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Clinical Trials/NCT04656977
NCT04656977
Unknown
Not 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 Outaouais1 site in 1 country40 target enrollmentNovember 16, 2020
ConditionsGriefPerinatal

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Grief
Sponsor
Universite du Quebec en Outaouais
Enrollment
40
Locations
1
Primary Endpoint
Positive and Negative Affect Scale (change)
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 16, 2020
End Date
October 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Sponsor
Universite du Quebec en Outaouais
Responsible Party
Principal Investigator
Principal Investigator

Giulia Corno

Postdoctoral fellow

Universite du Quebec en Outaouais

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.

Outcomes

Primary Outcomes

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

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

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

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

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

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 Outcomes

  • Client Satisfaction Questionnaire(Up to 3 weeks from day 1, up to 6 weeks from day 1)

Study Sites (1)

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