Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04656977
Status:
UNKNOWN
Last Update Posted:
2020-12-07
First Post:
2020-11-10
Brief Title:
Providing Psychological and Emotional Support After Perinatal Loss A Virtual Reality-Based Intervention
Sponsor:
Universite du Quebec en Outaouais
Organization:
Universite du Quebec en Outaouais
Study Overview
Official Title:
Évaluer lefficacité dUne Intervention en réalité Virtuelle Sur le Bien-être Des Femmes Ayant vécu un décès périnatal un Essai contrôlé randomisé
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIANE
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 womens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None