Virtual Reality-Supported Psychosocial Care for Women After Perinatal Loss

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDuygu Dişli Çetinçay

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Experiencing neonatal loss

Having a diagnosed psychiatric disorder

Having a visual or hearing impairment

Becoming pregnant through infertility treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: VR_PSYCARE: VR-Supported Psychosocial Care + Routine CareExperimental treatment 1 intervention
Group B: NONVR_PSYCARE: Psychosocial Care + Routine CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (hospital admission), Day 7 post-discharge, Day 30 post-discharge
2

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.

Time frame
Baseline (hospital admission), Day 7 post-discharge, Day 30 post-discharge
3

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.

Time frame
Day 7 post-discharge, Day 30 post-discharge

Secondary outcomes

Other outcomes

1

Assessment of Sociodemographic, Obstetric, and Gynecological Characteristics

A researcher-designed Participant Information Form will be used to collect key background information from participants. The form includes selected items on sociodemographic characteristics (e.g., age, education level), obstetric history (e.g., number of pregnancies, pregnancy planning), and gynecological features (e.g., previous pregnancy loss, complications). It was developed based on relevant literature and will be administered at baseline (hospital admission) to describe the study population.

Time frame
Baseline (hospital admission)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duygu Dişli Çetinçay

Lead sponsor

Halic University

Sponsor institution

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