, and the Brief Illness Perception questionnaire, to evaluate cognitive and emotional representation of illness. Among obstetricians, the investigators will prepare and deliver a short questionnaire with dichotomous questions to evaluate their sense of knowledge regarding migraine, the satisfaction with the study and the importance the obstetricians give to the newly acquired information on daily practice.
The project will last 2 years in total, of which patients will be recruited for 18 months.
- Conditions
- Migraine Disorders
- Being tested
- educational program
- Keywords
- migraine, pregnancy
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational programOther
Education resources in Spanish through social media directed to the targeted audience mentioned above. There will be at least three interventions along the study, one for each pregnancy trimester, including topics such as: Migraine criteria, management strategies, risks of medication overuse, alarm symptoms, etc. These educational interventions will be conducted by trained health care professionals, mainly using audio-visual media.
| Study group | Role | What they receive |
|---|---|---|
| Audiovisual educational intervention | Experimental | Audiovisual educational intervention will be apply within 3 moments of the pregnancy pf patients. Receives: Other: educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Migraine Disability Assessment questionnaire score
The Migraine Disability Assessment questionnaire will be apply to patients, both at their first prenatal appointment and at the end of their postpartum period (up to 42 days postpartum), to evaluate the level of pain and the impact of headache on their daily life.The questionnaire comprises 7 questions in total and the score ranges between 0 to 90, higher scores mean higher grade of disability.
Measured: 8 to 9 months
Improvement in Brief Illness Perception questionnaire score
Both at their first prenatal appointment and at the end of their postpartum period (up to 42 days postpartum), the Brief Illness Perception questionnaire, to evaluate cognitive and emotional representation of illness.This questionnaire comprises 8 items and the score ranges from 0 to 80, a higher score indicates a greater perceived psychological burden of illness.
Measured: 8 to 9 months
Secondary outcomes (1)
Obstetricians Assessment
A survey will be delivered with dichotomous questions to evaluate their sense of knowledge regarding migraine, their satisfaction with the study and the importance they give to the newly acquired information on their daily practice.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start1 Dec 2023 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- before and after quasi experimental
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Alemana de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronica Olavarria, Clinica Alemana de Santiago
- Investigators
- Veronica V Olavarria, MD, MSC, Principal investigator, Clinica Alemana de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054399
- Sponsor's protocol ID
- MIGREMB Study
- Acronym
- MIGREMB
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education Project on Migraine in Pregnant Women Attended at Clínica Alemana de Santiago, Chile
- ClinicalTrials.gov ID
- NCT06054399
- Acronym / sponsor ID
- MIGREMB / MIGREMB Study
- Conditions
- Migraine Disorders
- Keywords
- migraine, pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Clinica Alemana de SantiagoUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 26 Sep 2023 (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.
Patient education is one type of low-cost intervention that can be easily applied but there are not specific studies about it in pregnant women with migraine.
The primary goal of the study is to educate pregnant women experiencing migraine, leading to their understanding of the underlying pathology, management strategies and alarm symptoms.
An intervention based on education can lead to empowered individuals capable of self-management, therefore reducing medication overuse and inappropriate use of the emergency department.
It is relevant that these patients have access to understandable information; that is, in their own language and avoiding complex medical terms, so that the information can be useful for them and their support system.
With this project the investigators aimed to improve the knowledge and satisfaction of participants (patients and healthcare professionals) to better deal with migraines during pregnancy.
Detailed description
The primary aim of the study is to educate pregnant women experiencing migraine, leading to their understanding of the underlying pathology, management strategies and alarm symptoms.
The target population are pregnant women suffering from migraine in prenatal follow-up in Clínica Alemana (Santiago, Chile). Included as a secondary target population are the obstetricians following these patients. The investigators propose to design an educational intervention. The investigators will develop education material about migraine in Spanish and the study team will work using social media and some basic material on paper. The investigators will educate first obstetricians of the institution (Clínica Alemana de Santiago) and will work with the obstetricians in the recruitment of patients (according to International Classification of Headache Diseases-3 (ICHD-3) criteria. Secondly, among patients who consent, three educational interventions will be apply along their pregnancy, considering topics like the knowledge of migraine criteria, management strategies and alarm symptoms.
In this project two scores will be measured in pregnant women, both at their first prenatal appointment and at the end of their postpartum period (up to 42 days postpartum). These are: Migraine Disability Assessment questionnaire, and the Brief Illness Perception questionnaire, to evaluate cognitive and emotional representation of illness. Among obstetricians, the investigators will prepare and deliver a short questionnaire with dichotomous questions to evaluate their sense of knowledge regarding migraine, the satisfaction with the study and the importance the obstetricians give to the newly acquired information on daily practice.
The project will last 2 years in total, of which patients will be recruited for 18 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before and after quasi experimental
| Arm | Type | Receives |
|---|---|---|
| Audiovisual educational intervention | Experimental | Other: educational programAudiovisual educational intervention will be apply within 3 moments of the pregnancy pf patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women 18 years or older with migraine according to clinical criteria
- Informed Consent signed
- Controlled during its pregnancy at Clínica Alemana de Santiago
Key exclusion criteria (2 listed)
- Any impossibility to complete the follow-up during postpartum period.
- Language barriers that would impede the patient to understand the applied questionnaires and educational interventions
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 |
|---|---|---|
| educational programEducation resources in Spanish through social media directed to the targeted audience mentioned above. There will be at least three interventions along the study, one for each pregnancy trimester, including topics such as: Migraine criteria, management strategies, risks of medication overuse, alarm symptoms, etc. These educational interventions will be conducted by trained health care professionals, mainly using audio-visual media. | Other | Audiovisual educational intervention |
Primary outcome
Improvement in Migraine Disability Assessment questionnaire score
Time frame: 8 to 9 months
The Migraine Disability Assessment questionnaire will be apply to patients, both at their first prenatal appointment and at the end of their postpartum period (up to 42 days postpartum), to evaluate the level of pain and the impact of headache on their daily life.The questionnaire comprises 7 questions in total and the score ranges between 0 to 90, higher scores mean higher grade of disability.
Improvement in Brief Illness Perception questionnaire score
Time frame: 8 to 9 months
Both at their first prenatal appointment and at the end of their postpartum period (up to 42 days postpartum), the Brief Illness Perception questionnaire, to evaluate cognitive and emotional representation of illness.This questionnaire comprises 8 items and the score ranges from 0 to 80, a higher score indicates a greater perceived psychological burden of illness.
1 secondary outcome
Obstetricians Assessment
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Veronica V Olavarria, MD, MSC principal investigator
Clinica Alemana de Santiago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational program in people with Migraine Disorders, run by Clinica Alemana de Santiago at 1 site in Chile.
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 3 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 28 Sep 2023. 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 Chile. 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. 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?
Contact Veronica V Olavarria, MD, MSC (+56977665636, volavarria@alemana.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Migraine Disability Assessment questionnaire score (time frame: 8 to 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2023.