Perinatal Death
Conditions
Keywords
Virtual Reality, Perinatal Loss, Psychosocial, Nursing Care, Psychosocial Health
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.
Interventions
BEHAVIORALVR-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 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.
BEHAVIORALPsychosocial 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-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.
Sponsors
Duygu Dişli Çetinçay
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Sociodemographic, Obstetric, and Gynecological Characteristics | Baseline (hospital admission) | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactDuygu Dişli Çetinçay, RN, MSc
Backup ContactMeltem Kaydırak, PhD, AssocProf
Outcome results
None listed