Virtual Reality-Supported Psychosocial Care for Women After Perinatal Loss

Not Applicable

Not yet recruiting

• Conditions: Perinatal Death

• Registration Number: NCT07124897
• Lead Sponsor: Duygu Dişli Çetinçay

Brief Summary

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Study Start: 2025-08-20
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression, Anxiety, and Stress Levels	Baseline (hospital admission), Day 7 post-discharge, Day 30 post-discharge	The primary outcome measure will be assessed using the Depression Anxiety Stress Scale-21 (DASS-21), a shortened version of the original 42-item scale (DASS-42). The DASS-21 consists of 21 items grouped into three subscales: depression, anxiety, and stress, with each subscale comprising seven items. Responses are rated on a 4-point Likert scale, and total scores for each subscale are calculated by summing the item scores and multiplying the result by two. Higher scores indicate greater severity of symptoms. The scale will be administered at three time points: baseline (upon hospital admission), Day 7 post-discharge, and Day 30 post-discharge.
Perinatal Grief Levels	Baseline (hospital admission), Day 7 post-discharge, Day 30 post-discharge	Perinatal grief will be assessed using the Perinatal Grief Scale - Short Form (PGS), developed to measure the intensity of grief following perinatal loss. The scale consists of 33 items in its original form; however, the short form includes 32 items rated on a 5-point Likert scale. It comprises three subscales: active grief, difficulty coping, and despair, each containing 11 items. Items are summed to provide a total score ranging from 32 to 160, with higher scores indicating greater levels of grief. Except for items 11 and 32, all items are reverse-scored. The scale can be administered within the first two weeks post-loss or during later stages. The PGS-SF will be administered at baseline (hospital admission), Day 7 post-discharge, and Day.
Postpartum Depression Levels	Day 7 post-discharge, Day 30 post-discharge	Postpartum depression will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), developed to screen for the risk of depression in women during the postnatal period. The EPDS consists of 10 items rated on a 4-point Likert scale, with each item scored from 0 to 3. Total scores range from 0 to 30, with higher scores indicating greater risk of postpartum depression. Items 1, 2, and 4 are scored positively, while the remaining items are reverse-scored. A cutoff score of 13 is used; scores of 13 or higher indicate a potential risk for postpartum depression, while scores of 12 or lower suggest a lower risk. The scale will be administered at Day 7 and Day 30 post-discharge.

Trial Locations

Locations (1)

Başakşehir Çam and Sakura City Hospital; 🇹🇷 Istanbul, Turkey