Education on Migraine in Pregnant Women (MIGREMB)
Primary Purpose
Migraine Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
educational program
Sponsored by
About this trial
This is an interventional supportive care trial for Migraine Disorders focused on measuring migraine, pregnancy
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
Sites / Locations
- Clinica Alemana de Santiago
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Audiovisual educational intervention
Arm Description
Audiovisual educational intervention will be apply within 3 moments of the pregnancy pf patients.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT06054399
First Posted
September 5, 2023
Last Updated
September 25, 2023
Sponsor
Clinica Alemana de Santiago
1. Study Identification
Unique Protocol Identification Number
NCT06054399
Brief Title
Education on Migraine in Pregnant Women
Acronym
MIGREMB
Official Title
Education Project on Migraine in Pregnant Women Attended at Clínica Alemana de Santiago, Chile
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinica Alemana de Santiago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
migraine, pregnancy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
before and after quasi experimental
Masking
None (Open Label)
Masking Description
All the participants will know about the educational interventional as well as their physicians.
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Audiovisual educational intervention
Arm Type
Experimental
Arm Description
Audiovisual educational intervention will be apply within 3 moments of the pregnancy pf patients.
Intervention Type
Other
Intervention Name(s)
educational program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in Migraine Disability Assessment questionnaire score
Description
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.
Time Frame
8 to 9 months
Title
Improvement in Brief Illness Perception questionnaire score
Description
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.
Time Frame
8 to 9 months
Secondary Outcome Measure Information:
Title
Obstetricians Assessment
Description
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.
Time Frame
9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica V Olavarria, MD, MSC
Phone
+56977665636
Email
volavarria@alemana.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica V Olavarria, MD
Phone
+569-77665636
Ext
0
Email
veroolavarria@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica V Olavarria, MD, MSC
Organizational Affiliation
Clinica Alemana de Santiago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Alemana de Santiago
City
Santiago
State/Province
Region Metropolitana
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Education on Migraine in Pregnant Women
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