Virtual Reality-Supported Psychosocial Care for Women After Perinatal Loss

Official title

The Effect of Virtual Reality-Supported Psychosocial Care on Psychosocial Health in Women Experiencing Perinatal Loss

Overview

The goal of this clinical trial is to evaluate the effect of virtual reality (VR)-supported psychosocial nursing care on the psychosocial health of women aged 18 and older who have experienced perinatal loss (≥20 weeks of gestation). The main questions it aims to answer are: Does VR-supported psychosocial care reduce depression, anxiety, stress, perinatal grief, and postpartum depression compared to psychosocial care without VR support? Researchers will compare two groups: VR-supported psychosocial care Psychosocial care without VR support Participants will complete baseline psychosocial assessments during hospital admission, receive psychosocial nursing care based on Swanson's Theory of Caring - with or without VR support - during hospitalization, take part in follow-up interviews on Day 7 and Day 30 after discharge, and continue the psychosocial care process at home, including practicing breathing exercises, keeping a daily journal, and receiving supportive information about coping after perinatal loss.

Detailed description

Perinatal loss, typically resulting from miscarriage, stillbirth, or neonatal death, is defined as an unwanted pregnancy or infant loss. Considered a traumatic life event, perinatal loss affects the family beyond the loss of the baby, leading to feelings of hopelessness and disappointment about the future. It is a profound source of distress that can result in depression, anxiety, stress, grief, and postpartum depression.

Psychosocial nursing care for women during this period plays a critical role; however, innovative approaches are needed to enhance its effectiveness. Virtual reality (VR) technology provides an immersive environment that can promote relaxation, distract from distressing thoughts, and increase engagement in therapeutic activities. Integrating VR into psychosocial care may help address the complex emotional needs of women following perinatal loss.

This study will evaluate VR-supported psychosocial nursing care, based on Swanson's Theory of Caring, on the psychosocial health outcomes of women aged 18 years and older who have experienced perinatal loss. The intervention includes both educational content addressing physical and reproductive health needs and VR content designed to support psychosocial well-being (360° videos, e.g., forest, seaside), combined with voice-guided breathing exercises, affirmations, and guided relaxation practices.

Interventions

• Behavioral VR-Supported Psychosocial Nursing Care Based on Swanson's Theory of Caring
  This intervention involves psychosocial nursing care based on Swanson's Theory of Caring, supported by VR technology. It is applied to women experiencing perinatal loss, aiming to reduce grief, anxiety, depression, and stress, postpartum depression, and to enhance psychosocial well-being. The care is delivered face-to-face during hospitalization and includes emotional support, active listening, presence, and empathy, aligned with the core concepts of Swanson's theory. The VR component consists o
• Behavioral Psychosocial Nursing Care Based on Swanson's Theory of Caring
  This intervention involves psychosocial nursing care based on Swanson's Theory of Caring, without the use of VR. It is delivered to women who have experienced perinatal loss, aiming to support emotional healing and reduce psychological symptoms such as grief, anxiety, depression, stress, and postpartum depression. The intervention is provided face-to-face during hospitalization and focuses on presence, listening, empathy, and emotional support in alignment with Swanson's caring processes. Follow

Primary outcome measures

• Depression, Anxiety, and Stress Levels [Time frame: Baseline (hospital admission), Day 7 post-discharge, Day 30 post-discharge]
• Perinatal Grief Levels [Time frame: Baseline (hospital admission), Day 7 post-discharge, Day 30 post-discharge]
• Postpartum Depression Levels [Time frame: Day 7 post-discharge, Day 30 post-discharge]

Eligibility criteria

Inclusion criteria

• Willingness to participate in the study
• Being 18 years of age or older
• Having access to a smartphone and the internet
• Having experienced a pregnancy loss at ≥20 weeks of gestation

Exclusion criteria

• Experiencing neonatal loss
• Having a diagnosed psychiatric disorder
• Having a visual or hearing impairment
• Becoming pregnant through infertility treatment
• Inability to speak or understand Turkish

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Başakşehir Çam and Sakura City Hospital — Istanbul

Publications

• Demirel G, Ertekin Pinar S, Bilgic D. Anxiety levels and methods of coping with stress of adolescents undergoing their first gynecological examination. J Psychosom Obstet Gynaecol. 2020 Jun;41(2):131-136. doi: 10.1080/0167482X.2019.1643314. Epub 2019 Jul 22. PMID 31328602
• Engindeniz, A. N., Küey, L., & Kültür, S. (1996). Edinburgh Doğum Sonrası Depresyon Ölçeği Türkçe Formu Geçerlilik ve Güvenilirlik Çalışması. Bahar Sempozyumları, 1, 51-52.
• Köneş, M. Ö., Mecdi Kaydirak, M., Aslan, E., & Yildiz, H. (2017). Perinatal Yas Ölçeği (33 maddeli Kısa Sürüm): Türkçe geçerlilik ve güvenilirlik çalışması. Anadolu Psikiyatri Dergisi, 18(3), 231-236. doi: 10.5455/apd.234509.
• Chiu PL, Li H, Yap KY, Lam KC, Yip PR, Wong CL. Virtual Reality-Based Intervention to Reduce Preoperative Anxiety in Adults Undergoing Elective Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2340588. doi: 10.1001/jamanetworkopen.2023.40588. PMID 37906193
• Kersting A, Wagner B. Complicated grief after perinatal loss. Dialogues Clin Neurosci. 2012 Jun;14(2):187-94. doi: 10.31887/DCNS.2012.14.2/akersting. PMID 22754291
• Kalanlar B. Hospital Practices for Parents Following Perinatal Loss. Omega (Westport). 2020 Nov;82(1):92-104. doi: 10.1177/0030222818803809. Epub 2018 Oct 3. PMID 30282521
• Fenstermacher K, Hupcey JE. Perinatal bereavement: a principle-based concept analysis. J Adv Nurs. 2013 Nov;69(11):2389-400. doi: 10.1111/jan.12119. Epub 2013 Mar 4. PMID 23458030
• Mecdi Kaydirak M, Aslan E. Efficacy of Nursing Support in the Pre- and Postmedical Termination of Pregnancy Phases: A Randomized Study. Omega (Westport). 2021 Nov;84(1):51-68. doi: 10.1177/0030222819877791. Epub 2019 Sep 24. PMID 31550199

Identifiers

NCT: NCT07124897 · 30.01.2025-263

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗