Sanfilippo Katie Rose M, McConnell Bonnie, Cornelius Victoria, Darboe Buba, Huma Hajara B, Gaye Malick, Ramchandani Paul, Ceesay Hassoum, Glover Vivette, Cross Ian, Stewart Lauren
1Goldsmiths, University of London, London, UK.
2The Australian National University, Canberra, Australia.
Pilot Feasibility Stud. 2019 Nov 7;5:124. doi: 10.1186/s40814-019-0515-5. eCollection 2019.
Perinatal mental health problems affect up to one in five women worldwide. Mental health problems in the perinatal period are a particular challenge in low- and middle-income countries (LMICs) where they can be at least twice as frequent as in higher-income countries. It is thus of high priority to develop new low-cost, low-resource, non-stigmatising and culturally appropriate approaches to reduce symptoms of anxiety and depression perinatally, for the benefit of both mother and child. Music-centred approaches may be particularly useful in The Gambia since a range of musical practices that specifically engage pregnant women and new mothers already exist.
This protocol is for a study to examine the feasibility of undertaking a stepped wedge trial to test how a Community Health Intervention through Musical Engagement (CHIME) could be beneficial in alleviating perinatal mental distress in The Gambia. In this study, we plan to recruit 120 pregnant women ( = 60 intervention, = 60 control) at four antenatal clinics over two 6-week stepped sequences. Women in the intervention will participate in weekly group-singing sessions, led by local Kanyeleng singing groups, for 6 weeks. The control group will receive standard care. We will assess symptoms of anxiety and depression using the Edinburgh Postnatal Depression Scale (EPDS) and the Self-Reporting Questionnaire (SRQ-20). The feasibility of the design will be assessed through recruitment, retention and attrition rates of participants, clinics' adherence to the schedule and completeness of data by site. Qualitative interviews and video and audio recordings will be used to evaluate the acceptability of the intervention.
This feasibility trial will allow us to determine whether a larger trial with the same intervention and target group is feasible and acceptable in The Gambia.
Retrospectively registered (24/01/2019) with Pan African Clinical Trials Registry (PACTR): PACTR201901917619299.
全球多达五分之一的女性受到围产期心理健康问题的影响。围产期心理健康问题在低收入和中等收入国家（LMICs）是一项特殊挑战，在这些国家，其发生率至少是高收入国家的两倍。因此，开发新的低成本、低资源、无污名化且符合文化背景的方法来减轻围产期焦虑和抑郁症状，对母婴双方都有益，这是当务之急。以音乐为中心的方法在冈比亚可能特别有用，因为一系列专门针对孕妇和新妈妈的音乐活动已经存在。
本方案是一项关于研究进行阶梯式楔形试验以测试通过音乐参与的社区健康干预（CHIME）如何有助于减轻冈比亚围产期精神痛苦的可行性的研究。在本研究中，我们计划在两个为期6周的阶梯序列中，于四个产前诊所招募120名孕妇（干预组 = 60名，对照组 = 60名）。干预组的女性将参加由当地Kanyeleng歌唱团体主导的每周一次的集体歌唱活动，为期6周。对照组将接受标准护理。我们将使用爱丁堡产后抑郁量表（EPDS）和自评问卷（SRQ - 20）评估焦虑和抑郁症状。将通过参与者的招募、留存和流失率、诊所对时间表的遵守情况以及各站点数据的完整性来评估设计的可行性。定性访谈以及视频和音频记录将用于评估干预措施的可接受性。
这项可行性试验将使我们能够确定在冈比亚对相同干预措施和目标群体进行更大规模试验是否可行且可接受。
已追溯注册（2019年1月24日）于泛非临床试验注册中心（PACTR）：PACTR201901917619299。
