Early Pregnancy LossAViRNCT05880381
Virtual Reality for Coping With Involuntary Early Pregnancy Loss
A study testing Virtual Reality Group in people with Early Pregnancy Loss, run by Universidade da Madeira at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Pregnancy Loss
- What is being tested?
- Virtual Reality Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women that have experienced an involuntary pregnancy loss in the first 20 weeks in the last 6 months;
Who cannot join
- current pregnancy
- having a diagnosis of mental disorder,
- undergoing any psychological intervention,
- vision impairments that could interfere with the execution of the VR tasks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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;
- 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.
Read the 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
- Being tested
- Virtual Reality Group, Control Group
- Keywords
- Virtual Reality, Psychological Intervention, Personalization
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GroupDevice
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 GroupOther
The participants allocated to this group will do the formal standard care provided by the Gynecology- Obstetric service.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Post-Intervention (4-5 weeks after the beginning of the intervention)
Sense of Presence Inventory (ITC)
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.
Measured: Post-Intervention (4-5 weeks after the beginning of the intervention)
User Experience questionnaire
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.
Measured: Post-Intervention (4-5 weeks after the beginning of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 May 2023
- Primary completion30 Jun 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Pregnancy LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of the two groups.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Madeira
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, Serviço de Saúde da Região Autónoma da Madeira- SESARAM
- Responsible party
- Principal investigator, Mónica Cameirão, Universidade da Madeira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880381
- Sponsor's protocol ID
- 07/2023
- Acronym
- AViR
- Status last verified
- May 2026
- First submitted
- 17 Apr 2023
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Virtual Reality for Coping With Involuntary Early Pregnancy Loss
- ClinicalTrials.gov ID
- NCT05880381
- Acronym / sponsor ID
- AViR / 07/2023
- Conditions
- Early Pregnancy Loss
- Keywords
- Virtual Reality, Psychological Intervention, Personalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidade da MadeiraUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, Serviço de Saúde da Região Autónoma da Madeira- SESARAM
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of the two groups.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual Reality GroupPatients 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 | Other | Other: Control GroupThe participants allocated to this group will do the formal standard care provided by the Gynecology- Obstetric service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women that have experienced an involuntary pregnancy loss in the first 20 weeks in the last 6 months;
Key exclusion criteria (4 listed)
- current pregnancy
- having a diagnosis of mental disorder,
- undergoing any psychological intervention,
- vision impairments that could interfere with the execution of the VR tasks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality GroupPatients 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 GroupThe participants allocated to this group will do the formal standard care provided by the Gynecology- Obstetric service. | Other | Control Group |
Primary outcome
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.
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.
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.
3 secondary outcomes
System Usability Scale (SUS)
Time frame: 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)
User Experience questionnaire
Time frame: Post-Intervention (4-5 weeks after the beginning of the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Group in people with Early Pregnancy Loss, run by Universidade da Madeira at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.