Improving Cesarean Section Experience Through Hypnotherapy
1 other identifier
interventional
79
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 7, 2015
CompletedFirst Posted
Study publicly available on registry
April 16, 2015
CompletedResults Posted
Study results publicly available
March 1, 2017
CompletedJanuary 17, 2024
January 1, 2024
8 months
April 7, 2015
November 15, 2016
January 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Wellbeing Measured Using a Comfort Scale
Day 2
Wellbeing Measured Using a Comfort Scale
Day 3
Score at Numeric Pain Rating Scale
just after surgery, up to 1 hour
Score at Numeric Pain Rating Scale
day 1
Score at Numeric Pain Rating Scale
day 3
- +7 more secondary outcomes
Study Arms (2)
Control
NO INTERVENTIONwomen who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
Hypnosis
EXPERIMENTALwomen 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
Interventions
Eligibility Criteria
You may qualify if:
- over 18
- scheduled or unplanned cesarean section
- Informed consent
You may not qualify if:
- Refusal of the patient to participate in the study
- Not French speaking
- Patients under guardianship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mrs Sandrine Delavaux
- Organization
- Groupe Hospitalier de la Rochelle Ré Aunis
Study Officials
- PRINCIPAL INVESTIGATOR
Sandrine DELAVAUX
Groupe Hospitalier de la Rochelle Ré Aunis
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2015
First Posted
April 16, 2015
Study Start
February 1, 2013
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
January 17, 2024
Results First Posted
March 1, 2017
Record last verified: 2024-01