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Improving Cesarean Section Experience Through Hypnotherapy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02418026
Enrollment
79
Registered
2015-04-16
Start date
2013-02-28
Completion date
2013-10-31
Last updated
2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Cesarean Section, Pain

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.

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.

Interventions

OTHERhypnosis

Conversational hypnotic induction and therapeutic suggestions

Sponsors

Groupe Hospitalier de la Rochelle Ré Aunis
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Wellbeing Measured Using a Comfort Scalejust after surgery, up to 1 hourThe comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to no comfort and 10 corresponds to most comfortable.

Secondary

MeasureTime frameDescription
Wellbeing Measured Using a Comfort ScaleDay 2The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to no comfort and 10 corresponds to most comfortable.
Score at Numeric Pain Rating Scalejust after surgery, up to 1 hourThe numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)
Mean Blood Pressurepreoperative, up to 2 hours
Mean Pulsepreoperative, up to 2 hours
Non-steroidal Anti-inflammatory Drug Intakeday 3

Participant flow

Participants by arm

ArmCount
Control
women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
44
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 hypnosis: Conversational hypnotic induction and therapeutic suggestions
35
Total79

Baseline characteristics

CharacteristicControlHypnosisTotal
Age, Continuous30.6 years
STANDARD_DEVIATION 5.7
31.2 years
STANDARD_DEVIATION 5.3
30.8 years
STANDARD_DEVIATION 5.5
Region of Enrollment
France
44 participants35 participants79 participants
Sex: Female, Male
Female
44 Participants35 Participants79 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 440 / 35
serious
Total, serious adverse events
0 / 440 / 35

Outcome results

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.

Time frame: just after surgery, up to 1 hour

ArmMeasureValue (MEAN)Dispersion
ControlWellbeing Measured Using a Comfort Scale6.7 units on a scaleStandard Deviation 1.7
HypnosisWellbeing Measured Using a Comfort Scale8.0 units on a scaleStandard Deviation 1.4
Secondary

Mean Blood Pressure

Time frame: preoperative, up to 2 hours

ArmMeasureValue (MEAN)Dispersion
ControlMean Blood Pressure96 mm HgStandard Deviation 11
HypnosisMean Blood Pressure101 mm HgStandard Deviation 14
Secondary

Mean Blood Pressure

Time frame: during surgery (average), up to 2 hours

ArmMeasureValue (MEAN)Dispersion
ControlMean Blood Pressure85 mm HgStandard Deviation 10
HypnosisMean Blood Pressure84 mm HgStandard Deviation 10
Secondary

Mean Blood Pressure

Time frame: for 2 hours in the recovery room at regular intervals (average)

ArmMeasureValue (MEAN)Dispersion
ControlMean Blood Pressure87 mm HgStandard Deviation 10
HypnosisMean Blood Pressure88 mm HgStandard Deviation 10
Secondary

Mean Pulse

Time frame: preoperative, up to 2 hours

ArmMeasureValue (MEAN)Dispersion
ControlMean Pulse95 bpmStandard Deviation 17
HypnosisMean Pulse94 bpmStandard Deviation 17
Secondary

Mean Pulse

Time frame: during surgery (average), up to 2 hours

ArmMeasureValue (MEAN)Dispersion
ControlMean Pulse90 bpmStandard Deviation 13
HypnosisMean Pulse90 bpmStandard Deviation 15
Secondary

Mean Pulse

Time frame: for 2 hours in the recovery room at regular intervals (average)

ArmMeasureValue (MEAN)Dispersion
ControlMean Pulse86 bpmStandard Deviation 15
HypnosisMean Pulse84 bpmStandard Deviation 13
Secondary

Non-steroidal Anti-inflammatory Drug Intake

Time frame: day 3

ArmMeasureValue (NUMBER)
ControlNon-steroidal Anti-inflammatory Drug Intake43 participants
HypnosisNon-steroidal Anti-inflammatory Drug Intake18 participants
Secondary

Score at Numeric Pain Rating Scale

The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)

Time frame: just after surgery, up to 1 hour

ArmMeasureValue (MEAN)Dispersion
ControlScore at Numeric Pain Rating Scale2.0 units on a scaleStandard Deviation 1.9
HypnosisScore at Numeric Pain Rating Scale1.3 units on a scaleStandard Deviation 1.4
Secondary

Score at Numeric Pain Rating Scale

The numeric pain rating scale range from 0 (no pain) to 10 (worst pain imaginable)

Time frame: day 3

ArmMeasureValue (MEAN)Dispersion
ControlScore at Numeric Pain Rating Scale1.1 units on a scaleStandard Deviation 1.6
HypnosisScore at Numeric Pain Rating Scale1.1 units on a scaleStandard Deviation 1.1
Secondary

Score at Numeric Pain Rating Scale

The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)

Time frame: day 1

ArmMeasureValue (MEAN)Dispersion
ControlScore at Numeric Pain Rating Scale2.1 units on a scaleStandard Deviation 1.4
HypnosisScore at Numeric Pain Rating Scale2.1 units on a scaleStandard Deviation 1.1
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.

Time frame: Day 3

ArmMeasureValue (MEAN)Dispersion
ControlWellbeing Measured Using a Comfort Scale8.9 units on a scaleStandard Deviation 1.4
HypnosisWellbeing Measured Using a Comfort Scale8.8 units on a scaleStandard Deviation 1.2
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.

Time frame: Day 2

ArmMeasureValue (MEAN)Dispersion
ControlWellbeing Measured Using a Comfort Scale7.8 units on a scaleStandard Deviation 1.5
HypnosisWellbeing Measured Using a Comfort Scale8.0 units on a scaleStandard Deviation 1.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026