Education on Migraine in Pregnant Women (MIGREMB)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine Disorders
• Intervention / Treatment: Other: educational program

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronica V Olavarria, MD, MSC; Phone Number: +56977665636; Email: volavarria@alemana.cl
• Study Contact Backup: Name: Veronica V Olavarria, MD; Phone Number: +569-77665636; Email: veroolavarria@yahoo.com

Study Locations

• Chile
  • Region Metropolitana
    • Santiago, Region Metropolitana, Chile
      • Clinica Alemana de Santiago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	8 to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Collaborators and Investigators

• Sponsor: Clinica Alemana de Santiago
• Investigators: Principal Investigator: Veronica V Olavarria, MD, MSC, Clinica Alemana de Santiago

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: pregnancy; migraine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: MIGREMB Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No