Anxiety, Cesarean Section, Pain
Conditions
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
Conversational hypnotic induction and therapeutic suggestions
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wellbeing Measured Using a Comfort Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wellbeing Measured Using a Comfort Scale | 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. |
| Score at Numeric Pain Rating Scale | just after surgery, up to 1 hour | The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable) |
| Mean Blood Pressure | preoperative, up to 2 hours | — |
| Mean Pulse | preoperative, up to 2 hours | — |
| Non-steroidal Anti-inflammatory Drug Intake | day 3 | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 79 |
Baseline characteristics
| Characteristic | Control | Hypnosis | Total |
|---|---|---|---|
| Age, Continuous | 30.6 years STANDARD_DEVIATION 5.7 | 31.2 years STANDARD_DEVIATION 5.3 | 30.8 years STANDARD_DEVIATION 5.5 |
| Region of Enrollment France | 44 participants | 35 participants | 79 participants |
| Sex: Female, Male Female | 44 Participants | 35 Participants | 79 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 35 |
| serious Total, serious adverse events | 0 / 44 | 0 / 35 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Wellbeing Measured Using a Comfort Scale | 6.7 units on a scale | Standard Deviation 1.7 |
| Hypnosis | Wellbeing Measured Using a Comfort Scale | 8.0 units on a scale | Standard Deviation 1.4 |
Mean Blood Pressure
Time frame: preoperative, up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Mean Blood Pressure | 96 mm Hg | Standard Deviation 11 |
| Hypnosis | Mean Blood Pressure | 101 mm Hg | Standard Deviation 14 |
Mean Blood Pressure
Time frame: during surgery (average), up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Mean Blood Pressure | 85 mm Hg | Standard Deviation 10 |
| Hypnosis | Mean Blood Pressure | 84 mm Hg | Standard Deviation 10 |
Mean Blood Pressure
Time frame: for 2 hours in the recovery room at regular intervals (average)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Mean Blood Pressure | 87 mm Hg | Standard Deviation 10 |
| Hypnosis | Mean Blood Pressure | 88 mm Hg | Standard Deviation 10 |
Mean Pulse
Time frame: preoperative, up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Mean Pulse | 95 bpm | Standard Deviation 17 |
| Hypnosis | Mean Pulse | 94 bpm | Standard Deviation 17 |
Mean Pulse
Time frame: during surgery (average), up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Mean Pulse | 90 bpm | Standard Deviation 13 |
| Hypnosis | Mean Pulse | 90 bpm | Standard Deviation 15 |
Mean Pulse
Time frame: for 2 hours in the recovery room at regular intervals (average)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Mean Pulse | 86 bpm | Standard Deviation 15 |
| Hypnosis | Mean Pulse | 84 bpm | Standard Deviation 13 |
Non-steroidal Anti-inflammatory Drug Intake
Time frame: day 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Non-steroidal Anti-inflammatory Drug Intake | 43 participants |
| Hypnosis | Non-steroidal Anti-inflammatory Drug Intake | 18 participants |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Score at Numeric Pain Rating Scale | 2.0 units on a scale | Standard Deviation 1.9 |
| Hypnosis | Score at Numeric Pain Rating Scale | 1.3 units on a scale | Standard Deviation 1.4 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Score at Numeric Pain Rating Scale | 1.1 units on a scale | Standard Deviation 1.6 |
| Hypnosis | Score at Numeric Pain Rating Scale | 1.1 units on a scale | Standard Deviation 1.1 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Score at Numeric Pain Rating Scale | 2.1 units on a scale | Standard Deviation 1.4 |
| Hypnosis | Score at Numeric Pain Rating Scale | 2.1 units on a scale | Standard Deviation 1.1 |
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.
Time frame: Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Wellbeing Measured Using a Comfort Scale | 8.9 units on a scale | Standard Deviation 1.4 |
| Hypnosis | Wellbeing Measured Using a Comfort Scale | 8.8 units on a scale | Standard Deviation 1.2 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Wellbeing Measured Using a Comfort Scale | 7.8 units on a scale | Standard Deviation 1.5 |
| Hypnosis | Wellbeing Measured Using a Comfort Scale | 8.0 units on a scale | Standard Deviation 1.5 |