Clinical trial NCT04656977: Providing Psychological and Emotional Support After Perinatal Loss: A Virtual Reality-Based Intervention
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Grief
Perinatal
Keywords: Perinatal loss
Perinatal grief
Women mental health
Virtual reality
Psychological intervention
Lead sponsor: Universite du Quebec en Outaouais
Sponsor class: OTHER
Collaborators: name: Canadian Research Chair in Family Psychosocial Health
name: Fonds de la Recherche en Santé du Québec
First posted: 2020-12-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Perinatal Grief Scale (change)
timeFrame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
measure: Inventory of Complicated Grief (change)
timeFrame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
measure: Beck Depression Inventory-II (change)
timeFrame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
measure: Edinburgh Postnatal Depression Scale (change)
timeFrame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
measure: State and Trait Anxiety Inventory form Y (change)
timeFrame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
measure: Positive and Negative Affect Scale (change)
timeFrame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
measure: Clinical Global Impression rated by the therapist (change)
timeFrame: Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Secondary outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: Up to 3 weeks from day 1, up to 6 weeks from day 1
Other outcomes:
Locations:
city: Gatineau
country: Canada
facility: Université du Québec en Outaouais
state: Quebec
Study officials:
References:
citation: 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.