Trial Outcomes & Findings for Improving Cesarean Section Experience Through Hypnotherapy (NCT NCT02418026)

NCT ID: NCT02418026

Last Updated: 2024-01-17

Results Overview

The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to "no comfort" and 10 corresponds to "most comfortable".

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 79 participants
• Primary outcome timeframe: just after surgery, up to 1 hour
• Results posted on: 2024-01-17

Participant Flow

Participant milestones

Measure	Control women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	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
Overall Study STARTED	44	35
Overall Study COMPLETED	44	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Cesarean Section Experience Through Hypnotherapy

Baseline characteristics by cohort

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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	Total n=79 Participants Total of all reporting groups
Age, Continuous	30.6 years STANDARD_DEVIATION 5.7 • n=5 Participants	31.2 years STANDARD_DEVIATION 5.3 • n=7 Participants	30.8 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	35 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment France	44 participants n=5 Participants	35 participants n=7 Participants	79 participants n=5 Participants

PRIMARY outcome

Timeframe: 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".

Outcome measures

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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
Wellbeing Measured Using a Comfort Scale	6.7 units on a scale Standard Deviation 1.7	8.0 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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".

Outcome measures

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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
Wellbeing Measured Using a Comfort Scale	7.8 units on a scale Standard Deviation 1.5	8.0 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Day 3

The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to "no comfort" and 10 corresponds to "most comfortable".

Outcome measures

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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
Wellbeing Measured Using a Comfort Scale	8.9 units on a scale Standard Deviation 1.4	8.8 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: just after surgery, up to 1 hour

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

Outcome measures

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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
Score at Numeric Pain Rating Scale	2.0 units on a scale Standard Deviation 1.9	1.3 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: day 1

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

Outcome measures

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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
Score at Numeric Pain Rating Scale	2.1 units on a scale Standard Deviation 1.4	2.1 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: day 3

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

Outcome measures

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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
Score at Numeric Pain Rating Scale	1.1 units on a scale Standard Deviation 1.6	1.1 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: preoperative, up to 2 hours

Outcome measures

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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
Mean Blood Pressure	96 mm Hg Standard Deviation 11	101 mm Hg Standard Deviation 14

SECONDARY outcome

Timeframe: during surgery (average), up to 2 hours

Outcome measures

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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
Mean Blood Pressure	85 mm Hg Standard Deviation 10	84 mm Hg Standard Deviation 10

SECONDARY outcome

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

Outcome measures

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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
Mean Blood Pressure	87 mm Hg Standard Deviation 10	88 mm Hg Standard Deviation 10

SECONDARY outcome

Timeframe: preoperative, up to 2 hours

Outcome measures

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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
Mean Pulse	95 bpm Standard Deviation 17	94 bpm Standard Deviation 17

SECONDARY outcome

Timeframe: during surgery (average), up to 2 hours

Outcome measures

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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
Mean Pulse	90 bpm Standard Deviation 13	90 bpm Standard Deviation 15

SECONDARY outcome

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

Outcome measures

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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
Mean Pulse	86 bpm Standard Deviation 15	84 bpm Standard Deviation 13

SECONDARY outcome

Timeframe: day 3

Outcome measures

Measure	Control n=44 Participants women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care	Hypnosis n=35 Participants 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
Non-steroidal Anti-inflammatory Drug Intake	43 participants	18 participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hypnosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mrs Sandrine Delavaux

Groupe Hospitalier de la Rochelle Ré Aunis

Phone: +33 5 46 45 50 50

Email: saniade@msn.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place