NCT04656977UnknownNot Applicable

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

Universite du Quebec en Outaouais2 sites in 1 country40 target enrollmentStarted: November 16, 2020Last updated: December 7, 2020

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Sponsor
Enrollment: 40
Locations: 2
Primary Endpoint: Positive and Negative Affect Scale (change)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Supportive Care
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: Female
Accepts 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.

Arms & Interventions

TAU+VR

Active Comparator

Participants will be invited first to participate to the TAU condition and then to the VR-based intervention.

Intervention: TAU (Other)

VR+TAU

Active Comparator

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.

Intervention: TAU (Other)