HYPNOSIS DURING PERIOPERATIVE CARDIAC SURGERY (OCEANIC)

September 26, 2023 updated by: University Hospital, Grenoble

EVALUATION OF PRACTICES: RETROSPECTIVE AND PROSPECTIVE MONOCENTRIC SURVEY ON THE SATISFACTION OF PATIENTS UNDERGOING CARDIAC SURGERY WHO WERE ABLE TO BENEFIT FROM ADDITIONAL MANAGEMENT BY ERICKSONIAN MEDICAL HYPNOSIS DURING THEIR STAY.

Evaluation of practices: retrospective and prospective monocentric survey on the satisfaction of patients undergoing Cardiac Surgery who were able to benefit from additional management by Ericksonian Medical Hypnosis during their stay.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Since 2018, additional care using Ericksonian Medical Hypnosis has been offered to patients undergoing cardiac surgery. Cardiac surgery is one of the most complex and high-risk procedures, requiring a general anaesthetic and a stay in intensive care.

Its aim is to reduce pre-operative stress and anxiety, which are always present to varying degrees before this type of treatment. The aim is to put the patient back at the centre of his or her care by making them active and active participants throughout the treatment process.

Many studies have demonstrated the benefits of hypnosis in reducing anxiety, depression, pain perception, sedation and comfort during hospitalisation. However, very few studies have looked at the quality of life of these patients for up to a year.

Hypnosis support is subject to the number and presence of trained nursing staff.

In order to assess the feelings of patients who have benefited from this additional treatment, and to improve our practices, we would like to carry out a satisfaction survey using questionnaires including the EQ5D-5L quality of life questionnaire.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients hospitalised for cardiac surgery who received hypnosis sessions in cardiac surgery at their request.

Description

Inclusion Criteria:

  • > 18 years
  • Patients undergoing major cardiac surgery
  • Patients who have had perioperative hypnosis sessions.

Exclusion Criteria:

  • Opposition of the patient to the conservation of data
  • Subject under guardianship or subject deprived of liberty, as referred to in articles L1121-5 to L1121-8 of the CSP (French Public Health Code)
  • Pregnant or breast-feeding women
  • Contraindication to the practice of hypnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hypnosis

Inclusion of patients undergoing major cardiac surgery who have received perioperative hypnosis sessions from January 2023.

After obtaining their consent to participate in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the feelings of patients who received perioperative support using Ericksonian hypnosis during their cardiac surgery treatment.
Time Frame: 1 years
Perioperative Ericksonian hypnosis satisfaction questionnaire at 6 months and 1 year
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of pain in patients receiving hypnosis sessions in cardiac surgery on the day of discharge from hospital, at 6 months and at 1 year.
Time Frame: 1 years
Pain scale: EVS / EVA between 0 and 10
1 years
Assessment of stress and anxiety in patients receiving hypnosis at 6 months and 1 year.
Time Frame: 1 years
EVA anxiety scale, satisfaction questionnaire between 0 and 10
1 years
Evaluation of quality of life at 6 months and 1 year.
Time Frame: 1 years
EQ5D5L questionnaire on a scale between 0 and 100
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-A00916-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Analyses of the primary and secondary endpoints will be descriptive. Continuous variables will be described using the mean and standard deviation, as well as the median and interquartile range. Qualitative variables will be described in terms of numbers and associated percentages.

All analyses will be carried out on a frozen database, in accordance with current good practice at Grenoble Alpes University Hospital.

The analyses will be carried out under the supervision of a statistical engineer from the Data Engineering Unit.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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