Clinical Research Directory

e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss

This study is part of the e-Perinatal project and is embedded within the parent e-Perinatal cluster randomized controlled trial (NCT07613008). No additional randomization is performed for this embedded study. Women participating in the parent trial who experience early miscarriage/early pregnancy loss, late miscarriage/second-trimester miscarriage, stillbirth, or neonatal death within the first 28 days of life, together with their participating partners, are eligible for this study. Participants retain the study-group allocation assigned to their primary healthcare center in the parent trial. Participants from clusters allocated to the intervention arm are offered access to the e-Perinatal Butterfly web-app as a complementary component of the e-Perinatal intervention. The e-Perinatal Butterfly web-app provides tailored psychoeducational resources and digital support tools for parents experiencing perinatal bereavement. Participants from clusters allocated to the control arm continue to receive usual care. The primary objectives are to assess the feasibility and acceptability of the e-Perinatal Butterfly intervention. The study will also explore changes in symptoms of depression and anxiety among parents who have experienced a perinatal loss. Secondary exploratory analyses will examine longitudinal trajectories of depression and anxiety among bereaved participants and compare these trajectories between the intervention and control arms and with those observed in the broader cohort of the parent e-Perinatal trial

An ACT-Based Family Psychosocial Intervention for Women With Perinatal Loss and Their Spouses: A Pilot Randomised Controlled Trial

This pilot randomised controlled trial evaluates the feasibility, acceptability, and preliminary effects of an Acceptance and Commitment Therapy (ACT)-based family psychosocial intervention for women requiring medically indicated induction of labour because of fetal or maternal health problems, together with their spouses as primary caregivers. The study is conducted at three tertiary hospitals in Changsha, Hunan, China. The target sample is 44 woman-spouse dyads, allocated 1:1 to usual care plus the intervention or usual care alone. The approximately 3-month intervention comprises eight sessions: four face-to-face hospital sessions lasting 30-60 minutes and four online dyadic sessions via Tencent Meeting lasting 20-45 minutes. The post-discharge online sessions (Sessions 5 to 8) are conducted within 3 days, in the second week, in the first month, and in the third month (booster session) following the patient's discharge. Outcomes are assessed at baseline before randomisation (T0) and within 1 week after intervention completion (T1), with corresponding assessment timing in the control group. Perinatal grief is the primary effectiveness outcome. Secondary outcomes include depression, anxiety, post-traumatic stress symptoms, psychological flexibility, health information literacy, mindful self-care, and perceived social support. Feasibility is assessed through recruitment, adherence, implementation, attrition, and reasons for withdrawal. Intervention-group dyads jointly complete an 17-item satisfaction questionnaire at T1 and are invited to qualitative interviews within 1 week after intervention completion.

Comparison of Social Media-Based and Online Training in Grief Counseling Education

This randomized trial aims to compare the effectiveness of two digital educational approaches for perinatal grief counseling training among midwives and nurses working in perinatal care settings in Türkiye: a social media-based education program delivered through Instagram and an online education program delivered through Zoom. Both groups will receive the same six-module perinatal grief counseling education content, but through different delivery methods. Participants will be randomly assigned to one of the two study groups. Outcomes will be assessed before the intervention, immediately after completion of the 6-week training program, and 4 weeks after the intervention. The study will evaluate changes in participants' competency and confidence in providing perinatal grief care and compare the sustainability of learning outcomes between the two digital education models.

Digital Perinatal Bereavement Support Program for Women After Pregnancy Loss

This study aims to evaluate the effectiveness of a digital perinatal bereavement support program designed for women who have experienced pregnancy loss. Perinatal loss is associated with significant psychological distress, including grief, depression, and anxiety, which may persist over time if not adequately addressed. The intervention consists of a structured digital support program delivered over five weeks, focusing on emotional processing, coping strategies, and psychological resilience. Participants were assessed at baseline, immediately after the intervention, and during follow-up periods at 1 month, 3 months, and 6 months. The primary objective is to determine whether the intervention improves psychological outcomes, including grief and depressive symptoms. The findings are expected to contribute to the development of accessible and scalable mental health support models for women experiencing perinatal loss.

The Effect of Mandala Coloring on Perinatal Grief and Psychological Resilience Levels in Women Experiencing Perinatal Loss

The goal of this clinical trial is to evaluate if mandala colouring helps to decrease grief symptoms and increase resilience in women who experienced perinatal loss. The main questions are: Does mandala coloring decrease perinatal grief symptoms? Does mandala coloring increase resilience? Researchers will compare mandala coloring intervention with standard perinatal loss nursing care to evaluate if mandala coloring works to decrease grief symptoms. Participants will: Answer some questionnaires and scales, and do mandala coloring at least for 20 minutes for 10 days after perinatal loss experience.

The Effect of Nursing Care With Peri-Natal Loss

This study was planned to evaluate the effect of standardised nursing care given to women with perinatal loss using the nursing process on perinatal grief, posttraumatic stress and postpartum depression. H01: There is no difference between pre-test, post-test and follow-up tests in terms of perinatal grief scale mean scores in the intervention group. H02: There is no difference between pre-test, post-test and follow-up tests in terms of IES-R mean scores in the intervention group. H03: There is no difference between pre-test, post-test and follow-up tests in terms of EPDS mean scores in the intervention group. H04: There is no difference between the pre-test post-test and follow-up tests in terms of the mean scores of the Complicated Grief Scale in the intervention group. * At the first encounter with women, the mean scores of PMI, IESR and EPDS will be evaluated. * The mean EPDS score will be evaluated on the 10th postpartum day, 1st, 3rd and 6th month. * The mean I-ESR scale score will be evaluated at postpartum 1st, 3rd and 6th month. * At postpartum 1st and 3rd month, the mean score of PMS will be evaluated. * At the postpartum 6th month, the mean score of the PBI scale will be evaluated.