Improving Cesarean Section Experience Through Hypnotherapy

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418026
• Other study ID #: 2014/P01/034
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: October 2013

Study information

• Verified date: January 2024
• Source: Groupe Hospitalier de la Rochelle Ré Aunis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Cesarean Section
• Pain

Intervention

Other:
• hypnosis
Conversational hypnotic induction and therapeutic suggestions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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".	Day 2
Secondary	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".	Day 3
Secondary	Score at Numeric Pain Rating Scale	The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)	just after surgery, up to 1 hour
Secondary	Score at Numeric Pain Rating Scale	The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)	day 1
Secondary	Score at Numeric Pain Rating Scale	The numeric pain rating scale range from 0 (no pain) to 10 (worst pain imaginable)	day 3
Secondary	Mean Blood Pressure		preoperative, up to 2 hours
Secondary	Mean Blood Pressure		during surgery (average), up to 2 hours
Secondary	Mean Blood Pressure		for 2 hours in the recovery room at regular intervals (average)
Secondary	Mean Pulse		preoperative, up to 2 hours
Secondary	Mean Pulse		during surgery (average), up to 2 hours
Secondary	Mean Pulse		for 2 hours in the recovery room at regular intervals (average)
Secondary	Non-steroidal Anti-inflammatory Drug Intake		day 3