Education on Migraine in Pregnant Women

NCT06054399 | Unknown

• 1 other identifier: MIGREMB Study
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders

Keywords

migraine; pregnancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Obstetricians Assessment

  9 months

Study Arms (1)

Audiovisual educational intervention

EXPERIMENTAL

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

Other: educational program

Interventions

educational program 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.

Audiovisual educational intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Alemana de Santiago: lead

Study Sites (1)

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Veronica V Olavarria, MD, MSC

  Clinica Alemana de Santiago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica V Olavarria, MD, MSC

CONTACT

+56977665636; volavarria@alemana.cl

Veronica V Olavarria, MD

CONTACT

+569-77665636; veroolavarria@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All the participants will know about the educational interventional as well as their physicians.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: before and after quasi experimental

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 26, 2023
• Study Start: December 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: November 30, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)