CommunicationCESARCOMNCT07137377
Assessing the Impact of Therapeutic Communication on Patients' Anxiety During Elective Cesarean Sections
A study testing On line teaching CESARCOM teaching programe (immersive podcasts, digital flashcards) in people with Communication and Anxiety, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Background: Anxiety is highly prevalent before elective caesarean sections and can have a negative impact on anesthetic outcomes, postoperative pain and maternal mental health. The use of pharmacological premedication is controversial, and non-pharmacological alternatives are increasingly being explored. 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
- Communication, Anxiety
- What is being tested?
- On line teaching CESARCOM teaching programe (immersive podcasts, digital flashcards)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Apr 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- -≥18 years
- elective c-section planned in the Maternity Unit of the Geneva University Hospitals
- consent to participate
Who cannot join
- Not-French-speaking patients (interpreter required).
- All emergency c-sections.
- Death during the intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
HUG
Geneva, 1205
Oceane Pécheux, +41 79 55 35 095, oceane.pecheux@hug.ch
Mélissa Vocat, +41 79 55 32 284, melissa.vocat@hug.ch
About this study
Official title: CESARCOM Study Protocol: Assessing the Impact of Therapeutic Communication on Patients' Anxiety During Elective Cesarean Sections, - a Before-and-after Interventional Study
Background:
Anxiety is highly prevalent before elective caesarean sections and can have a negative impact on anesthetic outcomes, postoperative pain and maternal mental health. The use of pharmacological premedication is controversial, and non-pharmacological alternatives are increasingly being explored. Therapeutic communication, based on empathy, positive language and the conscious avoidance of negative or anxiety-inducing suggestions, has shown promise in other surgical settings. However, its effectiveness in obstetrics remains to be explored.
Read more
Methods This is a single-centre, prospective, observational, before-and-after study. The study aims to assess whether implementing an on-line (asynchronous) training programme on therapeutic communication for obstetric care teams can reduce maternal anxiety following elective caesarean sections. The study includes two groups of 130 patients each, one before the intervention and one after. Anxiety levels will be assessed using the French version of the State-Trait Anxiety Inventory score, and the primary outcome will be the difference in scores after caesarean section between the two groups. Secondary outcomes include the proportion of patients with high anxiety levels (STAI-State score >45), as well as staff satisfaction, feeling of relevance, and indicators of the feasibility of implementing the training.
The intervention consists of a short (less than 1 hour) training course using podcasts and flashcards, combined with distributing a lexicon that promotes hypnosis-based therapeutic communication (HBTC). Staff participation, perceived relevance and satisfaction will be assessed using structured questionnaires based on the Likert scale.
Linear and logistic regression analyses will be used to adjust for confounding variables, including baseline anxiety, psychiatric history, and intraoperative complications.
Discussion This is the first study to evaluate the impact of a dedicated HBTC training programme on patient anxiety and staff experience in an obstetric surgical setting. By integrating this approach into routine cesarean section care, our aim is to improve the patient experience and enhance communication practices within clinical teams. The results could inform clinical practices on non-pharmacological strategies in obstetric care.
- Conditions
- Communication, Anxiety
- Being tested
- On line teaching CESARCOM teaching programe (immersive podcasts, digital flashcards)
- Keywords
- hypnosis based therapeutic communication, anxiety, STAI score
- Medical subject headings
- Communication, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On line teaching CESARCOM teaching programe (immersive podcasts, digital flashcards)Behavioural
A short e-learning program (immersive podcasts, digital flashcards) will be carried out for the medical and paramedical staff of the cesarean section operating room, by a specialized team. It will will consist of :
- the presentation of the basic principles of therapeutic communication (listening, empathy, verbal, non-verbal, paraverbal language)
- the distribution of the "HUG communication lexicon/wordbook" .
- educational scenes illustrating the impact of therapeutic communication in the operating room ("good" versus "bad" words).
| Study group | Role | What they receive |
|---|---|---|
| Pre intervention group (before hypnosis-based therapeutic communication reaching programme) | No intervention | Patients' anxiety levels before the implementation of an online teaching programme about hypnosis based therapeutic communication in obstetrics. |
| post intervention group (after hypnosis-based therapeutic communication teaching programme) | Experimental | Patients' anxiety levels after the implementation of an online teaching programme about hypnosis based therapeutic communication in obstetrics. Receives: Behavioral: On line teaching CESARCOM teaching programe (immersive podcasts, digital flashcards) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post elective cesarean anxiety level
To assess the impact of a therapeutic communication wordbook and hypnosis-based therapeutic communication teaching programme on patients' anxiety levels after elective c-section and the proportion of elevated anxiety levels after elective c-sections, before and after implementation of a therapeutic communication protocol/short teaching programme.
Patients' will receive State-State Anxiety Inventory (STAI) scores by email and complete them on line. Their result will be directly transfer to REDCap, data management software.
We will report difference of means of the post c-section anxiety assessed with the STAI score (as a continuous variable), each patient result being adjusted on its pre c-section STAI score (result at baseline).
Minimum STAI score result=20; maximum=80. The higher the score, the greater the level of anxiety.
Measured: Within 24 hours after cesarean.
Secondary outcomes (2)
High anxiety levels proportion
Differences of proportions of patients with a post- c-section State Anxiety Inventory (STAI-S) score > 45 in the two groups, and to assess the providers satisfaction with the teaching programme, as long as the feasibility of implementing such a programme in obstetrics.
Measured: Within the 24 hours after cesareans.
Providers satisfaction
The satisfaction of the team (comprising nurses, midwives, doctors, and residents) will be measured using Likert scales (minimum result=10; maximum=50; the higher is the score, the greater the level of satisfaction)
Measured: At 6 and 12 months after the programme
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start14 Apr 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Patients' anxiety before and after a teaching programme of the providers.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Océane Pécheux, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137377
- Sponsor's protocol ID
- ID 2024-02495
- Other IDs
- PRD 05-2024-II
- Acronym
- CESARCOM
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gaudry E, Vagg P, Spielberger CD. Validation of the State-Trait Distinction in Anxiety Research. Multivariate Behav Res. 1975 Jul 1;10(3):331-41. doi: 10.1207/s15327906mbr1003_6.
PubMed 26829634Lang EV, Hatsiopoulou O, Koch T, Berbaum K, Lutgendorf S, Kettenmann E, Logan H, Kaptchuk TJ. Can words hurt? Patient-provider interactions during invasive procedures. Pain. 2005 Mar;114(1-2):303-9. doi: 10.1016/j.pain.2004.12.028. Epub 2005 Jan 26.
PubMed 15733657Caddick J, Jawad S, Southern S, Majumder S. The power of words: sources of anxiety in patients undergoing local anaesthetic plastic surgery. Ann R Coll Surg Engl. 2012 Mar;94(2):94-8. doi: 10.1308/003588412X13171221501267.
PubMed 22391371Varga K. Suggestive techniques connected to medical interventions. Interv Med Appl Sci. 2013 Sep;5(3):95-100. doi: 10.1556/IMAS.5.2013.3.1. Epub 2013 Sep 16.
PubMed 24265898Boselli E, Demaille N, Fuchs G, Manseur A. [Assessment of the therapeutic communication in order to improve the welcoming of patients in the operating room: impact study]. Can J Anaesth. 2018 Oct;65(10):1138-1146. doi: 10.1007/s12630-018-1167-2. Epub 2018 Jun 11. French.
PubMed 29949092Wilson CJ, Mitchelson AJ, Tzeng TH, El-Othmani MM, Saleh J, Vasdev S, LaMontagne HJ, Saleh KJ. Caring for the surgically anxious patient: a review of the interventions and a guide to optimizing surgical outcomes. Am J Surg. 2016 Jul;212(1):151-9. doi: 10.1016/j.amjsurg.2015.03.023. Epub 2015 Jun 2.
PubMed 26138522Hishikawa K, Kusaka T, Fukuda T, Kohata Y, Inoue H. Anxiety or Nervousness Disturbs the Progress of Birth Based on Human Behavioral Evolutionary Biology. J Perinat Educ. 2019 Oct 1;28(4):218-223. doi: 10.1891/1058-1243.28.4.218.
PubMed 31728113Kassahun WT, Mehdorn M, Wagner TC, Babel J, Danker H, Gockel I. The effect of preoperative patient-reported anxiety on morbidity and mortality outcomes in patients undergoing major general surgery. Sci Rep. 2022 Apr 15;12(1):6312. doi: 10.1038/s41598-022-10302-z.
PubMed 35428818Schaal NK, Fehm T, Wolf OT, Gielen P, Hagenbeck C, Heil M, Fleisch M, Hepp P. Comparing the course of anxiety in women receiving their first or repeated caesarean section: A prospective cohort study. Women Birth. 2020 May;33(3):280-285. doi: 10.1016/j.wombi.2019.05.011. Epub 2019 Jun 6.
PubMed 31176587Pecheux O, Vocat M, Coen M, de Oliveira S, Bouscail Hardy AL, Jaksic C, Silvestrini N, Campelo S, Othenin-Girard V, Montandon-La-Longe CY, Chilin A, Suppan M, Al Khoury Al Kallab R, Daelemans C. CESARCOM study protocol: assessing the impact of therapeutic communication on patients' anxiety during elective cesarean sections, - a before-and-after interventional study. BMC Pregnancy Childbirth. 2025 Oct 14;25(1):1082. doi: 10.1186/s12884-025-08193-9.
PubMed 41088028
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CESARCOM Study Protocol: Assessing the Impact of Therapeutic Communication on Patients' Anxiety During Elective Cesarean Sections, - a Before-and-after Interventional Study
- ClinicalTrials.gov ID
- NCT07137377
- Acronym / sponsor ID
- CESARCOM / ID 2024-02495
- Conditions
- Communication, Anxiety
- Keywords
- hypnosis based therapeutic communication, anxiety, STAI score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 22 Aug 2025 (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.
Background:
Anxiety is highly prevalent before elective caesarean sections and can have a negative impact on anesthetic outcomes, postoperative pain and maternal mental health. The use of pharmacological premedication is controversial, and non-pharmacological alternatives are increasingly being explored. Therapeutic communication, based on empathy, positive language and the conscious avoidance of negative or anxiety-inducing suggestions, has shown promise in other surgical settings. However, its effectiveness in obstetrics remains to be explored.
Methods This is a single-centre, prospective, observational, before-and-after study. The study aims to assess whether implementing an on-line (asynchronous) training programme on therapeutic communication for obstetric care teams can reduce maternal anxiety following elective caesarean sections. The study includes two groups of 130 patients each, one before the intervention and one after. Anxiety levels will be assessed using the French version of the State-Trait Anxiety Inventory score, and the primary outcome will be the difference in scores after caesarean section between the two groups. Secondary outcomes include the proportion of patients with high anxiety levels (STAI-State score >45), as well as staff satisfaction, feeling of relevance, and indicators of the feasibility of implementing the training.
The intervention consists of a short (less than 1 hour) training course using podcasts and flashcards, combined with distributing a lexicon that promotes hypnosis-based therapeutic communication (HBTC). Staff participation, perceived relevance and satisfaction will be assessed using structured questionnaires based on the Likert scale.
Linear and logistic regression analyses will be used to adjust for confounding variables, including baseline anxiety, psychiatric history, and intraoperative complications.
Discussion This is the first study to evaluate the impact of a dedicated HBTC training programme on patient anxiety and staff experience in an obstetric surgical setting. By integrating this approach into routine cesarean section care, our aim is to improve the patient experience and enhance communication practices within clinical teams. The results could inform clinical practices on non-pharmacological strategies in obstetric care.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients' anxiety before and after a teaching programme of the providers.
| Arm | Type | Receives |
|---|---|---|
| Pre intervention group (before hypnosis-based therapeutic communication reaching programme) | No intervention | –Patients' anxiety levels before the implementation of an online teaching programme about hypnosis based therapeutic communication in obstetrics. |
| post intervention group (after hypnosis-based therapeutic communication teaching programme) | Experimental | Behavioral: On line teaching CESARCOM teaching programe (immersive podcasts, digital flashcards)Patients' anxiety levels after the implementation of an online teaching programme about hypnosis based therapeutic communication in obstetrics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- -≥18 years
- elective c-section planned in the Maternity Unit of the Geneva University Hospitals
- consent to participate
Key exclusion criteria (3 listed)
- Not-French-speaking patients (interpreter required).
- All emergency c-sections.
- Death during the intervention.
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 |
|---|---|---|
| On line teaching CESARCOM teaching programe (immersive podcasts, digital flashcards)A short e-learning program (immersive podcasts, digital flashcards) will be carried out for the medical and paramedical staff of the cesarean section operating room, by a specialized team. It will will consist of : * the presentation of the basic principles of therapeutic communication (listening, empathy, verbal, non-verbal, paraverbal language) * the distribution of the "HUG communication lexicon/wordbook" . * educational scenes illustrating the impact of therapeutic communication in the operating room ("good" versus "bad" words). | Behavioural | post intervention group (after hypnosis-based therapeutic communication teaching programme) |
Primary outcome
Post elective cesarean anxiety level
Time frame: Within 24 hours after cesarean.
To assess the impact of a therapeutic communication wordbook and hypnosis-based therapeutic communication teaching programme on patients' anxiety levels after elective c-section and the proportion of elevated anxiety levels after elective c-sections, before and after implementation of a therapeutic communication protocol/short teaching programme. Patients' will receive State-State Anxiety Inventory (STAI) scores by email and complete them on line. Their result will be directly transfer to REDCap, data management software. We will report difference of means of the post c-section anxiety assessed with the STAI score (as a continuous variable), each patient result being adjusted on its pre c-section STAI score (result at baseline). Minimum STAI score result=20; maximum=80. The higher the score, the greater the level of anxiety.
2 secondary outcomes
High anxiety levels proportion
Time frame: Within the 24 hours after cesareans.
Providers satisfaction
Time frame: At 6 and 12 months after the programme
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Results publication: PubMed 26829634Gaudry E, Vagg P, Spielberger CD. Validation of the State-Trait Distinction in Anxiety Research. Multivariate Behav Res. 1975 Jul 1;10(3):331-41. doi: 10.1207/s15327906mbr1003_6.
- Results publication: PubMed 15733657Lang EV, Hatsiopoulou O, Koch T, Berbaum K, Lutgendorf S, Kettenmann E, Logan H, Kaptchuk TJ. Can words hurt? Patient-provider interactions during invasive procedures. Pain. 2005 Mar;114(1-2):303-9. doi: 10.1016/j.pain.2004.12.028. Epub 2005 Jan 26.
- Results publication: PubMed 22391371Caddick J, Jawad S, Southern S, Majumder S. The power of words: sources of anxiety in patients undergoing local anaesthetic plastic surgery. Ann R Coll Surg Engl. 2012 Mar;94(2):94-8. doi: 10.1308/003588412X13171221501267.
- Results publication: PubMed 24265898Varga K. Suggestive techniques connected to medical interventions. Interv Med Appl Sci. 2013 Sep;5(3):95-100. doi: 10.1556/IMAS.5.2013.3.1. Epub 2013 Sep 16.
- Results publication: PubMed 29949092Boselli E, Demaille N, Fuchs G, Manseur A. [Assessment of the therapeutic communication in order to improve the welcoming of patients in the operating room: impact study]. Can J Anaesth. 2018 Oct;65(10):1138-1146. doi: 10.1007/s12630-018-1167-2. Epub 2018 Jun 11. French.
- Results publication: PubMed 26138522Wilson CJ, Mitchelson AJ, Tzeng TH, El-Othmani MM, Saleh J, Vasdev S, LaMontagne HJ, Saleh KJ. Caring for the surgically anxious patient: a review of the interventions and a guide to optimizing surgical outcomes. Am J Surg. 2016 Jul;212(1):151-9. doi: 10.1016/j.amjsurg.2015.03.023. Epub 2015 Jun 2.
- Results publication: PubMed 31728113Hishikawa K, Kusaka T, Fukuda T, Kohata Y, Inoue H. Anxiety or Nervousness Disturbs the Progress of Birth Based on Human Behavioral Evolutionary Biology. J Perinat Educ. 2019 Oct 1;28(4):218-223. doi: 10.1891/1058-1243.28.4.218.
- Results publication: PubMed 35428818Kassahun WT, Mehdorn M, Wagner TC, Babel J, Danker H, Gockel I. The effect of preoperative patient-reported anxiety on morbidity and mortality outcomes in patients undergoing major general surgery. Sci Rep. 2022 Apr 15;12(1):6312. doi: 10.1038/s41598-022-10302-z.
- Results publication: PubMed 31176587Schaal NK, Fehm T, Wolf OT, Gielen P, Hagenbeck C, Heil M, Fleisch M, Hepp P. Comparing the course of anxiety in women receiving their first or repeated caesarean section: A prospective cohort study. Women Birth. 2020 May;33(3):280-285. doi: 10.1016/j.wombi.2019.05.011. Epub 2019 Jun 6.
- Derived from this study: PubMed 41088028Pecheux O, Vocat M, Coen M, de Oliveira S, Bouscail Hardy AL, Jaksic C, Silvestrini N, Campelo S, Othenin-Girard V, Montandon-La-Longe CY, Chilin A, Suppan M, Al Khoury Al Kallab R, Daelemans C. CESARCOM study protocol: assessing the impact of therapeutic communication on patients' anxiety during elective cesarean sections, - a before-and-after interventional study. BMC Pregnancy Childbirth. 2025 Oct 14;25(1):1082. doi: 10.1186/s12884-025-08193-9.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On line teaching CESARCOM teaching programe (immersive podcasts, digital flashcards) in people with Communication and Anxiety, run by University Hospital, Geneva 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 3 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Océane Pécheux (+41795535095, oceane.pecheux@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post elective cesarean anxiety level (time frame: Within 24 hours after cesarean.). 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 NCT07137377, which also lists 10 linked publications.
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 22 Aug 2025.