"Connected Caesarean Section": Creating a Virtual Link Between Mothers and Their Infants to Improve Maternal Childbirth Experience: A Pilot Trial

NCT ID: NCT05319665

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2022-11-17

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder; Childbirth Experience

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventional

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.

Group Type: EXPERIMENTAL

Head-mounted display

Intervention Type: DEVICE

The intervention is a visual and auditory contact via a head-mounted display (HMD) worn by the mother airing a live video of her newborn filmed by a 2D 360° camera during and after a caesarean section. The HMD will be worn by the new mother from the moment that her newborn is moved to an adjacent room to receive the initial care until the moment when they can be reunited again. The camera will be placed in the adjacent room where the newborn, the mother's partner and a midwife will be. The camera will film the newborn and transmit the live images and the sound to the HMD worn by the mother. The mother will be able to see and hear what happens in the next room and change her angle of view by moving her head from one side to another.

Interventions

Head-mounted display

The intervention is a visual and auditory contact via a head-mounted display (HMD) worn by the mother airing a live video of her newborn filmed by a 2D 360° camera during and after a caesarean section. The HMD will be worn by the new mother from the moment that her newborn is moved to an adjacent room to receive the initial care until the moment when they can be reunited again. The camera will be placed in the adjacent room where the newborn, the mother's partner and a midwife will be. The camera will film the newborn and transmit the live images and the sound to the HMD worn by the mother. The mother will be able to see and hear what happens in the next room and change her angle of view by moving her head from one side to another.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lausanne

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Antje Horsch

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prof. Antje Horsch

Lausanne, , Switzerland

Countries

Switzerland

References

Corbaz F, Boussac E, Lepigeon K, Gomes Dias D, Marcadent S, Desseauve D, Horsch A. 'connEcted caesarean section': creating a virtual link between MOthers and their infanTs to ImprOve maternal childbirth experieNce - study protocol for a PILOT trial (e-motion-pilot). BMJ Open. 2023 Jun 7;13(6):e065830. doi: 10.1136/bmjopen-2022-065830.

Reference Type: DERIVED

PMID: 37286319 (View on PubMed)

Other Identifiers

2022-00215

Identifier Type: -

Identifier Source: org_study_id