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

NCT05756205 | Unknown DMC

• 1 other identifier: 02/2018
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Pregnancy; Anxiety; Depression; Virtual Reality; Midwifery

Outcome Measures

Primary Outcomes (2)

• Depression in pregnand women

  Edingburg depression Scale (\>9)

  6 weeks

• Anxiety in pregnand women

  State trait anxiety inventory (\>75%)

  6 weeks

Secondary Outcomes (1)

• Symptom checklist -90-R

  6 weeks

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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)

Routine care

NO INTERVENTION

The control group will receive the usual follow-up pregnancy monitoring, without the e-health intervention.

Interventions

Immersive Virtual Reality (IVR) DEVICE

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.

Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead
• University of Barcelona: collaborator

Study Sites (2)

Fundació Assitencial Mutua Terrassa

Terrassa, Barcelona, 08221, Spain

RECRUITING

Hospital Universitari Mútua Terrassa

Terrassa, Barcelona, 08221, Spain

RECRUITING

Related Publications (2)

• Jimenez-Barragan M, Del Pino Gutierrez A, Sauch Valmana G, Monistrol O, Monge Marcet C, Pallarols Badia M, Garrido I, Carmona Ruiz A, Porta Roda O, Esquinas C, Falguera Puig G. Immersive Virtual Reality eHealth Intervention to Reduce Anxiety and Depression in Pregnant Women: Randomized Controlled Trial. JMIR Hum Factors. 2025 Apr 30;12:e71708. doi: 10.2196/71708.

  PMID: 40306641 DERIVED

• Jimenez-Barragan M, Del Pino Gutierrez A, Garcia JC, Monistrol-Ruano O, Coll-Navarro E, Porta-Roda O, Falguera-Puig G. Study protocol for improving mental health during pregnancy: a randomized controlled low-intensity m-health intervention by midwives at primary care centers. BMC Nurs. 2023 Sep 7;22(1):309. doi: 10.1186/s12912-023-01440-4.

  PMID: 37674184 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Marta Jimenez Barragan, RN, RM

  Fundació Assistencial Mutua Terrassa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Jimenez Barragan, RN, RM

CONTACT

+34937365050; mjimenezb@mutuaterrassa.cat

Pilar Arcusa

CONTACT

+34937365050; parcusa@mutuaterrassa.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a two-arm prospective, randomized, parallel-controlled clinical trial. 150 women will be recruited and screened during their pregnancy

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 6, 2023
• Study Start: December 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: December 30, 2024
• Last Updated: March 6, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)