Cesarean SectionNCT02418026
Improving Cesarean Section Experience Through Hypnotherapy
A study testing hypnosis in people with Cesarean Section and Pain, run by Groupe Hospitalier de la Rochelle Ré Aunis.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section, Pain, Anxiety
- What is being tested?
- hypnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- over 18
- scheduled or unplanned cesarean section
- Informed consent
Who cannot join
- Refusal of the patient to participate in the study
- Not French speaking
- Patients under guardianship
About this study
Official title: Improving Cesarean Section Experience Through Hypnotherapy: a Prospective Single Center Case-control Study
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.
Read the 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.
- Conditions
- Cesarean Section, Pain, Anxiety
- Being tested
- hypnosis
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnosisOther
Conversational hypnotic induction and therapeutic suggestions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: just after surgery, up to 1 hour
Secondary outcomes (12)
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".
Measured: Day 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".
Measured: Day 3
Score at Numeric Pain Rating Scale
The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)
Measured: 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)
Measured: day 1
Score at Numeric Pain Rating Scale
The numeric pain rating scale range from 0 (no pain) to 10 (worst pain imaginable)
Measured: day 3
Mean Blood Pressure
Measured: preoperative, up to 2 hours
Mean Blood Pressure
Measured: during surgery (average), up to 2 hours
Mean Blood Pressure
Measured: for 2 hours in the recovery room at regular intervals (average)
Mean Pulse
Measured: preoperative, up to 2 hours
Mean Pulse
Measured: during surgery (average), up to 2 hours
Mean Pulse
Measured: for 2 hours in the recovery room at regular intervals (average)
Non-steroidal Anti-inflammatory Drug Intake
Measured: day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startFeb 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine DELAVAUX, Principal investigator, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418026
- Sponsor's protocol ID
- 2014/P01/034
- Status last verified
- Jan 2024
- First submitted
- 7 Apr 2015
- Last updated
- 17 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cesarean Section Experience Through Hypnotherapy: a Prospective Single Center Case-control Study
- ClinicalTrials.gov ID
- NCT02418026
- Acronym / sponsor ID
- 2014/P01/034
- Conditions
- Cesarean Section, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Posted 1 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care |
| Hypnosis | Experimental | Other: hypnosiswomen 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- over 18
- scheduled or unplanned cesarean section
- Informed consent
Key exclusion criteria (3 listed)
- Refusal of the patient to participate in the study
- Not French speaking
- Patients under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypnosisConversational hypnotic induction and therapeutic suggestions | Other | Hypnosis |
Primary outcome
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".
12 secondary outcomes
Wellbeing Measured Using a Comfort Scale
Time frame: Day 2
Wellbeing Measured Using a Comfort Scale
Time frame: Day 3
Score at Numeric Pain Rating Scale
Time frame: just after surgery, up to 1 hour
Score at Numeric Pain Rating Scale
Time frame: day 1
Score at Numeric Pain Rating Scale
Time frame: day 3
Mean Blood Pressure
Time frame: preoperative, up to 2 hours
Mean Blood Pressure
Time frame: during surgery (average), up to 2 hours
Mean Blood Pressure
Time frame: for 2 hours in the recovery room at regular intervals (average)
Mean Pulse
Time frame: preoperative, up to 2 hours
Mean Pulse
Time frame: during surgery (average), up to 2 hours
Mean Pulse
Time frame: for 2 hours in the recovery room at regular intervals (average)
Non-steroidal Anti-inflammatory Drug Intake
Time frame: day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cesarean Section
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Not yet recruitingObservational study
Early Heart Rate Variability and Sleep and Quality of Recovery After Cesarean Delivery
Recovery of Function, Postoperative Period
Recruiting
Effects of Rehabilitation on Cesarean Scar Symptoms and Physical Recovery
Cesarean Birth, Massage
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine DELAVAUX principal investigator
Groupe Hospitalier de la Rochelle Ré Aunis
Questions about this trial
What is this clinical trial studying?
A study testing hypnosis in people with Cesarean Section and Pain, run by Groupe Hospitalier de la Rochelle Ré Aunis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wellbeing Measured Using a Comfort Scale (time frame: just after surgery, up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.