Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05880381
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-04-17
Brief Title:
Virtual Reality for Coping With Involuntary Early Pregnancy Loss
Sponsor:
Universidade da Madeira
Organization:
Universidade da Madeira
Study Overview
Official Title:
Adaptive Virtual Reality for Coping With Involuntary Early Pregnancy Loss
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
AViR
Brief Summary:
This study aims to provide psychological support to women that experienced an Early Pregnancy Loss when the loss occurs until the 20 weeks of gestation using an innovative Virtual Reality prototype and compare the presence and evolution of psychological distress symptoms pre and post-intervention
The main goals of this study are
1 Evaluate the impact of the proposed VR paradigm in women who suffered a gestational loss in the first 20 weeks of gestation compared to a control group that follows the usual standard care
2 Evaluate the usability user experience and acceptance of the proposed approach
Participants in the VR group will have an intervention program lasting four weeks with 3 weekly sessions of 45-60 minutes using the developed prototype
The main goals of this study are
1 Evaluate the impact of the proposed VR paradigm in women who suffered a gestational loss in the first 20 weeks of gestation compared to a control group that follows the usual standard care
2 Evaluate the usability user experience and acceptance of the proposed approach
Participants in the VR group will have an intervention program lasting four weeks with 3 weekly sessions of 45-60 minutes using the developed prototype
Detailed Description:
Early pregnancy loss occurs in about 20 of all pregnancies and can lead to chronic grief and psychological distress symptomatology Although the high prevalence it is still a very undervalued event and proper follow-up and psychological guidance are often absent
The present research study aims to evaluate the feasibility of a psychological VR-based approach in a controlled pilot study with 20 women who suffered an early gestational loss in the last 6 months Using the developed prototype the experimental VR group will have an intervention program lasting four weeks with 3 weekly sessions of 45-60 minutes
The investigators aimed to verify if the use of the proposed VR paradigm will significantly reduce symptoms of grief depression anxiety and post-traumatic stress and that this reduction will be significantly greater compared to the control group
The study proposed is very innovative in terms of the target population and the use of VR specifically designed to address gestational loss In addition it opens a new avenue of research on a topic that is still silenced and considered taboo in society Thus this interdisciplinary research has an expected scientific technological and social impact namely 1 contributes to a better understanding of the process of psychological recovery after an early gestational loss 2 contributes to the advancement of technologies aimed at psychological support 3 has the potential to accelerate the resolution of grief by bringing emotional and psychological support to women who do not have access to other means of support and 4 contributes to reducing the economic burden on health care by providing tools to improve the well-being of patients
The present research study aims to evaluate the feasibility of a psychological VR-based approach in a controlled pilot study with 20 women who suffered an early gestational loss in the last 6 months Using the developed prototype the experimental VR group will have an intervention program lasting four weeks with 3 weekly sessions of 45-60 minutes
The investigators aimed to verify if the use of the proposed VR paradigm will significantly reduce symptoms of grief depression anxiety and post-traumatic stress and that this reduction will be significantly greater compared to the control group
The study proposed is very innovative in terms of the target population and the use of VR specifically designed to address gestational loss In addition it opens a new avenue of research on a topic that is still silenced and considered taboo in society Thus this interdisciplinary research has an expected scientific technological and social impact namely 1 contributes to a better understanding of the process of psychological recovery after an early gestational loss 2 contributes to the advancement of technologies aimed at psychological support 3 has the potential to accelerate the resolution of grief by bringing emotional and psychological support to women who do not have access to other means of support and 4 contributes to reducing the economic burden on health care by providing tools to improve the well-being of patients
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