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

Grief Clinical Trial

— DIANE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04656977
• Other study ID #: 2020-867
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: October 2022

Study information

• Verified date: December 2020
• Source: Universite du Quebec en Outaouais
• Contact: Giulia Corno, Ph.D.
• Phone: 819-595-3900
• Email: giulia.corno[@]uqo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Grief
• Perinatal

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Université du Québec en Outaouais	Gatineau	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Universite du Quebec en Outaouais	Canadian Research Chair in Family Psychosocial Health, Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Corno G, Bouchard S, Baños 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perinatal Grief Scale (change)		Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Primary	Inventory of Complicated Grief (change)		Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Primary	Beck Depression Inventory-II (change)		Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Primary	Edinburgh Postnatal Depression Scale (change)		Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Primary	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
Primary	Positive and Negative Affect Scale (change)		Day 1 (pre-assessment), up to 3 weeks from day 1, up to 6 weeks from day 1
Primary	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	Client Satisfaction Questionnaire		Up to 3 weeks from day 1, up to 6 weeks from day 1