Skip to content

Providing Psychological and Emotional Support After Perinatal Loss: A Virtual Reality-Based Intervention

Évaluer l'efficacité d'Une Intervention en réalité Virtuelle Sur le Bien-être Des Femmes Ayant vécu un décès périnatal : un Essai contrôlé randomisé

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04656977
Acronym
DIANE
Enrollment
40
Registered
2020-12-07
Start date
2020-11-16
Completion date
2022-10-31
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grief, Perinatal

Keywords

Perinatal loss, Perinatal grief, Women mental health, Virtual reality, Psychological intervention

Brief summary

The loss of an infant during the perinatal period has been recognized as a complex and potentially traumatic life event and can have a significant impact on women's mental health. However, often times, psychological aftercare is typically not offered, and manualized interventions are rarely used in clinical care practice and have seldom been evaluated. In recent years, a growing number of studies have demonstrated the efficacy of virtual reality (VR) interventions to facilitate the expression and coping with emotions linked to a traumatic event. The objective of the proposed paper is to present the protocol of a randomized control trial aimed to assess a novel VR-based intervention for mothers who experienced a perinatal loss. The investigators hypothesize that the VR-based intervention group will show significantly reduced symptoms related to grief, postnatal depression and general psychopathology after treatment relative to a treatment-as-usual (TAU) group. With the present study the investigators propose to answer to the unquestionable need for interventions addressed to ameliorate the emotional effects in women who experienced perinatal loss, by exploiting also the therapeutic opportunities offered by a new technology as VR.

Interventions

OTHERVR

The proposed intervention will consist in three weekly sessions of 2h focused, respectively, on: (1) gathering information about the loss and psychoeducation about perinatal grief, and introduction to the virtual environment; (2) through the use of the virtual environment, women will be assisted in the elaboration and acceptation of loss; (3) recreate, using the features of the virtual environment (i.e., a series of different virtual landscapes and symbolic elements personalized to each participant as personal pictures, sounds or videos) a new and positive metaphor representing the woman's future life.

OTHERTAU

The TAU condition is a homogenous standard program proposed by the CERIF at UQO based on group counseling offered to women and men who experienced a perinatal loss.

Sponsors

Canadian Research Chair in Family Psychosocial Health
CollaboratorUNKNOWN
Fonds de la Recherche en Santé du Québec
CollaboratorOTHER_GOV
Universite du Quebec en Outaouais
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Mothers who had recently experienced a perinatal death, including: having lost a child during pregnancy because of miscarriage (i.e., embryo or fetus death prior the 28th week of gestation); termination due to medical indications; stillbirth (i.e., fetus death after 28 completed weeks of gestation); or neonatal death (i.e., infant death within the first 7 days of life). * Women who have experienced perinatal death while pregnant within no more than 1 year before the enrollment will be invited to participate to the study.

Exclusion criteria

* Significant vision impairments despite wearing corrective glasses or lenses. * Presence of a severe and disabling diagnosed mental disorder which requires immediate treatment. * Being under psychological treatment.

Design outcomes

Primary

MeasureTime frame
Positive and Negative Affect Scale (change)Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Clinical Global Impression rated by the therapist (change)Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Perinatal Grief Scale (change)Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Inventory of Complicated Grief (change)Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Beck Depression Inventory-II (change)Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Edinburgh Postnatal Depression Scale (change)Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
State and Trait Anxiety Inventory form Y (change)Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1

Secondary

MeasureTime frame
Client Satisfaction QuestionnaireUp to 3 weeks from day 1, up to 6 weeks from day 1

Countries

Canada

Contacts

Primary ContactGiulia Corno, Ph.D.
giulia.corno@uqo.ca819-595-3900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026