Clinical trial NCT06054399: Education on Migraine in Pregnant Women
Official title: Education Project on Migraine in Pregnant Women Attended at Clínica Alemana de Santiago, Chile
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine Disorders
Keywords: migraine
pregnancy
Lead sponsor: Clinica Alemana de Santiago
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: before and after quasi experimental
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Improvement in Migraine Disability Assessment questionnaire score
timeFrame: 8 to 9 months
measure: Improvement in Brief Illness Perception questionnaire score
timeFrame: 8 to 9 months
Secondary outcomes:
measure: Obstetricians Assessment
timeFrame: 9 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clinica Alemana de Santiago
state: Region Metropolitana
Study officials:
affiliation: Clinica Alemana de Santiago
name: Veronica V Olavarria, MD, MSC
role: PRINCIPAL_INVESTIGATOR
References: