Clinical trial NCT02418026: Improving Cesarean Section Experience Through Hypnotherapy
Official title: Improving Cesarean Section Experience Through Hypnotherapy: a Prospective Single Center Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Pain
Anxiety
Lead sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Wellbeing Measured Using a Comfort Scale
timeFrame: just after surgery, up to 1 hour
Secondary outcomes:
measure: Wellbeing Measured Using a Comfort Scale
timeFrame: Day 2
measure: Wellbeing Measured Using a Comfort Scale
timeFrame: Day 3
measure: Score at Numeric Pain Rating Scale
timeFrame: just after surgery, up to 1 hour
measure: Score at Numeric Pain Rating Scale
timeFrame: day 1
measure: Score at Numeric Pain Rating Scale
timeFrame: day 3
measure: Mean Blood Pressure
timeFrame: preoperative, up to 2 hours
measure: Mean Blood Pressure
timeFrame: during surgery (average), up to 2 hours
measure: Mean Blood Pressure
timeFrame: for 2 hours in the recovery room at regular intervals (average)
measure: Mean Pulse
timeFrame: preoperative, up to 2 hours
measure: Mean Pulse
timeFrame: during surgery (average), up to 2 hours
measure: Mean Pulse
timeFrame: for 2 hours in the recovery room at regular intervals (average)
measure: Non-steroidal Anti-inflammatory Drug Intake
timeFrame: day 3
Other outcomes:
Locations:
Study officials:
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
name: Sandrine DELAVAUX
role: PRINCIPAL_INVESTIGATOR
References: