Improving Cesarean Section Experience Through Hypnotherapy

January 11, 2024 updated by: Groupe Hospitalier de la Rochelle Ré Aunis

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
Experimental: Hypnosis
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
Conversational hypnotic induction and therapeutic suggestions

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sandrine DELAVAUX, Groupe Hospitalier de la Rochelle Ré Aunis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimated)

April 16, 2015

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2014/P01/034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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