Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypnosis | Other | Conversational hypnotic induction and therapeutic suggestions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Wellbeing Measured Using a Comfort Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sandrine DELAVAUX | Groupe Hospitalier de la Rochelle Ré Aunis | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | Posted | Mean | Standard Deviation | units on a scale | just after surgery, up to 1 hour |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mrs Sandrine Delavaux | Groupe Hospitalier de la Rochelle Ré Aunis | +33 5 46 45 50 50 | saniade@msn.com |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 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 |
| Score at Numeric Pain Rating Scale | The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable) | day 1 |
| Score at Numeric Pain Rating Scale | The numeric pain rating scale range from 0 (no pain) to 10 (worst pain imaginable) | day 3 |
| Mean Blood Pressure | preoperative, up to 2 hours |
| Mean Blood Pressure | during surgery (average), up to 2 hours |
| Mean Blood Pressure | for 2 hours in the recovery room at regular intervals (average) |
| Mean Pulse | preoperative, up to 2 hours |
| Mean Pulse | during surgery (average), up to 2 hours |
| Mean Pulse | for 2 hours in the recovery room at regular intervals (average) |
| Non-steroidal Anti-inflammatory Drug Intake | day 3 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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". | Posted | Mean | Standard Deviation | units on a scale | 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". | Posted | Mean | Standard Deviation | units on a scale | Day 3 |
|
|
|
| Secondary | Score at Numeric Pain Rating Scale | The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable) | Posted | Mean | Standard Deviation | units on a scale | 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) | Posted | Mean | Standard Deviation | units on a scale | day 1 |
|
|
|
| Secondary | Score at Numeric Pain Rating Scale | The numeric pain rating scale range from 0 (no pain) to 10 (worst pain imaginable) | Posted | Mean | Standard Deviation | units on a scale | day 3 |
|
|
|
| Secondary | Mean Blood Pressure | Posted | Mean | Standard Deviation | mm Hg | preoperative, up to 2 hours |
|
|
|
| Secondary | Mean Blood Pressure | Posted | Mean | Standard Deviation | mm Hg | during surgery (average), up to 2 hours |
|
|
|
| Secondary | Mean Blood Pressure | Posted | Mean | Standard Deviation | mm Hg | for 2 hours in the recovery room at regular intervals (average) |
|
|
|
| Secondary | Mean Pulse | Posted | Mean | Standard Deviation | bpm | preoperative, up to 2 hours |
|
|
|
| Secondary | Mean Pulse | Posted | Mean | Standard Deviation | bpm | during surgery (average), up to 2 hours |
|
|
|
| Secondary | Mean Pulse | Posted | Mean | Standard Deviation | bpm | for 2 hours in the recovery room at regular intervals (average) |
|
|
|
| Secondary | Non-steroidal Anti-inflammatory Drug Intake | Posted | Number | participants | day 3 |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | 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 | 0 | 35 | 0 | 35 |
Not provided
Not provided
Not provided
| D004191 |
| Behavioral Disciplines and Activities |