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

NCT05319665 | Completed DMC

• 1 other identifier: 2022-00215
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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

Keywords

Mother-infant bonding; Birth satisfaction; HMD; Virtual reality; Caesarean section

Outcome Measures

Primary Outcomes (1)

• Childbirth Experience Questionnaire 2 (CEQ-2)

  Standardised questionnaire of childbirth experience. This self-reported questionnaire measures the maternal childbirth experience with four different subscales: own capacity, perceived safety, professional support and participation. There are 19 items rated on a 4 point Likert scale ranging from 1=totally disagree to 4=totally agree and 3 items rated on a VAS from 1 to 100. Rating of negatively worded statements are reversed. Higher scores indicates a better childbirth experience. The minimum value is 1 and the maximum is 4 points.

  1 week after the birth

Secondary Outcomes (9)

• Perceived Pain Item

  During the caesarean section

• Perceived Stress Item

  At the end of the caesarean section

• Perceived Pain Item

  At the end of the caesarean section

• Satisfaction of the intervention

  1 week after the caesarean section

• Maternal symptoms of anxiety or depression

  1 week after the caesarean section

Other Outcomes (4)

• Evolution of the haemodynamic parameters during the caesarean section

  During the caesarean section

• Presence of perioperative shivers during the caesarean section

  During the caesarean section

• Presence of nausea related to the surgery or the anesthesia during the caesarean section.

  During the caesarean section

Study Arms (2)

Control

NO INTERVENTION

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

Interventional

EXPERIMENTAL

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.

Device: Head-mounted display

Interventions

Head-mounted display 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.

Interventional

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• University of Lausanne: collaborator

Study Sites (1)

Prof. Antje Horsch

Lausanne, 1010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 37286319 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Smart Glasses

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study will consist of two phases. During the first phase, the participants will be the control group and will have the standard-of-care. During the second phase, the participants will be the interventional group and will have a head-mounted display airing a live video of their newborn filmed by a 2D 360° camera to enable a visual and auditory contact.

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 8, 2022
• Study Start: April 8, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 17, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

CH (1)