search
Back to results

Virtual Reality for Coping With Involuntary Early Pregnancy Loss (AViR)

Primary Purpose

Early Pregnancy Loss

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Virtual Reality Group
Control Group
Sponsored by
Universidade da Madeira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Early Pregnancy Loss focused on measuring Virtual Reality, Psychological Intervention, Personalization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: - Women that have experienced an involuntary pregnancy loss in the first 20 weeks in the last 6 months; Exclusion Criteria: current pregnancy having a diagnosis of mental disorder, undergoing any psychological intervention, vision impairments that could interfere with the execution of the VR tasks.

Sites / Locations

  • Universidade da MadeiraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Virtual Reality Group

Control Group

Arm Description

Patients allocated to the treatment group will undergo an intervention that comprises 3 weekly sessions of 60 minutes for 4 weeks with the VR prototype.

The participants allocated to this group will do the formal standard care provided by the Gynecology- Obstetric service.

Outcomes

Primary Outcome Measures

Perinatal Grief Scale (PGS)
Portuguese adaptation of Perinatal Grief Scale- PGS (Rocha, 2004) assesses changes pre and post-intervention, in three subscales that involve perinatal grief symptomatology like active grief, difficulty coping and despair. This scale comprises 33 items divided into three subscales that assess active grief, difficulty coping, and despair. Minimum score of 33 and a maximum 165- higher scores represent more severe grief symptoms.
Posttraumatic Stress Disorder Checklist (PCL-5)
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) adapted to the Portuguese population, will be used to evaluate post-intervention changes in post-traumatic stress symptoms. This is a 20-item self-report instrument that assesses the 20 DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) symptoms of PTSD rated from 0 to 4. A minimum score of 0 and a maximum of 80- higher scores represent more severe post-traumatic stress symptoms.
Hospital Anxiety and Depression Scale (HADS)
HADS is a 14-question instrument that measures anxiety and depression with seven questions for each; each question is scored between zero (no impairment) and three (severe impairment), with a maximum score of 21 for anxiety or depression.

Secondary Outcome Measures

System Usability Scale (SUS)
For assessing the overall usability of the prototype, the System Usability Scale (SUS) is a widely used scale that provides a global view of subjective assessments of usability. Scoring varies from 0 to 100, and the bigger the value better the usability assessment.
Sense of Presence Inventory (ITC)
To assess the VR user experience, the ITC - Sense of Presence Inventory adapted to the Portuguese population by Raposo-Vasconcelos et al. will be used. This scale has two parts, the first addressing the user's feelings after the experience, and the second related to the characterization of the experience during the simulation. This inventory includes 44 items organized into four factors: Sense of physical space, Engagement, Ecological validity, and Negative effects. The mean score for each factor can vary from 1 to 5.
User Experience questionnaire
A customized questionnaire with open questions where participants can freely elaborate on any issues related to the VR prototype. Only qualitative data will be analysed with this questionnaire.

Full Information

First Posted
April 17, 2023
Last Updated
May 19, 2023
Sponsor
Universidade da Madeira
Collaborators
Fundação para a Ciência e a Tecnologia, Serviço de Saúde da Região Autónoma da Madeira- SESARAM
search

1. Study Identification

Unique Protocol Identification Number
NCT05880381
Brief Title
Virtual Reality for Coping With Involuntary Early Pregnancy Loss
Acronym
AViR
Official Title
Adaptive Virtual Reality for Coping With Involuntary Early Pregnancy Loss
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade da Madeira
Collaborators
Fundação para a Ciência e a Tecnologia, Serviço de Saúde da Região Autónoma da Madeira- SESARAM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Pregnancy Loss
Keywords
Virtual Reality, Psychological Intervention, Personalization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to one of the two groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Group
Arm Type
Experimental
Arm Description
Patients allocated to the treatment group will undergo an intervention that comprises 3 weekly sessions of 60 minutes for 4 weeks with the VR prototype.
Arm Title
Control Group
Arm Type
Other
Arm Description
The participants allocated to this group will do the formal standard care provided by the Gynecology- Obstetric service.
Intervention Type
Device
Intervention Name(s)
Virtual Reality Group
Intervention Description
Patients allocated to the treatment group will undergo an intervention that comprises 3 weekly sessions of 60 minutes for 4 weeks with the VR prototype.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
The participants allocated to this group will do the formal standard care provided by the Gynecology- Obstetric service.
Primary Outcome Measure Information:
Title
Perinatal Grief Scale (PGS)
Description
Portuguese adaptation of Perinatal Grief Scale- PGS (Rocha, 2004) assesses changes pre and post-intervention, in three subscales that involve perinatal grief symptomatology like active grief, difficulty coping and despair. This scale comprises 33 items divided into three subscales that assess active grief, difficulty coping, and despair. Minimum score of 33 and a maximum 165- higher scores represent more severe grief symptoms.
Time Frame
Pre-intervention (1 week before the beginning of the intervention) and Post-intervention (4 to 5 weeks after the beginning of the intervention)
Title
Posttraumatic Stress Disorder Checklist (PCL-5)
Description
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) adapted to the Portuguese population, will be used to evaluate post-intervention changes in post-traumatic stress symptoms. This is a 20-item self-report instrument that assesses the 20 DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) symptoms of PTSD rated from 0 to 4. A minimum score of 0 and a maximum of 80- higher scores represent more severe post-traumatic stress symptoms.
Time Frame
Pre-intervention (1 week before the beginning of the intervention) and Post-intervention (4 to 5 weeks after the beginning of the intervention)
Title
Hospital Anxiety and Depression Scale (HADS)
Description
HADS is a 14-question instrument that measures anxiety and depression with seven questions for each; each question is scored between zero (no impairment) and three (severe impairment), with a maximum score of 21 for anxiety or depression.
Time Frame
Pre-intervention (1 week before the beginning of the intervention) and Post-intervention (4 to 5 weeks after the beginning of the intervention)
Secondary Outcome Measure Information:
Title
System Usability Scale (SUS)
Description
For assessing the overall usability of the prototype, the System Usability Scale (SUS) is a widely used scale that provides a global view of subjective assessments of usability. Scoring varies from 0 to 100, and the bigger the value better the usability assessment.
Time Frame
Post-Intervention (4-5 weeks after the beginning of the intervention)
Title
Sense of Presence Inventory (ITC)
Description
To assess the VR user experience, the ITC - Sense of Presence Inventory adapted to the Portuguese population by Raposo-Vasconcelos et al. will be used. This scale has two parts, the first addressing the user's feelings after the experience, and the second related to the characterization of the experience during the simulation. This inventory includes 44 items organized into four factors: Sense of physical space, Engagement, Ecological validity, and Negative effects. The mean score for each factor can vary from 1 to 5.
Time Frame
Post-Intervention (4-5 weeks after the beginning of the intervention)
Title
User Experience questionnaire
Description
A customized questionnaire with open questions where participants can freely elaborate on any issues related to the VR prototype. Only qualitative data will be analysed with this questionnaire.
Time Frame
Post-Intervention (4-5 weeks after the beginning of the intervention)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Women that have experienced an involuntary pregnancy loss in the first 20 weeks in the last 6 months; Exclusion Criteria: current pregnancy having a diagnosis of mental disorder, undergoing any psychological intervention, vision impairments that could interfere with the execution of the VR tasks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mónica Cameirão, PhD
Phone
(+351) 291705291
Ext
5291
Email
monica.cameirao@staff.uma.pt
Facility Information:
Facility Name
Universidade da Madeira
City
Funchal
ZIP/Postal Code
9020-105
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mónica Cameirão, PhD
Phone
(+351) 291705291
Ext
5291
Email
monica.cameirao@staff.uma.pt
First Name & Middle Initial & Last Name & Degree
Mónica Cameirão, PhD

12. IPD Sharing Statement

Learn more about this trial

Virtual Reality for Coping With Involuntary Early Pregnancy Loss

We'll reach out to this number within 24 hrs