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

May 19, 2023 updated by: Mónica Cameirão, Universidade da Madeira

Adaptive Virtual Reality for Coping With Involuntary Early Pregnancy Loss

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Portugal
      • Funchal, Portugal, 9020-105
        • Recruiting
        • Universidade da Madeira
        • Contact:
        • Principal Investigator:
          • Mónica Cameirão, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Group
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.
Device: Virtual Reality Group
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.
Other: Control Group
The participants allocated to this group will do the formal standard care provided by the Gynecology- Obstetric service.
Other: Control Group
The participants allocated to this group will do the formal standard care provided by the Gynecology- Obstetric service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perinatal Grief Scale (PGS)
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)
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.
Pre-intervention (1 week before the beginning of the intervention) and Post-intervention (4 to 5 weeks after the beginning of the intervention)
Posttraumatic Stress Disorder Checklist (PCL-5)
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)
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.
Pre-intervention (1 week before the beginning of the intervention) and Post-intervention (4 to 5 weeks after the beginning of the intervention)
Hospital Anxiety and Depression Scale (HADS)
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)
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale (SUS)
Time Frame: Post-Intervention (4-5 weeks after the beginning of the intervention)
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.
Post-Intervention (4-5 weeks after the beginning of the intervention)
Sense of Presence Inventory (ITC)
Time Frame: Post-Intervention (4-5 weeks after the beginning of the intervention)
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.
Post-Intervention (4-5 weeks after the beginning of the intervention)
User Experience questionnaire
Time Frame: Post-Intervention (4-5 weeks after the beginning of the intervention)
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.
Post-Intervention (4-5 weeks after the beginning of the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade da Madeira

Collaborators

Fundação para a Ciência e a Tecnologia
Serviço de Saúde da Região Autónoma da Madeira- SESARAM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

October 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

April 17, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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