Department of Social Work and Social Administration, The University of Hong Kong, Pokfulam, Hong Kong SAR.
Centre on Behavioural Health, The University of Hong Kong, Pokfulam, Hong Kong SAR.
PLoS One. 2022 Jul 8;17(7):e0270683. doi: 10.1371/journal.pone.0270683. eCollection 2022.
Psychological distress is a common occurrence among women during the perinatal period. Maternal psychological distress (MPS) can also have a negative influence on neonatal outcomes such as infant health, child development or mother-child interaction. Hence, interventions to improve mental wellbeing during this period are vital. Mindfulness based intervention (MBI) has been found to be effective in reducing psychological distress. Delivery of MBI via the internet, making it accessible and inexpensive, is showing a promising positive effect in reducing psychological distress. A randomized control trial with sufficient power is required to confirm its positive effect among pregnant women. The positive effects of MBI have been found to be associated with heart rate variability (HRV) biofeedback; however, the efficacy of MBI on HRV has been rarely studied among pregnant women. Also, the potential association of HRV with MBI and psychological wellbeing needs further examination. This research aims to test the effectiveness of guided mobile-based perinatal mindfulness intervention (GMBPMI) among pregnant women experiencing psychological distress during the pre- and post-natal period, as well as examining the efficacy of GMBPMI on HRV.
This study is a randomized controlled trial that follows a parallel design. Consenting pregnant women in their second trimester (between 12th and 20th week gestation) will be randomly assigned to an intervention group (GMBPMI) or a control group (psychoeducation). The intended sample size is 198, with 99 participants in each group. Three levels of outcomes will be measured at baseline, post intervention in both the intervention and control groups, and at 36-week gestation and five-week postpartum. The primary outcomes include maternal psychological stress, mindfulness and positive appraisal HRV. Secondary outcomes are psychological and physical wellbeing. Tertiary outcomes include obstetric and neonatal outcomes, and social support. Analyses will follow an intention-to-treat method and repeated measures MANOVA will be conducted to compare changes in primary and secondary outcomes. A series of mixed-effects models will be fitted to assess the mediation effects.
This trial expects to increase understanding of GMBPMI on HRV and psychological wellbeing for pregnant women, with extended support in both pre-and post-natal periods. The study could also potentially provide evidence for delivery of cost-effective and accessible services to pregnant women.
ClinicalTrials.gov: NCT04876014, registered on 30 March 2021. Protocol Version 1.0., 10 May 2021.
围产期女性普遍存在心理困扰。产妇心理困扰（MPS）也会对新生儿结局产生负面影响，如婴儿健康、儿童发育或母婴互动。因此，在此期间改善心理健康的干预措施至关重要。基于正念的干预（MBI）已被证明可有效减轻心理困扰。通过互联网提供 MBI，使其具有可及性和低廉的价格，在减轻心理困扰方面显示出有希望的积极效果。需要一项具有足够效力的随机对照试验来证实其对孕妇的积极影响。MBI 的积极影响与心率变异性（HRV）生物反馈有关；然而，在孕妇中很少研究 MBI 对 HRV 的影响。此外，HRV 与 MBI 和心理健康之间的潜在关联需要进一步研究。本研究旨在测试在产前和产后期间经历心理困扰的孕妇中进行基于指导的移动围产期正念干预（GMBPMI）的有效性，以及研究 GMBPMI 对 HRV 的功效。
这是一项随机对照试验，采用平行设计。同意的孕妇在妊娠中期（妊娠 12 至 20 周之间）将被随机分配到干预组（GMBPMI）或对照组（心理教育）。预期样本量为 198 名，每组 99 名参与者。在基线、干预组和对照组的干预后以及 36 周妊娠和产后五周时测量三个水平的结局。主要结局包括产妇心理压力、正念和积极评价 HRV。次要结局是心理和身体健康。三级结局包括产科和新生儿结局以及社会支持。分析将遵循意向治疗方法，重复测量 MANOVA 将用于比较主要和次要结局的变化。一系列混合效应模型将用于评估中介效应。
这项试验有望增加对 GMBPMI 对孕妇 HRV 和心理健康的理解，并在产前和产后期间提供更广泛的支持。该研究还可能为向孕妇提供具有成本效益和可及性的服务提供证据。
ClinicalTrials.gov：NCT04876014，于 2021 年 3 月 30 日注册。方案版本 1.0.，2021 年 5 月 10 日。
