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E-health Intervention for Improving Mental Health During Pregnancy Using Virtual Reality

NCT05756205 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-03-06

No results posted yet for this study

Summary

Pregnancy-related anxiety and depression has received considerable attention worldwide. Mental health problems in pregnant women already since early weeks of gestation may have important consequences for the fetus. Current literature recommends the use of interventions based on new technologies for the treatment of mood disorders, already during the prenatal period. Adult pregnant women (weeks 12-14 of gestation) will be recruited and screened from different primary care centres in Catalonia, Spain. Women who pass the initial mental screening will be randomly allocated to the relaxation virtual reality intervention or control group. The intervention aims to improve mental state of pregnant women during pregnancy, work through breathing, mindfulness and muscle relaxation techniques.

Conditions

  • Anxiety Depression
  • Pregnancy Related

Interventions

DEVICE

Immersive Virtual Reality (IVR)

The intervention will consist of an Immersive Virtual Reality (IVR) application with virtual reality goggles Oculus GO, to reduce anxiety during pregnancy. This application lasts 14 minutes by the use of mindfulness techniques based on breathing, mindfulness and passive muscle relaxation. It consists of three modules that can be chosen completely or separately. The aspects that conform this intervention will be: information about, the most common perinatal mental health problems, exercises based on attention to breathing (mindfulness-relaxation), 6 weeks of duration, for 14 minutes a day, knowledge from involved personnel of the number of times the woman has connected and the time she has done the exercise, satisfaction questions to pregnant women after pregnancy, alerts to notify the principal investigator if there is a problem with e-health, and, finally, an email address to contact the principal investigator.

Sponsors & Collaborators

  • University of Barcelona

    collaborator OTHER

  • Hospital Mutua de Terrassa

    lead OTHER

Principal Investigators

  • Marta Jimenez Barragan, RN, RM · Fundació Assistencial Mutua Terrassa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-02-01
Completion
2024-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05756205 on ClinicalTrials.gov