Education on Migraine in Pregnant Women

NCT ID: NCT06054399

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-11-30

Brief 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 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.

Conditions

Migraine Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Audiovisual educational intervention

Audiovisual educational intervention will be apply within 3 moments of the pregnancy pf patients.

Group Type: EXPERIMENTAL

educational program

Intervention Type: OTHER

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.

Interventions

educational program

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Pregnant women 18 years or older with migraine according to clinical criteria
• Informed Consent signed
• Controlled during its pregnancy at Clínica Alemana de Santiago

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Clinica Alemana de Santiago

OTHER

Sponsor Role: lead

Responsible Party

Veronica Olavarria

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veronica V Olavarria, MD, MSC

Role: PRINCIPAL_INVESTIGATOR

Clinica Alemana de Santiago

Locations

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, Chile

Countries

Chile

Central Contacts

Veronica V Olavarria, MD, MSC

Role: CONTACT

volavarria@alemana.cl

+56977665636

Veronica V Olavarria, MD

Role: CONTACT

veroolavarria@yahoo.com

+569-77665636 ext. 0

Other Identifiers

MIGREMB Study

Identifier Type: -

Identifier Source: org_study_id