Improving Cesarean Section Experience Through Hypnotherapy

Study Overview
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Brief Summary
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Cesarean section rates continue to increase worldwide, particularly in middle- and high-income countries. In France, the rate has now stabilized around 20 %. Cesarean section is a particular way of giving birth, sometimes desired, but sometimes feared. If some women do not feel affected by this way of giving birth, it is more difficult for others to live with. In this way, not being able to give birth trough natural way may be disturbing in motherhood. At La Rochelle hospital, more than 230 healthcare providers have been trained according to Erickson's hypnosis methodology. Among them, 40 are part of the anesthesia department and a committee oversees the hypnotherapist activities in pain management. The objective of the present study is to assess the benefit of hypnosis session for improving experience and reducing anxiety in women giving birth through surgery.

Detailed Description
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Nonpharmacological approaches for pain management, either as a primary method or as a complement to pharmacological approaches, are suggested for a better perinatal management. The investigators assessed the use of conversational hypnotic induction and therapeutic suggestions during cesarean section as a complement to pharmacological strategy. Women giving birth through scheduled or unplanned cesarean section and who accepted hypnotherapy session were compared to a control group.

Official Title
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Improving Cesarean Section Experience Through Hypnotherapy: a Prospective Single Center Case-control Study

Conditions
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Anxiety, Pain, Cesarean Section

Intervention / Treatment
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* Other: hypnosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 scheduled or unplanned cesarean section Informed consent Exclusion Criteria: Refusal of the patient to participate in the study Not French speaking Patients under guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care | |
| Experimental: Hypnosis<br>women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care | Other: hypnosis<br>* Conversational hypnotic induction and therapeutic suggestions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wellbeing Measured Using a Comfort Scale | The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to no comfort and 10 corresponds to most comfortable. | just after surgery, up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wellbeing Measured Using a Comfort Scale | The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to no comfort and 10 corresponds to most comfortable. | Day 2 | 
| Wellbeing Measured Using a Comfort Scale | The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to no comfort and 10 corresponds to most comfortable. | Day 3 | 
| Score at Numeric Pain Rating Scale | The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable) | just after surgery, up to 1 hour | 
| Score at Numeric Pain Rating Scale | The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable) | day 1 | 
| Score at Numeric Pain Rating Scale | The numeric pain rating scale range from 0 (no pain) to 10 (worst pain imaginable) | day 3 | 
| Mean Blood Pressure |  | preoperative, up to 2 hours | 
| Mean Blood Pressure |  | during surgery (average), up to 2 hours | 
| Mean Blood Pressure |  | for 2 hours in the recovery room at regular intervals (average) | 
| Mean Pulse |  | preoperative, up to 2 hours | 
| Mean Pulse |  | during surgery (average), up to 2 hours | 
| Mean Pulse |  | for 2 hours in the recovery room at regular intervals (average) | 
| Non-steroidal Anti-inflammatory Drug Intake |  | day 3 |