Post Traumatic Stress Disordere-motion-pilotNCT05319665
"Connected Caesarean Section": Creating a Virtual Link Between Mothers and Their Infants to Improve Maternal Childbirth Experience: A Pilot Trial
A study testing Head-mounted display in people with Post Traumatic Stress Disorder and Childbirth Experience, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, Childbirth Experience
- What is being tested?
- Head-mounted display
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Apr 2022to 17 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Has an established intellectual disability or psychotic illness
- Has photosensitive epilepsy
- Caesarean section under general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Being tested
- Head-mounted display
- Keywords
- Mother-infant bonding, Birth satisfaction, HMD, Virtual reality, Caesarean section
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head-mounted displayDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Head-mounted display |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week after the birth
Secondary outcomes (9)
Perceived Pain Item
Evaluation of experienced pain using the Pain Item during the caesarean section.
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.
Measured: During the caesarean section
Perceived Stress Item
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.
Measured: At the end of the caesarean section
Perceived Pain Item
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.
Measured: At the end of the caesarean section
Satisfaction of the intervention
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.
Measured: 1 week after the caesarean section
Maternal symptoms of anxiety or depression
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.
Measured: 1 week after the caesarean section
Mother-infant bonding
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.
Measured: 1 week after the caesarean section
Satisfaction of the birth
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.
Measured: 1 week after the caesarean section
Maternal symptoms of anxiety or depression
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.
Measured: 1 month after the caesarean section
Maternal symptoms of PTSD
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.
Measured: 1 month after the caesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start8 Apr 2022
- Primary completion1 Nov 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne
- Responsible party
- Principal investigator, Antje Horsch, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319665
- Sponsor's protocol ID
- 2022-00215
- Acronym
- e-motion-pilot
- Status last verified
- Jul 2023
- First submitted
- 25 Mar 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37286319
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05319665
- Acronym / sponsor ID
- e-motion-pilot / 2022-00215
- Keywords
- Mother-infant bonding, Birth satisfaction, HMD, Virtual reality, Caesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- University of Lausanne
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will have the standard-of-care treatment. |
| Interventional | Experimental | Device: Head-mounted displayThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Has an established intellectual disability or psychotic illness
- Has photosensitive epilepsy
- Caesarean section under general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head-mounted displayThe 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. | Device | Interventional |
Primary outcome
Childbirth Experience Questionnaire 2 (CEQ-2)
Time frame: 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.
9 secondary outcomes
Perceived Pain Item
Time frame: During the caesarean section
Perceived Stress Item
Time frame: At the end of the caesarean section
Perceived Pain Item
Time frame: At the end of the caesarean section
Satisfaction of the intervention
Time frame: 1 week after the caesarean section
Maternal symptoms of anxiety or depression
Time frame: 1 week after the caesarean section
Mother-infant bonding
Time frame: 1 week after the caesarean section
Satisfaction of the birth
Time frame: 1 week after the caesarean section
Maternal symptoms of anxiety or depression
Time frame: 1 month after the caesarean section
Maternal symptoms of PTSD
Time frame: 1 month after the caesarean section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 37286319Corbaz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head-mounted display in people with Post Traumatic Stress Disorder and Childbirth Experience, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childbirth Experience Questionnaire 2 (CEQ-2) (time frame: 1 week after the birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05319665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.