Adaptive Virtual Reality for Coping With Involuntary Early Pregnancy Loss
Phase: NA
Conditions: Early Pregnancy Loss
Sponsor: Universidade da Madeira

 
 
 
 
 
 
 
 
 
 
 
Official title of the study: “Adaptive Virtual Reality for coping with 
involuntary early pregnancy loss – feasibility study” 
Unique Protocol ID nº 07/2023 
Document Date: February 6, 2023 
 
 
 
 

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Adaptive Virtual Reality for coping with involuntary early pregnancy 
loss – feasibility study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Research team: 
 
University of Madeira: 
Mónica Cameirão, Assistant Professor  
Sergi Bermúdez i Badia, Associate Professor 
Rita Costa, Master's student 
Diana Mendes, PhD student 
Gabriel Agrela, Master's student 
 
SESARAM: 
Patrícia Silva, Hospital Assistant, Gynecology and Obstetrics Service  
Inês Sargaço, Intern of Specific Training, Gynecology and Obstetrics Service  
 

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INDEX 
 
INDEX 
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INTRODUCTION 
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Early involuntary gestational loss 
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Virtual reality 
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AViR Project 
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GOALS 
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METHODOLOGY 
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Sample and recruitment 
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Inclusion and exclusion criteria 
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Study design 
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Data collection procedure 
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Data collection tools 
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Data processing and analysis 
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Dissemination of results 
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ETHICS 
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General considerations 
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Data protection 
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BIBLIOGRAPHY 
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INTRODUCTION 
 
Early involuntary gestational loss 
An involuntary early pregnancy loss, or miscarriage, occurs in about 20% of 
pregnancies (Quenby et al., 2021), catching parents by surprise and often resulting in 
long periods of grief and psychological stress (Brier, 2008;  deMontigny et al., 2017).  In 
the present study, we define early pregnancy loss as a loss that occurs in the first 20 
weeks of gestation.  A gestational loss, even in the earliest stages, can lead to chronic 
grief that goes on for years, not showing the typical decline of grief seen in other 
situations, even after the birth of another child (Markin, 2017).  However, despite the 
high incidence of miscarriages, parents' psychological distress is often devalued 
(Radford & Hugues, 2015;  Bellhouse et al.  2018), leading to an increase in feelings of 
isolation and implying a high risk for the development of psychological disorders 
(Kulathilaka et al. , 2016;  Farren et al. , 2020).  A recent study of 492 women who 
experienced an early pregnancy loss showed that after one month, 29% had symptoms 
of post-traumatic stress, 24% symptoms of moderate/severe anxiety, and 11% 
symptoms of moderate/severe depression; these decreased over time but were still 
clinically relevant nine months after the loss (Farren et al. , 2020).  It should be noted 
that satisfaction with health services regarding loss management is crucial for a faster 
resolution of psychological distress. A study examining the impact of satisfaction with 
health services on the duration of grief symptoms showed that women dissatisfied 
with the treatment they received still had grief symptoms two years after the loss 
(deMontigny et al. , 2017). 
The high incidence of psychological morbidity after a miscarriage highlights the 
importance of psychological support to manage grief after the event. In fact, several 
studies have shown a decrease in symptoms of grief, post-traumatic stress, depression 
and anxiety when women underwent psychological interventions that helped them 
cope with their losses (Kersting et al. , 2013; Johnson & Langford, 2015). 
Unfortunately, only a limited number of women have access to professional 

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psychological support after a miscarriage, since this service is often unavailable or 
unsolicited (Kersting & Wagner, 2012).  The use of Information and Communication 
Technologies (ICT) has great potential to increase access to emotional and 
psychological support. In the literature, only a limited number of studies explored the 
use of ICTs applied to post-gestational loss support, all were via the internet, but the 
results are very encouraging, showing a decrease in symptoms of post-traumatic 
stress, grief, and depression (Ashford, 2016). 
 
Virtual reality 
Virtual Reality (VR) is a technology with a lot of potential that allows the flexible 
creation of personalized treatment environments based on neuroscientific and clinical 
guidelines. VR enables the creation of well-controlled simulations oriented to the 
needs of patients, using feedback and reward mechanisms, and increasing motivation 
by incorporating treatments into game-like tasks. In addition, it allows you to monitor 
and quantify the performance and evolution of patients over time. VR has been widely 
used in mental health interventions directed at different domains, with the most 
affected disorders being anxiety, substance dependence and eating disorders, with 
very positive results (Cieślik et al. , 2020) . In particular, post-traumatic stress disorder 
is the one that has been most often addressed with VR, usually for exposure 
treatments after a traumatic event (Eshuis et al. , 2021) . In this context, VR has the 
advantage of recreating and exposing patients to traumatic situations in a safe space 
where their emotions can be freely expressed. The adaptability of VR is also a key 
feature, as it allows an easy adjustment of interventions through changes in the 
elements of the simulated environment, as well as adapting the scenarios to the users' 
individual preferences. In addition, VR has been shown to be clinically appropriate for 
implementing psychotherapy techniques such as Cognitive Behavioral Therapy (CBT), 
making it a robust tool for providing such services (Lindner et al. , 2019;  I want et al. , 
2019) . 
Concerning the use of VR for interventions in the area of grief, not necessarily 
derived from a gestational loss, there is very little work. As far as we know, only one 

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study addressed the use of VR for patients suffering from complicated grief (grief that 
does not resolve over time) (Quero et al. , 2019) . A CBT protocol was followed using 
the traditional face-to-face or VR method, and the results were compared at the end 
of treatment, and at 6 and 12 months of follow-up. Although both methods led to 
significant improvements over time, the VR group was superior in clinically significant 
long-term change (Quero et al. , 2019) . The VR system used was EMMA's World, a 
system that has already been used in the treatment of post-traumatic stress and 
adjustment disorders (Guillén et al. , 2018) . The purpose of this system is to help 
process emotions associated with stressful events using 3D objects, sounds, music, and 
elements of personal meaning to the user. This system is also currently being used to 
provide psychological support after pregnancy loss, but at this time, only the protocol 
has been published (Corno et al. , 2020) . Currently, there are no published results on 
the use of VR systems explicitly targeted for gestational loss. 
 
AViR Project 
The AViR project is a project funded by FCT - Foundation for Science and 
Technology (EXPL/CCI-INF/0298/2021) that aims to fill this gap in the literature by 
proposing the use of a multi-scenario VR prototype that uses the adaptability of VR 
and traditional psychological support protocols to provide an adaptable intervention 
and personalized specifically oriented to grief after an early gestational loss. This 
prototype encompasses different virtual scenarios to address various aspects of the 
grief management process. All contents are defined with the collaboration of health 
professionals with experience in psychological support after gestational loss. The 
virtual scenarios are implemented in a VR display to increase the level of immersion 
and presence (Butussi & Chitaro, 2018), allowing the participant to be in a safe space 
where their emotions can be shared freely.  
The present research study proposal aims to evaluate the feasibility of the 
proposed approach by testing the prototype system in a controlled pilot study with 20 
women who suffered an early gestational loss in the last six months. We hypothesize 
that using the proposed VR paradigm will result in a significant reduction in symptoms 

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of grief, depression, anxiety, and post-traumatic stress, and that this reduction will be 
significantly superior when compared to the control group.  
The study we propose is very innovative regarding 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 our 
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. 
 
GOALS 
 
This study has two main objectives: 
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 follow-up;   
2) Evaluate the usability, user experience, and acceptance of the proposed 
approach. 

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METHODOLOGY 
 
Sample and recruitment 
The target population of this pilot study are women who have suffered 
involuntary pregnancy loss in the first 20 weeks of gestation. The recruitment of 
participants will be led by Dr. Patrícia Silva, in collaboration with the Obstetrics and 
Gynecology Service of SESARAM. We intend to recruit a sample of 20 participants who 
will later be divided into two groups, an intervention group using VR and a control 
group that will have access to standard monitoring.  
 
Inclusion and exclusion criteria 
Considering the objective and target population of the AViR project, the sample 
will be composed of women who have experienced early gestational loss, meeting the 
following inclusion criteria: 
1. Have experienced an involuntary gestational loss in the first 20 weeks of 
pregnancy, in the last six months; 
2. Be at least 18 years of age. 
As exclusion criteria, we consider the following factors: 
1. Have a diagnosis of mental disorder; 
2. Be performing psychological intervention; 
3. Being pregnant; 
4. Having some visual deficit that may interfere with the normal performance of 
VR tasks. 
 
Study design  
To test the research hypothesis, the proposed study follows an experimental 
design, 
namely, 
a 
randomized 
controlled 
study 
with 
two 
independent 

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conditions/groups (VR and Control). Participants who meet the inclusion criteria will be 
randomly allocated to one of the two groups described. 
 
Data collection procedure 
 The pilot study will encompass a 4-week intervention and two evaluation 
moments: pre-intervention (baseline) and post-intervention, in which both groups, VR 
and Control, will participate. The VR group will have an intervention program lasting 
four weeks, with three weekly sessions of 45-60 minutes, using the developed 
prototype. 
 
 
 
 
 
 
 
 
 
 
 
 
 
The VR prototype consists of VR glasses (Oculus Quest 2) where participants 
will experience different therapeutic modules, the contents of which were developed 
in collaboration with health professionals with experience in psychological support 
after pregnancy loss. The four modules cover: 1) Psychoeducation, to provide 
information about the grieving process, its phases, emotional and behavioral 
manifestations typical of this period; 2) Validation of loss, to recognize the loss and 
allow the performance of farewell and remembrance rituals; 3) Social sharing, to 
create a safe and judgment-free environment, conducive to sharing the experience 
Pre-intervention assessment scales 
RV Group  
Control Group 
Standard follow-up 
12 sessions (45-60min) 
with VR  
Post-intervention assessment scales 
Usability and experience 
scales 

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with others; and 4)  Adaptation to loss, with a narrative that highlights the importance 
of physical well-being, social contact and the surrounding environment as fundamental 
elements for a healthy lifestyle. The intervention sessions with VR will be held by the 
master's student and graduate in Psychology, Dr.  Rita Costa, who will decide which 
modules to apply in each session depending on each participant's response. The 
control group will do the standard follow-up, normally provided by SESARAM to this 
specific population.  After the post-intervention evaluation, the control group will be 
given the possibility to use the VR system for four weeks, as in the case of the VR 
group. 
The pre- and post-intervention evaluation of both groups includes a set of 
instruments that aim to assess symptoms of grief, depressive and anxious, and post-
traumatic stress. The evaluation of usability and user experience will be carried out 
only by the VR group after the intervention. All evaluations will be carried out by Dr. 
Rita Costa. All participants will be duly informed of the objectives and procedures of 
the study, and will sign the participant information document and informed consent.  
The data collection sessions will take place in the spaces designated for this purpose in 
LifeTech Madeira  (https://lifetech.web.uma.pt), according to the protocol signed by 
the University of Madeira and the Regional Secretariat of Health.  
 
Data collection tools 
To infer the possible effects of the intervention, all participants will respond to 
the following instruments validated for the Portuguese population, pre- and post-
intervention: 
o Perinatal mourning: Perinatal Grief Scale (PGS), a version adapted for the 
Portuguese population (Rocha, 2004). 
o Post-Traumatic Stress: Post-traumatic Stress Disorder Checklist (PCL-5) (DSM-5 
(Diagnostic and Statistical Manual of Mental Disorders, 5th edition), Portuguese 
adaptation (Carvalho et al. , 2020) . 

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o Depressive and Anxious Symptomatology: Hospital Anxiety and Depression 
Scale (HADS), version adapted for the Portuguese population (Pais-Ribeiro et al. 
, 2007). 
 
To assess the usability and user experience  regarding the VR prototype, after the 
intervention, the participants allocated to the intervention group will complete 
questionnaires for the corresponding objectives, namely: 
o Usability: System Usability Scale (SUS)  (Brooke, 1996). 
o Presence: Sense of Presence Inventory (ITC), adapted for the Portuguese 
population (Vasconcelos-Raposo et al. , 2019) . 
o User experience: a questionnaire with open questions on different aspects 
related to the experience of using the VR system. 
 
In addition to the instruments mentioned, a participant form with relevant socio-
demographic and clinical information will also be completed. All the instruments 
referred to are attached to this document. 
 Data processing and analysis 
The results of this study will be explicitly presented in tables and graphs. In 
terms of data description, categorical variables will be presented as absolute values or 
percentages, and quantitative variables will be presented through means, medians, 
standard deviations and quartiles. Regarding the statistical analysis tests, the chi-
square test will be used to compare independent categorical variables; the Student's t-
test to compare parametric variables; the Wilcoxon test to compare intra-subject 
nonparametric variables; and the Mann-Whitney test to compare nonparametric inter-
subject variables. Correlations between variables will be performed using Pearson's 
coefficient for parametric variables and Spearman's coefficient for nonparametric 
variables. For all statistical comparisons, a significance level of 5% (p <.05) will be 
established. The data will be analyzed through the computer program SPSS 24.0 (IBM, 
NY, USA). 

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Dissemination of results 
Considering the proposed project and the innovation of the paradigm and the 
interdisciplinary nature of this work, we aim to produce scientific publications in 
conferences and journals in the areas of Gynecology and Obstetrics, Psychology,  
Informatics applied to health, and/or human-computer communication.  We also 
intend to disseminate the results obtained at regional and national level, specifically in 
health institutions. The goal will be to inform end-users and health professionals of the 
benefits that a system such as the one proposed can have on the population that has 
experienced an early pregnancy loss. Dissemination activities will also play an 
important role in raising awareness of this issue in society in general, thus contributing 
to increased psychological support interventions. 
ETHICS 
 
General considerations 
Considering the good research practices by which we guide our scientific work, 
all the conditions inherent in the ethical principles associated with clinical trials with 
people will be considered. Since this project aims to carry out a study that involves 
collecting data on people, processing of personal data and observing patients, the 
application of appropriate legislation and regulations will be ensured before, during 
and after the implementation of the study. The protocol that has been detailed here is 
under the rules and regulations applied in Portugal and Europe. The professionals 
involved in this project have experience in this area of research and have previously 
coordinated and executed clinical trials that involved collaborations between 
universities and hospitals.  
The project complies with European standards, such as: 

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● The Charter of Fundamental Rights of the European Union (in particular Article 
3 - right to respect for physical and mental integrity and Article 8 - right to 
protect personal data). 
● Declaration of Helsinki: 
o Directive 2001/20/EC of the European Parliament and Council of 4 April 
2001 on the harmonization of laws, regulations and administrative 
provisions of the Member States concerning the implementation of good 
clinical practice in conducting clinical trials on medical devices for 
human use.  
o Council Directive 95/46/EC of the European Parliament and Council of 
24 October 1995 for the protection of individuals with regard to the 
processing of personal data and mobility. 
● Treaty on European Union: Article 6. 
● Charter of Fundamental Rights of 7 December 2000. 
● The project complies with Portuguese standards, such as: 
o Article 35 of the Portuguese Constitution – use of information 
technologies; 
o Law 67/98 – The Personal Data Protection Act. 
 
Data protection 
This protocol is in accordance with the following procedures, with regard to the 
processing of personal data: 
● Data cannot be collected without authorization. Before starting the study, all 
participants will be informed verbally and in writing of the study's details, 
including any risk involved. All participants sign an informed consent before 
participating in the study. 

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● DBirth minutes and other personal data that can identify the person will be 
encrypted to protect the privacy of the patient and the data collected.  
● All the information obtained will only be used within the project's scope and 
will not be saved for other purposes. 
● Personal information will not be published or sold to third parties. 
● Strict technical controls will be used to ensure that the information is not 
inadvertently made available to marketing institutions or third parties. 
 
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