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

Overview

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.

Full Title of Study: “Évaluer l’efficacité d’Une Intervention en réalité Virtuelle Sur le Bien-être Des Femmes Ayant vécu un décès périnatal : un Essai contrôlé randomisé”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2022

Interventions

  • Other: VR
    • 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.
  • Other: TAU
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: VR+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.
  • Active Comparator: TAU+VR
    • Participants will be invited first to participate to the TAU condition and then to the VR-based intervention.

Clinical Trial Outcome Measures

Primary Measures

  • Perinatal Grief Scale (change)
    • Time Frame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
  • Inventory of Complicated Grief (change)
    • Time Frame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
  • Beck Depression Inventory-II (change)
    • Time Frame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
  • Edinburgh Postnatal Depression Scale (change)
    • Time Frame: 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)
    • Time Frame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
  • Positive and Negative Affect Scale (change)
    • Time Frame: 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)
    • Time Frame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1

Secondary Measures

  • Client Satisfaction Questionnaire
    • Time Frame: Up to 3 weeks from day 1, up to 6 weeks from day 1

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universite du Quebec en Outaouais
  • Collaborator
    • Canadian Research Chair in Family Psychosocial Health
  • Provider of Information About this Clinical Study
    • Principal Investigator: Giulia Corno, Postdoctoral fellow – Universite du Quebec en Outaouais
  • Overall Contact(s)
    • Giulia Corno, Ph.D., 819-595-3900, giulia.corno@uqo.ca

References

Corno G, Bouchard S, Banos RM, Rivard MC, Verdon C, de Montigny F. Providing Psychological and Emotional Support After Perinatal Loss: Protocol for a Virtual Reality-Based Intervention. Front Psychol. 2020 Jun 10;11:1262. doi: 10.3389/fpsyg.2020.01262. eCollection 2020.

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