"Connected Caesarean Section": Creating a Virtual Link Between Mothers and Their Infants to Improve Maternal Childbirth Experience: A Pilot Trial (e-motion-pilot)

Vaud University Hospital Center

Status: Completed

Conditions: Post Traumatic Stress Disorder; Childbirth Experience

Treatments: Device: Head-mounted display

Study type: Interventional

Funder types: Other

Identifiers

NCT05319665

2022-00215

Details and patient eligibility

About

One third of mothers rate their childbirth as traumatic. The prevalence of childbirth-related posttraumatic stress disorder (CB-PTSD) is of 4.7% and the prevalence of childbirth-related posttraumatic stress symptoms (CB-PTSS) of 12.3%. Skin-to-skin contact is a protective factor against CB-PTSD. However, during a caesarean section (CS), skin-to-skin contact is not always feasible and mothers and infants are often separated. In those cases, there is no validated and available solution to substitute this unique protective factor. Based on the results observed in studies using virtual reality (VR) and head-mounted displays (HMDs) and studies on childbirth experience, we hypothesize that enabling the mother to have a visual and auditory contact with her baby could improve her childbirth experience whilst she and her baby are separated. To facilitate this connection, we will use a 2D 360° camera filming the baby linked securely to a head-mounted device (HMD) that the mother can wear during the end of the surgery.

Enrollment: 71 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women aged 18 years old or older
• Planned or unplanned CS at ≥ 34 weeks gestation
• Gave birth to a healthy baby according to pediatric evaluation (APGAR score ≥ 7 at 5 minutes)
• Gave oral consent followed by a written confirmation of consent
• Skin-to-skin contact is not possible or was prematurely interrupted
• Speaks French well enough to participate in study assessments
• Eligibility confirmed by an independent physician for the intervention group
• Partner gave oral consent to be filmed for the intervention group.

Exclusion criteria

• Has an established intellectual disability or psychotic illness
• Has photosensitive epilepsy
• Caesarean section under general anesthesia

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

71 participants in 2 patient groups

Control

No Intervention group

Description:

The control group will have the standard-of-care treatment.

Interventional

Experimental group

Description:

The interventional group will have a head-mounted display whilst still in the operating theatre airing a live video of their newborn filmed by a 2D 360° camera to enable a visual and auditory contact.

Treatment:

Device: Head-mounted display