Perinatal DeathNCT07124897
Virtual Reality-Supported Psychosocial Care for Women After Perinatal Loss
A study testing VR-Supported Psychosocial Nursing Care Based on Swanson's Theory of Caring and Psychosocial Nursing Care Based on Swanson's Theory of Caring in people with Perinatal Death, run by Duygu Dişli Çetinçay at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Death
- What is being tested?
- VR-Supported Psychosocial Nursing Care Based on Swanson's Theory of Caring and Psychosocial Nursing Care Based on Swanson's Theory of Caring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul, 34480
Duygu Dişli Çetinçay, RN, MSc, +90 536 996 6776, disliduygu@gmail.com
Bahar Karakoç, RN, MSc, +90 531 781 9101, baharkarakoc22@hotmail.com
About this study
Official title: The Effect of Virtual Reality-Supported Psychosocial Care on Psychosocial Health in Women Experiencing Perinatal Loss
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:
Read more
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.
Read the 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.
- Conditions
- Perinatal Death
- Being tested
- VR-Supported Psychosocial Nursing Care Based on Swanson's Theory of Caring, Psychosocial Nursing Care Based on Swanson's Theory of Caring
- Keywords
- Virtual Reality, Perinatal Loss, Psychosocial, Nursing Care, Psychosocial Health
- Medical subject headings
- Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-Supported Psychosocial Nursing Care Based on Swanson's Theory of CaringBehavioural
Also called VR_PSYCARE, Swanson-Based VR Care
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 CaringBehavioural
Also called NONVR_PSYCARE, Swanson-Based Psychosocial Care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psychosocial Nursing Care Based on Swanson's Theory of Caring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 7 post-discharge, Day 30 post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start20 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Perinatal DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duygu Dişli Çetinçay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Duygu Dişli Çetinçay, Halic University
- Investigators
- Duygu Dişli Çetinçay, RN, MSc, Principal investigator, Haliç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124897
- Sponsor's protocol ID
- 30.01.2025-263
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the absence of participant consent for external data sharing and institutional policies that restrict the release of raw data.
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.
PubMed 31328602Engindeniz, 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.
PubMed 37906193Kersting 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.
PubMed 22754291Kalanlar B. Hospital Practices for Parents Following Perinatal Loss. Omega (Westport). 2020 Nov;82(1):92-104. doi: 10.1177/0030222818803809. Epub 2018 Oct 3.
PubMed 30282521Fenstermacher 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.
PubMed 23458030Mecdi 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.
PubMed 31550199Cox 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.
PubMed 3651732Toedter 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.
PubMed 11785540Sarıçam, 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.
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.
PubMed 16004657Lovibond 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.
PubMed 7726811
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality-Supported Psychosocial Care on Psychosocial Health in Women Experiencing Perinatal Loss
- ClinicalTrials.gov ID
- NCT07124897
- Acronym / sponsor ID
- 30.01.2025-263
- Conditions
- Perinatal Death
- Keywords
- Virtual Reality, Perinatal Loss, Psychosocial, Nursing Care, Psychosocial Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Duygu Dişli ÇetinçayUniversity, hospital or other
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR_PSYCARE: VR-Supported Psychosocial Care + Routine Care | Experimental | Behavioral: VR-Supported Psychosocial Nursing Care Based on Swanson's Theory of CaringParticipants 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. |
| NONVR_PSYCARE: Psychosocial Care + Routine Care | Active comparator | Behavioral: Psychosocial Nursing Care Based on Swanson's Theory of CaringParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-Supported Psychosocial Nursing Care Based on Swanson's Theory of CaringAlso: VR_PSYCARE, Swanson-Based VR CareThis 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. | Behavioural | VR_PSYCARE: VR-Supported Psychosocial Care + Routine Care |
| Psychosocial Nursing Care Based on Swanson's Theory of CaringAlso: NONVR_PSYCARE, Swanson-Based Psychosocial CareThis 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. | Behavioural | NONVR_PSYCARE: Psychosocial Care + Routine Care |
Primary outcome
Depression, Anxiety, and Stress Levels
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Background: PubMed 31328602Demirel 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.
- BackgroundEngindeniz, A. N., Küey, L., & Kültür, S. (1996). Edinburgh Doğum Sonrası Depresyon Ölçeği Türkçe Formu Geçerlilik ve Güvenilirlik Çalışması. Bahar Sempozyumları, 1, 51-52.
- BackgroundKöneş, 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.
- Results publication: PubMed 37906193Chiu 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.
- Results publication: PubMed 22754291Kersting 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.
- Results publication: PubMed 30282521Kalanlar B. Hospital Practices for Parents Following Perinatal Loss. Omega (Westport). 2020 Nov;82(1):92-104. doi: 10.1177/0030222818803809. Epub 2018 Oct 3.
- Results publication: PubMed 23458030Fenstermacher 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.
- Results publication: PubMed 31550199Mecdi 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.
- Results publication: PubMed 3651732Cox 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.
- Results publication: PubMed 11785540Toedter 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.
- Results publicationSarıçam, 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.
- Results publication: PubMed 16004657Henry 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the absence of participant consent for external data sharing and institutional policies that restrict the release of raw data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Duygu Dişli Çetinçay, RN, MSc principal investigator
Haliç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-Supported Psychosocial Nursing Care Based on Swanson's Theory of Caring and Psychosocial Nursing Care Based on Swanson's Theory of Caring in people with Perinatal Death, run by Duygu Dişli Çetinçay at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duygu Dişli Çetinçay, RN, MSc (+90536 996 6776, disliduygu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, Anxiety, and Stress Levels (time frame: Baseline (hospital admission), Day 7 post-discharge, Day 30 post-discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07124897, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.