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临床试验/NCT06054399
NCT06054399尚未招募不适用

Education Project on Migraine in Pregnant Women Attended at Clínica Alemana de Santiago, Chile

Clinica Alemana de Santiago1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Improvement in Brief Illness Perception questionnaire score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

盲法说明

All the participants will know about the educational interventional as well as their physicians.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Audiovisual educational intervention

Experimental

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

干预措施: educational program (Other)

结局指标

主要结局

Improvement in Brief Illness Perception questionnaire score

时间窗: 8 to 9 months

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.

Improvement in Migraine Disability Assessment questionnaire score

时间窗: 8 to 9 months

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.

次要结局

  • Obstetricians Assessment(9 months)

研究者

发起方
Clinica Alemana de Santiago
申办方类型
Other
责任方
Principal Investigator
主要研究者

Veronica Olavarria

Medical Doctor

Clinica Alemana de Santiago

研究点 (1)

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