Clinical trial NCT05880381: Virtual Reality for Coping With Involuntary Early Pregnancy Loss
Official title: Adaptive Virtual Reality for Coping With Involuntary Early Pregnancy Loss
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Pregnancy Loss
Keywords: Virtual Reality
Psychological Intervention
Personalization
Lead sponsor: Universidade da Madeira
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: Serviço de Saúde da Região Autónoma da Madeira- SESARAM
First posted: 2023-05-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of the two groups.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Perinatal Grief Scale (PGS)
timeFrame: Pre-intervention (1 week before the beginning of the intervention) and Post-intervention (4 to 5 weeks after the beginning of the intervention)
measure: Posttraumatic Stress Disorder Checklist (PCL-5)
timeFrame: Pre-intervention (1 week before the beginning of the intervention) and Post-intervention (4 to 5 weeks after the beginning of the intervention)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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:
measure: System Usability Scale (SUS)
timeFrame: Post-Intervention (4-5 weeks after the beginning of the intervention)
measure: Sense of Presence Inventory (ITC)
timeFrame: Post-Intervention (4-5 weeks after the beginning of the intervention)
measure: User Experience questionnaire
timeFrame: Post-Intervention (4-5 weeks after the beginning of the intervention)
Other outcomes:
Locations:
city: Funchal
country: Portugal
facility: Universidade da Madeira
Study officials:
References: