- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02418026
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
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.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
noiVita SrlsUniversity of Eastern PiedmontCompletedCervical Pain | Pain Management | Lumbar Pain | Muscular | Chronic Pain (Back / Neck)Italy
-
Chinese University of Hong KongNot yet recruitingPain, Acute | Chronic Post Operative Pain | Pain, ChronicHong Kong
-
University of SaskatchewanRoyal University Hospital FoundationCompletedPain | Pain, Acute | Pain, Chronic | Pain, IntractableCanada
-
Kyowa Kirin Co., Ltd.Completed
Clinical Trials on hypnosis
-
Rennes University HospitalCompleted
-
Central Hospital, Nancy, FranceRecruitingCancer | Alzheimer Disease | Myocarditis | ParkinsonFrance
-
University of AarhusAarhus University HospitalCompleted
-
Lone Knudsen, MSc Psych, PhDTerminated
-
Hospital St. Joseph, Marseille, FranceRecruiting
-
Assistance Publique - Hôpitaux de ParisCompletedUsing Virtual Reality to Prevent Pre-operative Anxiety in Ambulatory Surgery Patients (PACAH-UCA HV)Surgery | Hallux ValgusFrance
-
University of WashingtonNational Multiple Sclerosis SocietyCompleted
-
Babes-Bolyai UniversityCompleted
-
HASSAN 1st universityRecruitingPostoperative Pain | Preoperative Anxiety | Hypnosis | Length of Stay | Abdominal SurgeriesMorocco
-
Women's and Children's Hospital, AustraliaCompletedPregnancy | LaborAustralia