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

A Randomized Controlled Low-intensity E-health Intervention by Midwives for Improving Mental Health in Pregnant Women

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Anxiety Depression
• Intervention / Treatment: Device: Immersive Virtual Reality (IVR)

Detailed Description

Background: 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. The necessity for more effective health care pathways, including some early interventions that reduce the overall burden of the childbearing situation, appears a key factor for a successful birth and care of the baby. The few studies focalized in interventions, are focused on delivery and post-partum, without taking into account the whole maternity process. Current literature recommends the use of interventions based on new technologies for the treatment of mood disorders, already during the prenatal period. There have been scarce well-designed intervention studies that test technological low-intensity interventions by midwives to address pregnant women's mental health, diminishing anxiety and depression during pregnancy.

Methods/design: 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. Women in the control group will receive standard care offered by the public funded maternity services in Catalonia. The primary outcome measures will include the Edinburg Postnatal Depression (EPDS), State Trait Anxiety Inventory (STAI), Symptom Checklist-90 (SCL-90), and the Cambridge Worry Scale (CWS) instruments. Secondary outcome measures will include the Temperament and Character Inventory-Revised (TCI-R) and the Whooley and Generalized Anxiety Disorder-2 (GAD-2) questions. Routinely, pregnancy monitoring measures will also be evaluated.

Discussion: This study aims to test the efficacy of a low-intensity, midwife-led e-health intervention based on new technologies to work on women's anxiety and depression during pregnancy. The hypothesis is that that low-intensity mental health intervention during pregnancy, using an e-health (virtual reality) as a support tool, will be effective in reducing of anxiety, depressive symptoms, and improving satisfaction with pregnancy follow-up.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta Jimenez Barragan, RN, RM; Phone Number: 41707 +34937365050; Email: mjimenezb@mutuaterrassa.cat
• Study Contact Backup: Name: Pilar Arcusa; Phone Number: +34937365050; Email: parcusa@mutuaterrassa.es

Study Locations

• Spain
  • Barcelona
    • Terrassa, Barcelona, Spain, 08221
      • Recruiting
      • Hospital Universitari Mutua Terrassa
      • Contact: Marta Jimenez-Barragan, MA; Phone Number: +34686698651; Email: mjimenezb@mutuaterrassa.cat
      • Principal Investigator: Marta Jimenez Barragan, MA
      • Sub-Investigator: Olga Monistrol Ruano, PhD
      • Sub-Investigator: Gemma Falguera Puig, PhD
      • Sub-Investigator: Amparo del Pino, PhD
    • Terrassa, Barcelona, Spain, 08221
      • Recruiting
      • Fundació Assitencial Mutua Terrassa
      • Contact: Marta Jimenez-Barragan, MA; Phone Number: +34686698651; Email: mjimenezb@mutuaterrassa.cat
      • Principal Investigator: Marta Jimenez Barragan, MA
      • Sub-Investigator: Olga Monistrol Ruano, PhD
      • Sub-Investigator: Gemma Falguera Puig, PhD
      • Sub-Investigator: Amparo del Pino, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All women who control their pregnancy in the primary care centers of the Sexual and Reproductive Health Care (ASSIR; Atención a la Salut Sexual i Reproductiva) of Mutua Terrassa, Barcelona (Spain)
• The women must present a positive value in the mental health screening performed at the beginning of the pregnancy (weeks 12-14 of gestation).
• Verbal and written literacy understanding of Spanish
• ≥18 years old.

Exclusion Criteria:

• Women with diagnosed psychiatric pathology who are already being followed by the mental health team
• Women victims of gender-based violence who tested positive in the partner violence screen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; 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.	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.
No Intervention: Routine care; The control group will receive the usual follow-up pregnancy monitoring, without the e-health intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression in pregnand women	Edingburg depression Scale (>9)	6 weeks
Anxiety in pregnand women	State trait anxiety inventory (>75%)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom checklist -90-R	Anxiety symptoms (>60%)	6 weeks

Collaborators and Investigators

• Sponsor: Hospital Mutua de Terrassa
• Collaborators: University of Barcelona
• Investigators: Principal Investigator: Marta Jimenez Barragan, RN, RM, Fundació Assistencial Mutua Terrassa

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Estimate): March 6, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Pregnancy; Virtual Reality; Midwifery
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 02/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No