PRENAYOGA: Exploratory Feasibility Study of Bi-weekly Pregnancy Yoga-based Sessions for Ethnic Minority Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- To assess the acceptability of the intervention
研究概览
简要总结
Depression and anxiety are the most prevalent psychiatric disorders in the perinatal period. A recent report found that nearly 50% of new mothers in London (where 40% of the population is of ethnic minority background) display symptoms of postnatal depression (PND).
A 2022 report by the London School of Economics (LSE) found that treating maternal mental illness could save the National Health Service (NHS) £52 million over 10 years; in 2014, the LSE calculated that two-thirds of that cost is linked to adverse child development.
Prenatal depression results in adverse outcomes for the mother and infant, which are also linked to the impact of postnatal depression on the emotional relationship and attachment between the mother and the child. The major risk for developing depression postnatally is a history of depression, either in the lifetime or during pregnancy.
Several studies highlight that antenatal depression rates are higher in ethnic minority women. However, the percentage of ethnically diverse women in most studies on perinatal depression is negligible. Additionally, ethnic minority women are less represented in perinatal mental health therapeutic settings.
Preliminary evidence indicates prenatal yoga reduces anxiety and depression and improves mother-foetal attachment. Ethnic minorities support mind-body interventions such as yoga and may be more likely to engage in community-based activities than traditional antenatal classes.
An 8-week feasibility study will assess the feasibility and acceptability of a yoga-based intervention for ethnic minority women in London.
详细描述
This exploratory feasibility study intends to understand participants' experiences and implementation considerations of an evidence-based, stakeholder-co-designed prenatal yoga intervention.
Participants will be recruited through signposting in the community and social media. Potential participants will complete an online form store on the study-specific SharePoint where they will include their name, date of birth, due date, mobile number, e-mail address, home address, GP/midwife contact details, frequency of previous yoga practice and availability for the study. This information will allow researchers to assess for eligibility and gather contact details for baseline assessment. The ICF and PIS will be sent to participants who fulfil the eligibility criteria. If participants do not enrol on the study, their information will be deleted.
Once they agree to be part of the study and basic demographics are collected on Zoom, participants will be sent, via e-mail, questionnaires to complete (on their phones or laptops) to evaluate their mental health, social support and attachment to the baby. These questionnaires are surveys that can be answered quickly and allow researchers to quantify changes in psychological states over time. Implementation questionnaires to understand how the intervention can be tested in future large-scale studies will also be collected on REDCap. Attendance and enrolment rates will also be collected for adherence and uptake implementation measures.
Questionnaires will be again completed at week 4 (midpoint of the study), week 8 (end of study), at 8 weeks postpartum and 6 months postpartum. There will be a 2-week leeway for questionnaire completion by participants.
Salivary cortisol samples will be collected at the beginning and end of sessions 1 and 8 to assess in-person changes in cortisol outputs during the yoga sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Gestational age: week 20 of gestation or over, at the first session.
- •Over 18 years of age.
- •Basic understanding of English.
- •Able to travel to the sessions.
- •Belonging to an ethnic minority group (self-identified) other than White.
排除标准
- •Physical or mental health diagnosis that would prevent them from attending yoga sessions, as per their healthcare professional's advice (self-reported).
结局指标
主要结局
To assess the acceptability of the intervention
时间窗: End of intervention (week 8).
Total score of the Acceptability of Intervention Measure (AIM). The Acceptability of Intervention Measure (AIM) has a scale range of 1-5, with higher scores indicating greater acceptability.
次要结局
- To assess uptake/reach of the intervention(End of intervention (week 8).)
- To assess the feasibility of the intervention(End of intervention (week 8).)
- To assess the effects of quality of life(Start (baseline) and end of intervention (week 8).)
- To assess factors affecting the sustainability and scalability of the intervention(End of intervention (week 8).)
- To identify how the yoga sessions are perceived by the yoga teachers(End of intervention (week 8).)
- To assess the appropriateness of the intervention(End of intervention (week 8).)
- To assess intervention adherence and attrition rates(End of intervention (week 8).)
- To assess reasons for perceived acceptability of the intervention(End of intervention (week 8).)
- To ascertain whether yoga affects mother-infant bond (postpartum)(Start (baseline) and end of intervention (week 8).)
- To identify how the yoga sessions affect the lived experience of ethnic minority pregnant women(End of intervention (week 8).)
- To assess the effectiveness of group prenatal yoga to increase mother-foetal attachment(Start (baseline) and end of intervention (week 8).)
- To assess whether yoga improves further aspects of mental health(Start (baseline) and end of intervention (week 8).)
- To ascertain whether yoga improves social support and efficacy(Start (baseline) and end of intervention (week 8).)