Virtual Reality for Coping With Involuntary Early Pregnancy Loss

NCT ID: NCT05880381

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-09-30

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.

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.

Conditions

Early Pregnancy Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality Group

Intervention Type: DEVICE

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.

Control Group

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

Group Type: OTHER

Control Group

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Control Group

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role: collaborator

Serviço de Saúde da Região Autónoma da Madeira- SESARAM

UNKNOWN

Sponsor Role: collaborator

Universidade da Madeira

OTHER

Sponsor Role: lead

Responsible Party

Mónica Cameirão

Assistant Professor and researcher at the University of Madeira

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade da Madeira

Funchal, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Mónica Cameirão, PhD

Role: CONTACT

monica.cameirao@staff.uma.pt

(+351) 291705291 ext. 5291

Facility Contacts

Mónica Cameirão, PhD

Role: primary

monica.cameirao@staff.uma.pt

(+351) 291705291 ext. 5291

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

07/2023

Identifier Type: -

Identifier Source: org_study_id