Hypnosis With Cardiac SurgeryOCEANICNCT06059976
HYPNOSIS DURING PERIOPERATIVE CARDIAC SURGERY
An observational study of Hypnosis With Cardiac Surgery, run by University Hospital, Grenoble at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypnosis With Cardiac Surgery
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2023to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Adult, Older adult
Study population: Patients hospitalised for cardiac surgery who received hypnosis sessions in cardiac surgery at their request.
Who may be able to join
- > 18 years
- Patients undergoing major cardiac surgery
- Patients who have had perioperative hypnosis sessions.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Delphine Rhem
Grenoble, 38000
DELPHINE G RHEM, drhem@chu-grenoble.fr
Angelina Pollet, 0476766729, apollet@chu-grenoble.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypnosis With Cardiac Surgery
- Keywords
- hypnosis, cardiac surgery, peri operatoire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feelings of patients who received perioperative support using Ericksonian hypnosis during their cardiac surgery treatment.
Perioperative Ericksonian hypnosis satisfaction questionnaire at 6 months and 1 year
Measured: 1 years
Secondary outcomes (3)
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.
Pain scale: EVS / EVA between 0 and 10
Measured: 1 years
Assessment of stress and anxiety in patients receiving hypnosis at 6 months and 1 year.
EVA anxiety scale, satisfaction questionnaire between 0 and 10
Measured: 1 years
Evaluation of quality of life at 6 months and 1 year.
EQ5D5L questionnaire on a scale between 0 and 100
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Jun 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hypnosis With Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059976
- Sponsor's protocol ID
- 2023-A00916-39
- Acronym
- OCEANIC
- Status last verified
- Jul 2024
- First submitted
- 19 Sep 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Ashton RC Jr, Whitworth GC, Seldomridge JA, Shapiro PA, Michler RE, Smith CR, Rose EA, Fisher S, Oz MC. The effects of self-hypnosis on quality of life following coronary artery bypass surgery: preliminary results of a prospective, randomized trial. J Altern Complement Med. 1995 Fall;1(3):285-90. doi: 10.1089/acm.1995.1.285.
PubMed 9395624de Klerk JE, du Plessis WF, Steyn HS, Botha M. Hypnotherapeutic ego strengthening with male South African coronary artery bypass patients. Am J Clin Hypn. 2004 Oct;47(2):79-92. doi: 10.1080/00029157.2004.10403627.
PubMed 15554461Schnur JB, Kafer I, Marcus C, Montgomery GH. HYPNOSIS TO MANAGE DISTRESS RELATED TO MEDICAL PROCEDURES: A META-ANALYSIS. Contemp Hypn. 2008 Aug 21;25(3-4):114-128. doi: 10.1002/ch.364.
PubMed 19746190Akgul A, Guner B, Cirak M, Celik D, Hergunsel O, Bedirhan S. The Beneficial Effect of Hypnosis in Elective Cardiac Surgery: A Preliminary Study. Thorac Cardiovasc Surg. 2016 Oct;64(7):581-588. doi: 10.1055/s-0036-1580623. Epub 2016 Apr 4.
PubMed 27043785Rousseaux F, Dardenne N, Massion PB, Ledoux D, Bicego A, Donneau AF, Faymonville ME, Nyssen AS, Vanhaudenhuyse A. Virtual reality and hypnosis for anxiety and pain management in intensive care units: A prospective randomised trial among cardiac surgery patients. Eur J Anaesthesiol. 2022 Jan 1;39(1):58-66. doi: 10.1097/EJA.0000000000001633.
PubMed 34783683Faymonville EM, Mambourg HP, Joris J, Vrijens B, Fissette J, Albert A, Lamy M. Psychological approaches during conscious sedation. Hypnosis versus stress reducing strategies: a prospective randomized study. Pain. 1997 Dec;73(3):361-367. doi: 10.1016/S0304-3959(97)00122-X.
PubMed 9469526Acikel MET. Evaluation of Depression and Anxiety in Coronary Artery Bypass Surgery Patients: A Prospective Clinical Study. Braz J Cardiovasc Surg. 2019 Aug 27;34(4):389-395. doi: 10.21470/1678-9741-2018-0426.
PubMed 31364347Ashton C Jr, Whitworth GC, Seldomridge JA, Shapiro PA, Weinberg AD, Michler RE, Smith CR, Rose EA, Fisher S, Oz MC. Self-hypnosis reduces anxiety following coronary artery bypass surgery. A prospective, randomized trial. J Cardiovasc Surg (Torino). 1997 Feb;38(1):69-75.
PubMed 9128126
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06059976
- Acronym / sponsor ID
- OCEANIC / 2023-A00916-39
- Conditions
- Hypnosis With Cardiac Surgery
- Keywords
- hypnosis, cardiac surgery, peri operatoire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalised for cardiac surgery who received hypnosis sessions in cardiac surgery at their request.
Key inclusion criteria (3 listed)
- > 18 years
- Patients undergoing major cardiac surgery
- Patients who have had perioperative hypnosis sessions.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Assessment of stress and anxiety in patients receiving hypnosis at 6 months and 1 year.
Time frame: 1 years
Evaluation of quality of life at 6 months and 1 year.
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Results publication: PubMed 9395624Ashton RC Jr, Whitworth GC, Seldomridge JA, Shapiro PA, Michler RE, Smith CR, Rose EA, Fisher S, Oz MC. The effects of self-hypnosis on quality of life following coronary artery bypass surgery: preliminary results of a prospective, randomized trial. J Altern Complement Med. 1995 Fall;1(3):285-90. doi: 10.1089/acm.1995.1.285.
- Results publication: PubMed 15554461de Klerk JE, du Plessis WF, Steyn HS, Botha M. Hypnotherapeutic ego strengthening with male South African coronary artery bypass patients. Am J Clin Hypn. 2004 Oct;47(2):79-92. doi: 10.1080/00029157.2004.10403627.
- Results publication: PubMed 19746190Schnur JB, Kafer I, Marcus C, Montgomery GH. HYPNOSIS TO MANAGE DISTRESS RELATED TO MEDICAL PROCEDURES: A META-ANALYSIS. Contemp Hypn. 2008 Aug 21;25(3-4):114-128. doi: 10.1002/ch.364.
- Results publication: PubMed 27043785Akgul A, Guner B, Cirak M, Celik D, Hergunsel O, Bedirhan S. The Beneficial Effect of Hypnosis in Elective Cardiac Surgery: A Preliminary Study. Thorac Cardiovasc Surg. 2016 Oct;64(7):581-588. doi: 10.1055/s-0036-1580623. Epub 2016 Apr 4.
- Results publication: PubMed 34783683Rousseaux F, Dardenne N, Massion PB, Ledoux D, Bicego A, Donneau AF, Faymonville ME, Nyssen AS, Vanhaudenhuyse A. Virtual reality and hypnosis for anxiety and pain management in intensive care units: A prospective randomised trial among cardiac surgery patients. Eur J Anaesthesiol. 2022 Jan 1;39(1):58-66. doi: 10.1097/EJA.0000000000001633.
- Results publication: PubMed 9469526Faymonville EM, Mambourg HP, Joris J, Vrijens B, Fissette J, Albert A, Lamy M. Psychological approaches during conscious sedation. Hypnosis versus stress reducing strategies: a prospective randomized study. Pain. 1997 Dec;73(3):361-367. doi: 10.1016/S0304-3959(97)00122-X.
- Results publication: PubMed 31364347Acikel MET. Evaluation of Depression and Anxiety in Coronary Artery Bypass Surgery Patients: A Prospective Clinical Study. Braz J Cardiovasc Surg. 2019 Aug 27;34(4):389-395. doi: 10.21470/1678-9741-2018-0426.
- Results publication: PubMed 9128126Ashton C Jr, Whitworth GC, Seldomridge JA, Shapiro PA, Weinberg AD, Michler RE, Smith CR, Rose EA, Fisher S, Oz MC. Self-hypnosis reduces anxiety following coronary artery bypass surgery. A prospective, randomized trial. J Cardiovasc Surg (Torino). 1997 Feb;38(1):69-75.
- Individual participant dataSharing planned: No. 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.
Related trials for Hypnosis With Cardiac Surgery
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypnosis With Cardiac Surgery, run by University Hospital, Grenoble at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Delphine Rhem, doctor (04 76 76 67 29, DRhem@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the feelings of patients who received perioperative support using Ericksonian hypnosis during their cardiac surgery treatment. (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06059976, which also lists 8 linked publications.
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 16 Jul 2024.