"Connected Caesarean Section": Creating a Virtual Link Between Mothers and Their Infants to Improve Maternal Childbirth Experience: A Pilot Trial
- Conditions
- Post Traumatic Stress DisorderChildbirth Experience
- Interventions
- Device: Head-mounted display
- Registration Number
- NCT05319665
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 71
- 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.
- Has an established intellectual disability or psychotic illness
- Has photosensitive epilepsy
- Caesarean section under general anesthesia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Interventional Head-mounted display 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.
- Primary Outcome Measures
Name Time Method Childbirth Experience Questionnaire 2 (CEQ-2) 1 week after the birth 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.
- Secondary Outcome Measures
Name Time Method Satisfaction of the intervention 1 week after the caesarean section For the interventional group, their satisfaction of the intervention will be assessed.
12 questions will be asked to the participants of the interventional group on their global satisfaction of the intervention, the utility of the intervention, the comfort of the HMD, the quality of the images, sound and camera-HMD connection, advantages and disadvantages of the HMD. 3 questions will be evaluated on a 5-point Likert-scale. 4 questions will require a yes-no answer and 5 questions will be open questions.
This questionnaire is used as a qualitative questionnaire.Mother-infant bonding 1 week after the caesarean section Mother-Infant Bonding Scale (MIBS) This eight points self-reported questionnaire assesses the mother's feelings towards her newborn in the first week after birth. The eights items are statements describing an emotional response and are rated on a four point Likert scale (0=very much, 3=not at all). Higher score denote worse bonding. The minimum value is 0 and the maximum is 24 points.
Satisfaction of the birth 1 week after the caesarean section Birth Satisfaction Scale-Revised (BSS-R) The BSS-R is a 10-item self-reported questionnaire assessing the perceptions of the birth in order to determine women's satisfaction of their birth experience. It consists of one higher-order factor, experience of childbearing, containing three lower-order factors: quality of care provision, women's personal attributes and stress experienced during labor. The items are evaluated on a Likert-type scale that requests participants to rate their level of agreement with each item (1=strongly disagree, 5=strongly agree). Four of the items are reverse-coded. Higher score denotes a worse satisfaction of the birth. The minimum value is 10 and the maximum is 50 points.
Perceived Pain Item At the end of the caesarean section Evaluation of experienced pain using the Pain Item. A visual analogue scale from 0 to 10 will be shown to the participant. She will be asked to evaluate her pain level on that scale. 0 means no pain at all, 10 is the worst pain imaginable.
Perceived Stress Item At the end of the caesarean section Evaluation of experienced the stress using the Stress Item. A visual analogue scale from 0 to 10 will be shown to the participant. She will be asked to evaluate her stess level on that scale. 0 means no stress at all, 10 is the worst stress imaginable.
Maternal symptoms of anxiety or depression 1 month after the caesarean section Hospital Anxiety and Depression Scale (HADS-A and HADS-D) This self-reported questionnaire measures the severity of anxiety and depression symptoms during the week before replying to the questions. There are two subscales; anxiety and depression. Each of them consists of seven items scored on a four point Likert scale (0= never, 3=most of the time). Higher score reflects greater severity. The minimum value is 0 and the maximum is 42 points.
Maternal symptoms of PTSD 1 month after the caesarean section City Birth Trauma Scale (CityBiTS) (CityBiTS). The City Birth Trauma Scale is a 29-item questionnaire measuring birth-related post-traumatic stress disorder (PTSD) according to DSM-5 criteria of (A) stressor criteria, (B) symptoms of re-experiencing, (C) avoidance, (D) negative cognitions and mood, (E) hyperarousal, (F) duration of symptoms, (E) signification distress or impairment and (F) exclusion criteria or other causes. Items are evaluated with yes/no/maybe or by frequency of the symptoms. A higher score indicates a higher level of PTSD symptoms. The minimum value is 0 and the maximum is 78 points.
Trial Locations
- Locations (1)
Prof. Antje Horsch
🇨🇭Lausanne, Switzerland