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

Not Applicable

• Conditions: Perinatal; Grief
• Interventions: Other: VR; Other: TAU

• Registration Number: NCT04656977
• Lead Sponsor: Universite du Quebec en Outaouais

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-10
• Study Start: 2020-11-16
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-03
• Last Update Submitted: 2020-12-03
• Study First Posted: 2020-12-07
• Last Update Posted: 2020-12-07
• Primary Completion: 2022-06
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TAU+VR	VR	Participants will be invited first to participate to the TAU condition and then to the VR-based intervention.
VR+TAU	TAU	Participants will participate first to a VR-based intervention and then to the TAU condition. The TAU condition is a homogenous standard program proposed by the Centre d'études et de recherché en intervention familiale (CERIF) at Université du Québec en Outaouais (UQO) based on group counseling offered to women and men who experienced a perinatal loss.
VR+TAU	VR	Participants will participate first to a VR-based intervention and then to the TAU condition. The TAU condition is a homogenous standard program proposed by the Centre d'études et de recherché en intervention familiale (CERIF) at Université du Québec en Outaouais (UQO) based on group counseling offered to women and men who experienced a perinatal loss.
TAU+VR	TAU	Participants will be invited first to participate to the TAU condition and then to the VR-based intervention.

Primary Outcome Measures

Name	Time	Method
Positive and Negative Affect Scale (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
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
Edinburgh Postnatal Depression Scale (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
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

Secondary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire	Up to 3 weeks from day 1, up to 6 weeks from day 1

Trial Locations

Locations (1)

Université du Québec en Outaouais; 🇨🇦 Gatineau, Quebec, Canada