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A study protocol for testing the feasibility of a randomised stepped wedge cluster design to investigate a Community Health Intervention through Musical Engagement (CHIME) for perinatal mental health in The Gambia.
Pilot and Feasibility Studies ( IF 1.5 ) Pub Date : 2019-11-07 , DOI: 10.1186/s40814-019-0515-5
Katie Rose M Sanfilippo 1 , Bonnie McConnell 2 , Victoria Cornelius 3 , Buba Darboe 4 , Hajara B Huma 4, 5 , Malick Gaye 4, 5 , Paul Ramchandani 6 , Hassoum Ceesay 5 , Vivette Glover 3 , Ian Cross 6 , Lauren Stewart 1
Affiliation  

Background 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. Methods 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 (n = 60 intervention, n = 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. Discussion 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. Trial registration Retrospectively registered (24/01/2019) with Pan African Clinical Trials Registry (PACTR): PACTR201901917619299.

中文翻译:

一项研究方案,用于测试随机阶梯楔形集群设计的可行性,以调查通过音乐参与 (CHIME) 对冈比亚围产期心理健康进行的社区健康干预。

背景 围产期心理健康问题影响全球多达五分之一的女性。围产期的心理健康问题在低收入和中等收入国家 (LMIC) 是一个特殊的挑战,这些问题的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、非污名化和文化上适当的方法来减少围产期焦虑和抑郁症状,造福母亲和孩子,是当务之急。以音乐为中心的方法在冈比亚可能特别有用,因为已经存在一系列专门吸引孕妇和新妈妈的音乐实践。方法 该协议用于研究进行阶梯楔形试验的可行性,以测试通过音乐参与 (CHIME) 进行的社区健康干预如何有助于缓解冈比亚的围产期精神困扰。在这项研究中,我们计划在两个 6 周的阶梯式序列中,在四个产前诊所招募 120 名孕妇(n = 60 干预,n = 60 控制)。参与干预的女性将参加由当地 Kanyeleng 歌唱团体领导的为期 6 周的每周集体歌唱课程。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) 和自我报告问卷 (SRQ-20) 来评估焦虑和抑郁的症状。设计的可行性将通过参与者的招募、保留和流失率来评估,诊所遵守时间表和站点数据的完整性。定性访谈和视频和音频记录将用于评估干预的可接受性。讨论 该可行性试验将使我们能够确定在冈比亚进行具有相同干预措施和目标群体的更大试验是否可行和可接受。试验注册 在泛非临床试验注册中心 (PACTR) 进行回顾性注册 (24/01/2019):PACTR201901917619299。
更新日期:2019-11-07
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