Virtual Reality for Coping With Involuntary Early Pregnancy Loss

NCT05880381 | Recruiting

• 1 other identifier: 07/2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 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. 2.Evaluate the usability, user experience, and acceptance of the proposed approach.

Conditions

Early Pregnancy Loss

Keywords

Virtual Reality; Psychological Intervention; Personalization

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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)

  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 Outcomes (3)

• System Usability Scale (SUS)

  Post-Intervention (4-5 weeks after the beginning of the intervention)

• Sense of Presence Inventory (ITC)

  Post-Intervention (4-5 weeks after the beginning of the intervention)

• User Experience questionnaire

  Post-Intervention (4-5 weeks after the beginning of the intervention)

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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

Control Group

OTHER

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

Other: Control Group

Interventions

Virtual Reality Group 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.

Virtual Reality Group

Control Group OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Women that have experienced an involuntary pregnancy loss in the first 20 weeks in the last 6 months;

You may not qualify if:

• current pregnancy
• having a diagnosis of mental disorder,
• undergoing any psychological intervention,
• vision impairments that could interfere with the execution of the VR tasks.

Sponsors & Collaborators

• Universidade da Madeira: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• Serviço de Saúde da Região Autónoma da Madeira- SESARAM: collaborator

Study Sites (1)

Universidade da Madeira

Funchal, 9020-105, Portugal

RECRUITING

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Mónica Cameirão, PhD

CONTACT

(+351) 291705291; monica.cameirao@staff.uma.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and researcher at the University of Madeira

Model Details: Participants will be randomly assigned to one of the two groups.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 30, 2023
• Study Start: May 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

PT (1)