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Completed

NCT Number: NCT02418026

Improving Cesarean Section Experience Through Hypnotherapy

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypnosis

Other

Conversational hypnotic induction and therapeutic suggestions

Primary outcomes

  1. Wellbeing Measured Using a Comfort Scale

    Time frame: 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 outcomes

  1. Wellbeing Measured Using a Comfort Scale

    Time frame: 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".

  2. Wellbeing Measured Using a Comfort Scale

    Time frame: 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".

  3. Score at Numeric Pain Rating Scale

    Time frame: just after surgery, up to 1 hour

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

  4. Score at Numeric Pain Rating Scale

    Time frame: day 1

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

  5. Score at Numeric Pain Rating Scale

    Time frame: day 3

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

  6. Mean Blood Pressure

    Time frame: preoperative, up to 2 hours

  7. Mean Blood Pressure

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

  8. Mean Blood Pressure

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

  9. Mean Pulse

    Time frame: preoperative, up to 2 hours

  10. Mean Pulse

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

  11. Mean Pulse

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

  12. Non-steroidal Anti-inflammatory Drug Intake

    Time frame: day 3

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 16, 2015
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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