NCT02418026

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Status
completed

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

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 1, 2017

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

April 7, 2015

Results QC Date

November 15, 2016

Last Update Submit

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 INTERVENTION

women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care

Hypnosis

EXPERIMENTAL

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

Interventions

Conversational hypnotic induction and therapeutic suggestions

Hypnosis

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

PainAnxiety Disorders

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Mrs Sandrine Delavaux
Organization
Groupe Hospitalier de la Rochelle Ré Aunis

Study Officials

  • Sandrine DELAVAUX

    Groupe Hospitalier de la Rochelle Ré Aunis

    PRINCIPAL INVESTIGATOR

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