Benefits of cardiac coherence combined with medical hypnosis on preoperative anxiety before cancer surgery: the COHEC II study trial protocol
Introduction Preoperative anxiety is a frequent problem that can lead to complications both during anaesthesia and in the postoperative period, especially in oncology. Studies have shown that it can be managed using non-pharmacological approaches, but few works have evaluated psychoeducational progr...
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BMJ Publishing Group
2023-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/12/e072215.full |
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| author | Marta Jarlier Régis Fuzier Gilles Leclerc Catherine Fiess Jibba Amraoui Lauriane Bordenave Geneviève Salvignol Laurent Philibert Célia Touraine |
| author_facet | Marta Jarlier Régis Fuzier Gilles Leclerc Catherine Fiess Jibba Amraoui Lauriane Bordenave Geneviève Salvignol Laurent Philibert Célia Touraine |
| author_sort | Marta Jarlier |
| collection | DOAJ |
| description | Introduction Preoperative anxiety is a frequent problem that can lead to complications both during anaesthesia and in the postoperative period, especially in oncology. Studies have shown that it can be managed using non-pharmacological approaches, but few works have evaluated psychoeducational programmes. The aim of the COHErence Cardiaque (COHEC) II Study is to evaluate the combination of medical hypnosis (MH) and cardiac coherence (CC) training to manage preoperative anxiety in patients with cancer.Methods and analysis COHEC II is an ongoing multicentre randomised clinical trial carried out in three French comprehensive cancer centres. In total, 296 patients who will undergo surgery for cancer will be recruited during 18 months and will be randomised in the control arm or the intervention arm. Patients in the intervention arm will follow a daily programme that combines MH and CC, starting 7 days before surgery. The control arm will receive the standard treatment to manage preoperative anxiety. The primary endpoint is the anxiety level on surgery day, measured using a Visual Analogue Scale. Secondary endpoints are patient adherence to the programme, satisfaction and postsurgery recovery quality.Ethics and dissemination The study protocol was approved by the French Ethics Committee (Comité de Protection des Personnes EST-II) on 24 November 2021 and will be carried out following the good practice guidelines and the Declaration of Helsinki. Results will be published in peer-reviewed journals and presented at conferences.Trial registration number NCT05197972. |
| format | Article |
| id | doaj-art-6586b8ce95c94cb4b83f915bb68cc7a2 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-6586b8ce95c94cb4b83f915bb68cc7a22025-08-20T03:52:16ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2023-072215Benefits of cardiac coherence combined with medical hypnosis on preoperative anxiety before cancer surgery: the COHEC II study trial protocolMarta Jarlier0Régis Fuzier1Gilles Leclerc2Catherine Fiess3Jibba Amraoui4Lauriane Bordenave5Geneviève Salvignol6Laurent Philibert7Célia Touraine8University of Montpellier, Montpellier, FranceIUCT Oncopole, Toulouse, FranceDepartment of Anaesthesia, Montpellier Cancer Institute, University of Montpellier, Montpellier, FranceClinical Research and Innovation Department, Montpellier Cancer Institute, University of Montpellier, Montpellier, FranceDepartment of Anaesthesia, Montpellier Cancer Institute, University of Montpellier, Montpellier, FranceGustave Roussy Institute, Villejuif, FranceIUCT Oncopole, Toulouse, FranceDepartment of Pharmacy, Montpellier Cancer Institute, University of Montpellier, Montpellier, FranceBiometrics Unit, Montpellier Cancer Institute, University of Montpellier, Montpellier, FranceIntroduction Preoperative anxiety is a frequent problem that can lead to complications both during anaesthesia and in the postoperative period, especially in oncology. Studies have shown that it can be managed using non-pharmacological approaches, but few works have evaluated psychoeducational programmes. The aim of the COHErence Cardiaque (COHEC) II Study is to evaluate the combination of medical hypnosis (MH) and cardiac coherence (CC) training to manage preoperative anxiety in patients with cancer.Methods and analysis COHEC II is an ongoing multicentre randomised clinical trial carried out in three French comprehensive cancer centres. In total, 296 patients who will undergo surgery for cancer will be recruited during 18 months and will be randomised in the control arm or the intervention arm. Patients in the intervention arm will follow a daily programme that combines MH and CC, starting 7 days before surgery. The control arm will receive the standard treatment to manage preoperative anxiety. The primary endpoint is the anxiety level on surgery day, measured using a Visual Analogue Scale. Secondary endpoints are patient adherence to the programme, satisfaction and postsurgery recovery quality.Ethics and dissemination The study protocol was approved by the French Ethics Committee (Comité de Protection des Personnes EST-II) on 24 November 2021 and will be carried out following the good practice guidelines and the Declaration of Helsinki. Results will be published in peer-reviewed journals and presented at conferences.Trial registration number NCT05197972.https://bmjopen.bmj.com/content/13/12/e072215.full |
| spellingShingle | Marta Jarlier Régis Fuzier Gilles Leclerc Catherine Fiess Jibba Amraoui Lauriane Bordenave Geneviève Salvignol Laurent Philibert Célia Touraine Benefits of cardiac coherence combined with medical hypnosis on preoperative anxiety before cancer surgery: the COHEC II study trial protocol BMJ Open |
| title | Benefits of cardiac coherence combined with medical hypnosis on preoperative anxiety before cancer surgery: the COHEC II study trial protocol |
| title_full | Benefits of cardiac coherence combined with medical hypnosis on preoperative anxiety before cancer surgery: the COHEC II study trial protocol |
| title_fullStr | Benefits of cardiac coherence combined with medical hypnosis on preoperative anxiety before cancer surgery: the COHEC II study trial protocol |
| title_full_unstemmed | Benefits of cardiac coherence combined with medical hypnosis on preoperative anxiety before cancer surgery: the COHEC II study trial protocol |
| title_short | Benefits of cardiac coherence combined with medical hypnosis on preoperative anxiety before cancer surgery: the COHEC II study trial protocol |
| title_sort | benefits of cardiac coherence combined with medical hypnosis on preoperative anxiety before cancer surgery the cohec ii study trial protocol |
| url | https://bmjopen.bmj.com/content/13/12/e072215.full |
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