Clinical trial NCT05319665: "Connected Caesarean Section": Creating a Virtual Link Between Mothers and Their Infants to Improve Maternal Childbirth Experience: A Pilot Trial
Official title: "connEcted Caesarean Section": Creating a Virtual Link Between MOthers and Their infanTs to ImprOve Maternal Childbirth experieNce: a PILOT Trial (E-motion-pilot)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Childbirth Experience
Keywords: Mother-infant bonding
Birth satisfaction
HMD
Virtual reality
Caesarean section
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: University of Lausanne
First posted: 2022-04-08
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Childbirth Experience Questionnaire 2 (CEQ-2)
timeFrame: 1 week after the birth
Secondary outcomes:
measure: Perceived Pain Item
timeFrame: During the caesarean section
measure: Perceived Stress Item
timeFrame: At the end of the caesarean section
measure: Perceived Pain Item
timeFrame: At the end of the caesarean section
measure: Satisfaction of the intervention
timeFrame: 1 week after the caesarean section
measure: Maternal symptoms of anxiety or depression
timeFrame: 1 week after the caesarean section
measure: Mother-infant bonding
timeFrame: 1 week after the caesarean section
measure: Satisfaction of the birth
timeFrame: 1 week after the caesarean section
measure: Maternal symptoms of anxiety or depression
timeFrame: 1 month after the caesarean section
measure: Maternal symptoms of PTSD
timeFrame: 1 month after the caesarean section
Other outcomes:
measure: Evolution of the haemodynamic parameters during the caesarean section
timeFrame: During the caesarean section
measure: Presence of perioperative shivers during the caesarean section
timeFrame: During the caesarean section
measure: Presence of nausea related to the surgery or the anesthesia during the caesarean section.
timeFrame: During the caesarean section
measure: Use of medication during the caesarean section.
timeFrame: During the caesarean section
Locations:
city: Lausanne
country: Switzerland
facility: Prof. Antje Horsch
Study officials:
References: