Virtual Reality-Supported Psychosocial Care for Women After Perinatal Loss

NCT07124897 | Not Yet Recruiting

• 1 other identifier: 30.01.2025-263
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Death

Keywords

Virtual Reality; Perinatal Loss; Psychosocial; Nursing Care; Psychosocial Health

Outcome Measures

Primary Outcomes (3)

• Depression, Anxiety, and Stress Levels

  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.

  Baseline (hospital admission), Day 7 post-discharge, Day 30 post-discharge

• Perinatal Grief Levels

  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.

  Baseline (hospital admission), Day 7 post-discharge, Day 30 post-discharge

• Postpartum Depression Levels

  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.

  Day 7 post-discharge, Day 30 post-discharge

Other Outcomes (1)

• Assessment of Sociodemographic, Obstetric, and Gynecological Characteristics

  Baseline (hospital admission)

Study Arms (2)

VR_PSYCARE: VR-Supported Psychosocial Care + Routine Care

EXPERIMENTAL

Participants receive psychosocial nursing care based on Swanson's Theory of Caring, supported by VR, in addition to routine hospital care. The intervention includes face-to-face and at-home psychosocial care and telephone follow-up on Day 7 and Day 30 after discharge. VR content has two main components: (1) educational videos and multimedia materials addressing physical and reproductive health needs after perinatal loss, and (2) psychosocial content using 360° VR videos with guided breathing exercises, affirmations, and relaxation practices. This group is supported through follow-up calls and the continuation of at-home psychosocial care, including encouragement to practice breathing exercises, keep a daily journal, and receive supportive postpartum information.

Behavioral: VR-Supported Psychosocial Nursing Care Based on Swanson's Theory of Caring

NONVR_PSYCARE: Psychosocial Care + Routine Care

ACTIVE COMPARATOR

Participants receive psychosocial nursing care based on Swanson's Theory of Caring, without VR, in addition to routine hospital care. The intervention includes face-to-face and at-home psychosocial care and telephone follow-up on Day 7 and Day 30 after discharge. This group is supported through follow-up calls and the continuation of at-home psychosocial care, including encouragement to practice breathing exercises, keep a daily journal, and receive supportive postpartum information.

Behavioral: Psychosocial Nursing Care Based on Swanson's Theory of Caring

Interventions

VR-Supported Psychosocial Nursing Care Based on Swanson's Theory of Caring BEHAVIORAL

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 of immersive, calming 360-degree visual environments that are integrated into the care sessions to promote emotional regulation. The intervention continues with structured psychosocial support via telephone on day 7 and day 30 after discharge.

Also known as: VR_PSYCARE, Swanson-Based VR Care

VR_PSYCARE: VR-Supported Psychosocial Care + Routine Care

Psychosocial Nursing Care Based on Swanson's Theory of Caring BEHAVIORAL

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-up support is also provided via telephone calls on day 7 and day 30 after discharge, continuing the psychosocial care process without any technological enhancement.

Also known as: NONVR_PSYCARE, Swanson-Based Psychosocial Care

NONVR_PSYCARE: Psychosocial Care + Routine Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duygu Dişli Çetinçay: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

Location

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Engindeniz, A. N., Küey, L., & Kültür, S. (1996). Edinburgh Doğum Sonrası Depresyon Ölçeği Türkçe Formu Geçerlilik ve Güvenilirlik Çalışması. Bahar Sempozyumları, 1, 51-52.

  BACKGROUND

• Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

  PMID: 3651732 BACKGROUND

• 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.

  BACKGROUND

• Toedter LJ, Lasker JN, Janssen HJ. International comparison of studies using the perinatal grief scale: a decade of research on pregnancy loss. Death Stud. 2001 Apr-May;25(3):205-28. doi: 10.1080/07481180125971.

  PMID: 11785540 BACKGROUND

• Sarıçam, H. (2018). The Psychometric Properties of Turkish Version of Depression Anxiety Stress Scale-21 (DASS-21) in Community and Clinical Samples. Journal of Cognitive-Behavioral Psychotherapy and Research, 7(1), 1.

  BACKGROUND

• Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.

  PMID: 16004657 BACKGROUND

• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

  PMID: 7726811 BACKGROUND

MeSH Terms

Conditions

Perinatal Death

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Duygu Dişli Çetinçay, RN, MSc

  Haliç University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duygu Dişli Çetinçay, RN, MSc

CONTACT

+90536 996 6776; disliduygu@gmail.com

Meltem Kaydırak, PhD, AssocProf

CONTACT

+90 532 202 7786; meltemecdi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, RN, MSc, PhD Student

Model Details: This randomized controlled trial uses a parallel assignment model. Participants who meet the inclusion criteria are randomly assigned to one of two groups. The VR\_PSYCARE group (experimental arm) receives VR-supported psychosocial nursing care based on Swanson's Theory of Caring, in addition to routine hospital care. The NONVR\_PSYCARE group (control arm) receives psychosocial nursing care based on the Swanson's Theory of Caring, without VR, in addition to routine hospital care. The intervention consists of multiple phases: baseline assessment during hospitalization, face-to-face and at-home psychosocial care, and follow-up via telephone on Day 7 and Day 30 after discharge. Psychological outcomes-including depression, anxiety, stress, and grief-are measured using validated scales. Randomization ensures unbiased allocation, and the parallel design enables a direct comparison between the two intervention arms.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 15, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)