CESARCOM study protocol: assessing the impact of therapeutic communication on patients’ anxiety during elective cesarean sections, – a before-and-after interventional study

Abstract

Background

Anxiety is common prior to elective caesarean sections and may negatively affect anesthesia outcomes, postoperative pain management, and maternal mental health. Pharmacological premedication remains controversial, prompting growing interest in non-pharmacological alternatives. Hypnosis-based therapeutic communication, which is founded on empathy and the use of positive verbal and non-verbal language, as well as the conscious avoidance of negative or anxiety-inducing suggestions, has shown promise in other surgical settings. However, its effectiveness in obstetrics has yet to be explored.

Methods

This is a single-centre, prospective, before-and-after study. The study aims to assess whether implementing an on-line (asynchronous) training program on hypnosis-based therapeutic communication for obstetric care teams can reduce maternal anxiety following elective caesarean sections. The study will include two cohorts of 130 patients each: one enrolled before the intervention and one after; both blinded of the intervention phase. 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 (State-Trait Anxiety Inventory score > 45), as well as staff satisfaction, and indicators of the feasibility of implementing the training.

The intervention consists of a brief (<1 hour) training module using podcasts and flashcards, combined with distributing a wordbook that promotes HBTC. Staff participation 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 hypnosis-based therapeutic communication training program 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.

Trial registration

ClinicalTrials.gov, TRN: NCT07137377, Registration date: 22 August 2025.

Background

In recent decades, there has been a significant increase in the rate of caesarean sections (c-sections) worldwide. Anxiety -characterized by feelings of tension, nervousness, and fear-, is highly prevalent before c-sections, with rates ranging from 60 to 83% [1–3]. Apart from the discomfort it causes, pre operative anxiety can impact the quality of anesthesia or postoperative analgesia [4], morbidity [5], postpartum depression [6] and other critical surgical outcomes [7]. Thus, reducing anxiety has become a key objective in obstetric surgery.

To mitigate preoperative anxiety, drug premedication may be considered [8]. However, this approach remains controversial, as its effectiveness is unclear and its systematic use is decreasing [9–11]. This emphasizes the need to develop alternative approaches [8, 12, 13]. In pursuit of this objective, some options have been described [14–16]. One such option is the use of music, which is an easily implementable and effective method of reducing stress and anxiety in expectant mothers [14, 15]. Another option is hypnosis, which has been shown to significantly reduce preoperative anxiety [16]. However, its effectiveness in c-sections has not yet been evaluated, nor has that of hypnosis-based therapeutic communication (HBTC) [17].

HBTC is a specific form of communication that blends active listening and empathy with techniques derived from clinical hypnosis. These include the use of non-verbal communication and positive language strategies, such as positive suggestions and avoiding alarmist or negative phrasing. Patients are particularly sensitive to communication, especially during emotionally charged situations like medical procedures. Such experiences can spontaneously trigger an altered state of consciousness, similar to the trance state induced by formal hypnosis. In this heightened state of suggestibility, negative cues -whether from healthcare professionals or the surrounding environment- can induce a “negative trance” characterized by fear and anxiety. This state can exacerbate discomfort, pain and stress [18–23], and even interfere with physiological processes such as wound healing.

Moreover, patients experiencing a negative trance may be more prone to reactivating past traumatic memories. Conversely, carefully chosen, supportive language can genuinely reassure, calm the patient, improves its comfort and well-being, and fosters better relationships between healthcare providers and patients [17, 23]. These effects are underpinned by active brain processes influenced by psychological mechanisms such as conditioning and expectation [24].

Implementation of an HBTC program closely aligns with the commitment of obstetricians to support patients on their personalised childbirth journeys with the utmost care and compassion, in line with “”participative’, “natural” or “family-centered” c- Sect. [25].

Methods

Aim

The aim of this study is to determine whether HBTC could decrease anxiety levels in patients and the proportion of patients with elevated anxiety levels after elective c-sections.

We will also assess our teams’ satisfaction, and the feasibility of implementing a teaching program on HBTC in an obstetric ward.

Objectives

Primary objective

To assess the impact of a hypnosis-based therapeutic communication wordbook and teaching program on patients’ anxiety levels after elective c-sections, before and after implementation of a HBTC protocol/teaching program.

The program will include the presentation of the fundamental principles of therapeutic communication (active listening, empathy, verbal, non-verbal and paraverbal language) through immersive podcasts and digital flashcards; and the distribution of the “C-section therapeutic communication wordbook” (Appendix 1).

Patients’ will receive STAI questionnaires by email and complete them online. Their responses will be directly transfer to REDCap^®, a data management platform.

We will report difference of means of the post c-section anxiety assessed with the State-State Anxiety Inventory (STAI) score (as a continuous variable) (Appendix 2), each patient’s c-section STAI score will be adjusted on their baseline pre-cesarean score.

Secondary objectives

The secondary objectives are to report differences of proportions of patients with a post- c-section STAI-S score > 45 in the two groups, and to assess the providers satisfaction with the teaching program, as long as the feasibility of implementing such a program in obstetrics.

Team satisfaction -including that of nurses, midwives, physicians, and residents- will be measured using Likert scales.

The feasibility will be assessed by measuring the percentage of team members who completed the online course and who report having read the wordbook, and the percentage of team members who started the course (at least ≥ 5 min connection to the online program) after six months and one year.

Participants

Patients

Inclusion criteria

All pregnant women ≥ 18 years old with elective c-section in the Maternity Unit of the Geneva University Hospitals who will give informed consent as documented by signature.

Exclusion criteria

Patients who do not speak French (interpreter required), because they would then be unable to evaluate communication within the team.

All emergency c-sections.

Medical team

All operating theatre staff members who are willing to participate and active during the teaching phase (obstetricians, anaesthetists, midwives, nurses, anaesthetist nurses, paediatricians), who have completed the training and who have read the wordbook at least once (self-declaration).

Study design and procedure (cf. Fig. 1)

Fig. 1.

CESARCOM, study flow chart and graphical representation of study procedure

Prospective and monocentric study including two groups of patients (one group “before” and one group “after” the implementation of a HBTC program). The study is non-randomised, and the intervention phase is blinded from the patient.

The recruitment process takes place at the Maternity Unit and started in April 2025. Its termination is expected in 2027. Recruitment is carried out by the study coordinators during daily clinical practice. To ensure participants have sufficient time to consider the study, physicians or midwives will inform them during the prenatal consultation at which their c-section is planned (using flyers as a recruitment tool), and they will be invited by the research team to consent during their pre-hospitalisation consultation, a few days before their c-section.

The investigators will explain orally to each participant the nature of the study, its purpose, the procedures involved, the expected duration, the potential risks and benefits, and any discomfort it may cause. Each participant will be informed that the participation in the study is voluntary, that she may withdraw from the study at any time, and that withdrawal of consent will not affect her subsequent medical assistance and treatment. The participant will be informed that her medical records may be examined by authorised individuals other than their general practitioner.

All participants for the study will be provided a participant information sheet describing the study.

The formal consent of a participant, using the approved consent form, will be obtained before the participant is submitted to any study procedure.

First phase: patients’ evaluation before training (n = 130)

The patients included during this phase will represent the pre-intervention group.

On the elective c-section planned date, the patient will receive an email at 6 am, inviting her to complete an on-line a STAI anxiety questionnaire comprising 40 questions (Appendix 2), including both STAI-T (trait) and -S (state) components. At 10 am, or once the first questionnaire is validated, with a limit of 24 h after the c-section (to limit the impact of confounding factors influencing post-partum anxiety), patients will be invited by email through REDCap^® to carry out the STAI-S part again. The research team of care providers will eventually remind the patients to do so.

Second phase – the intervention: team training

The concise (duration of less than one hour) on-line educational program will be made available by a specialised team for the medical and paramedical personnel operating in the c-section theatre.

The program will consist in the presentation of the fundamental principles of HBTC (active listening, empathy, verbal, non-verbal and paraverbal language) through podcasts and digital flashcards, and the distribution of the “C-section hypnosis-based therapeutic communication wordbook” (Appendix 1).

The team will be administered satisfaction questionnaires (see Appendix 3) following the conclusion of the educational program.

Third phase - patients’ evaluation after training (n = 130)

The STAI questionnaires will be administered to patients within the same organization as in the first phase. The only difference in this phase is that the c-section will be performed by staff trained in HBTC (teaching program and HUG wordbook).

The patients included during this phase will constitute the post-intervention group.

Data collection

Regarding patients, the variables collected are detailed in Table 1.

Table 1.

Data collection – characteristics

Patient characteristics	Anesthesia	C-section	Maternal complication	Neonate complication
Age Weight Height ASA classification (I-IV) Gestity/Parity Due date Tobacco consumption History of psychiatric illness (any follow-up in in psychiatry of at least one year during the past 5 years)	Type of anesthesia: general, epidural, spinal or peri-spinal anesthesia Experience of the operator (title, years of experience) Duration of the installation of anesthesia in minutes Anesthesia judged difficult (need for a second pose, and/or second operator or duration ≥20 min) Hypnosis during intervention	Experience of the operator (title, years of experience) Music during the intervention	Death Hemorrhage (≥ 500mL) requiring or not hysterectomy Surgical injury (bladder, bowel, vessel etc.) Insufficient anesthesia Cardiac arrest Maternal assisted ventilation or intubation Duration of intervention ≥ 60 min	Poor neonatal adaptation (Apgar score < 7 at 5 min or arterial cord pH < 7.2) Birth trauma Hospitalisation in neonatal unit

ASA American Society of Anesthesiologists

Concerning the eligible medical team, participants will be asked to fill up demographic data and satisfaction Likert scale (Appendix 3).

Statistical analysis plan and sample size calculation

We will report patient’s and operative characteristics as mean (± standard deviation) for continuous variables and count (percentage) for categorical variables. We will assess baseline and operative differences between the two groups using Brunner-Munzel tests for continuous variables and Chi-squared tests for categorical variables (or exact Fisher tests when required).

Regarding our primary objective, we will test the impact of the intervention on post-c-section STAI-State scores using linear regression including the groups as the independent variable (presence or absence of HBTC) and while adjusting on the pre-cesarean STAI-State scores, history of psychiatric illness, anesthesia characteristics, hypnosis or music during the intervention, any complication during the intervention. Regression model assumptions will be tested using residual plots and checks for multicollinearity.

We estimated the sample size using the G*Power software [26] based on a power analysis for an independent samples t-test. This analysis indicated that 216 patients are required to be able to detect a minimum clinically important difference (MCID) of 4 points on the STAI-State score with a standard deviation of 9 [2], an alpha value of 0.05 and a power of 0.90. To anticipate potential data loss, we plan to include 260 patients.

As a secondary analysis of our primary endpoint, we will also compare the proportion of patients with an elevated anxiety (STAI-S score > 45) after c-section in the two groups (presence or absence of HBTC) using a logistic regression, adjusting on pre-cesarean STAI-State scores, and complication.

Regarding the secondary objectives, we will report medical team’s characteristics and team satisfaction as means (± standard deviation) for continuous variables and counts (percentage) for categorical variables. We will assess differences between the two groups using Brunner-Munzel tests for continuous variables and Chi-squared tests for categorical variables (or exact Fisher tests when required). Moreover, we will report the count (percentage) of team members who completed the online course and count (percentage) of team members who at least started the course (≥ 5 min connection to the online program) after six months and one year.

We will assess statistical significance at a two-sided 0.05 level. Statistical analysis will be performed using R software.

Handling of missing data and drop-outs

Every effort will be made to collect complete data sets. When responding to the questionnaire, participants will not be able to validate their responses if they haven’t answered all items, to limit missing data. If they do not complete their questionnaires 24 h after their delivery, their data won’t be analyzed (“drop outs”).

Collaborators can answer only one question, and we will analyze their data. Missing data will be described as a number and percentage for each variable. As mentioned above, the required number of participants has been increased to compensate for potential losses.

Ethics

This protocol had been accepted by Geneva Ethics Commission under the project ID 2024–02495, the 25th of March 2025.

To note, it has been registered on ClinicalTrials.gov (Identifier: NCT07137377).

Discussion

Relevance

To our knowledge, this would be the first study to evaluate the impact of a teaching program incorporating podcasts and digital flashcards on enhancing HBTC within healthcare teams to reduce anxiety associated with elective caesarean sections. We hope that publishing of our obstetrics-specific HBTC wordbook will help professionals globally in selecting appropriate language to promote patient wellbeing.

Strengths and limitations

A key limitation of a before-and-after study that uses different patient groups, in which the ‘before’ group serves as a control group to evaluate the impact of an intervention, such as provider training, is the potential presence of confounding variables. As the two groups consist of different individuals and are not randomised, differences in outcomes may be influenced by variations in patient characteristics, case complexity, or other contextual factors that are unrelated to the intervention. Furthermore, changes in clinical practices, staffing, or pressures on the healthcare system over time may affect the results. These limitations could reduce the study’s internal validity, making it difficult to attribute any observed improvements or declines solely to the intervention. To minimise this bias, there will only be around six months between the two patient inclusion phases. It is estimated that there will be negligible variation in the practices over this limited timeframe.

Another limitation could be the high rate of loss to follow-up, which is linked to the difficulty of completing an online questionnaire, even a short one, during the immediate postpartum period, especially after a c-section.

One strength of our research protocol is the use of a validated anxiety questionnaire [27], with a validated French translation [28], to optimise our external validity. Also, for our primary endpoint, the post-cesarean STAI score, each patient’s result will be adjusted for their respective pre-cesarean score.

The integration of a dedicated HBTC program on patient anxiety and staff experience in an obstetric surgical setting is intended to improve the patient experience and facilitate communication within the clinical teams.

Abbreviations

HBTC

Hypnosis-based therapeutic communication

HUG

Hôpitaux Universitaires de Genève (Geneva University Hospitals)

ICH-GCP

International Conference on Harmonisation for good clinical practice

MCID

Minimum clinically important difference

STAI

State-State Anxiety Inventory (S= State; T= Trait)

Appendix 1

Extract from the hypnosis-based therapeutic communication wordbook

The table below lists some of the most commonly used examples and is not exhaustive. Its vocation is to “propose” different formulations of certain common phrases.

Towards discomfort and insecurity	Towards comfort and safety
Stem, gun, clamp, electrodes Prick, shoot, cut Fear, pain, cold, noise, deep, sharp	Challenge, opportunity Capacity, courage, resources, will, going beyond, confidence, heat. Well-being, energy, appeasement, relaxation
Don’t worry, everything will be fine.	What gives you this feeling?
Don’t be afraid.	Be reassured. I understand your feeling, it’s normal! Do not suggest it, let the patient express himself. -If the patient evokes fear herself: what are you afraid of? We are the guarantors of your safety
It’s gonna be cold!	You will feel a sensation of freshness.
It won’t be long!	-This will be quick. -This will take the time it takes to be carefully done.
Baby is blocked	We will encourage baby to progress.
C-section
Incision	We start.

Appendix 2

STAI

Self-evaluation questionnaire of the “State -Trait Anxiety Inventory – State” (STAI-S)

INSTRUCTIONS: Some statements that people have used to describe their feelings are given below. Read each statement and then circle the response option to the right to indicate how you feel right now, that is, at this moment. Do not spend too much time on any one statement, but give the answer which seems to describe your present feelings best.

	1 = not at all	2 = a little	3 = somewhat	4 = very much so
1. I feel calm
2. I feel secure
3. I feel tense
4. I feel strained
5. I feel at ease
6. I feel upset
7. I am presently worrying over possible misfortunes
8. I feel satisfied
9. I feel frightened
10. I feel uncomfortable
11. I feel self confident
12. I feel nervous
13. I feel jittery
14. I feel indecisive
15. I am relaxed
16. I feel content
17. I am worried
18. I feel confused
19. I feel steady
20. I feel pleasant

Self-evaluation questionnaire of the “state -Trait anxiety Inventory – Trait” (STAI-T)

INSTRUCTIONS: Some statements that people have used to describe their feelings are given below. Read each statement and then circle the appropriate number to the right of the statement to indicate how you generally feel. There are no right or wrong answers. Do not spend too much time on a single statement, but give the answer that comes closest to how you generally feel.

	1 = almost never	2 = sometimes	3 = often	4 = almost always
1. I feel fine
2. I tire quickly
3. I feel like crying
4. I wish I could be as happy as others seem to be
5. I am losing opportunities because I cannot make decisions fast
6. I feel rested
7. I am calm
8. I feel that difficulties are piling up in such a way that I cannot overcome them
9. I worry too much about things that do not really matter
10. I am happy
11. I am inclined to take things hard
12. I lack self-confidence
13. I feel secure
14. I try to avoid facing a crisis or difficulty
15. I feel blue
16. I am content
17. Some unimportant thoughts run through my mind and bother me
18. I take disappointments so keenly that I cannot get them out of my mind
19. I am a steady person
20. I become tense and upset when I think about my current concerns

Appendix 3

Team satisfaction

	Strongly disagree > Agree strongly
I feel I contribute to the hypnosis-based therapeutic communication mission	1 2 3 4 5
I feel part of a team working toward shared goals	1 2 3 4 5
I enjoyed this on-line teaching program	1 2 3 4 5
I think this type of teaching program is right for me.	1 2 3 4 5
I believe that this type of teaching program is well-suited to meeting hypnosis-based therapeutic communication learning objectives.	1 2 3 4 5
I enjoyed to participate to a c-section in the 3rd study phase (after implementation of the hypnosis-based therapeutic communication wordbook, and the on line training)	1 2 3 4 5
I believe our team should implement this kind of communication in our daily activities	1 2 3 4 5
I believe this project is a real improvement of our standard of care for our patients	1 2 3 4 5
I believe that health care quality is a top priority at HUG maternity ward	1 2 3 4 5
I am proud to work for HUG maternity ward and this is (at least) partly linked to this type of project	1 2 3 4 5

Authors’ contributions

OP, MV : conception, design of the work; have drafted and substantively revised the work. RAKAK, MC, CD : conception, design of the work; have substantively revised the work. SdO, MS: have substantively revised the work. NS, CJ: conception, design of study and especially the statistical analysis plan. S C, VO-G, A-LBH, CY-MLL, AC : have substantively revised the work

Funding

Open access funding provided by University of Geneva. Development and research fund of Geneva University Hospitals. The funder does not have a specific role in the conceptualisation, design, data collection, analysis, decision to publish, or preparation of the manuscript.

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethics approval and consent to partcipate

Accepted by Geneva Ethics Commission under the project ID 2024–02495, the 25th of March 2025. This protocol and the related study are in line with current version of the World Medical Association Declaration of Helsinki, and ICH-GCP (International Conference on Harmonisation for good clinical practice) guidelines. At the time of submission, patient recruitment just started (April 2025). All included patients will sign a consent form if they decide to participate.

Consent for publication

Case Report Forms are coded through REDCap^® and available or request without any possible patient identification.

Competing interests

The authors declare no competing interests.