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 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.

Impact of hypnosis on patient experience after venous access port implantation.

INTRODUCTION: Hypnosis has been reported to decrease pain and anxiety in surgical context, but data studying its impact on patient experience using a validated scale are scarce. In the present study, we assessed the effect of an audio hypnosis session on patient satisfaction during venous access port implantation under local anaesthesia in adult cancer patients using the EVAN-LR Score. METHODS: After informed consent, patients were randomised to receive either hypnosis or standard care. The hypnosis group listened to a 26 minutes recorded audio hypnosis session through the ongoing implantation procedure. The primary outcome was the result of the EVAN-LR questionnaire, assessing perioperative experience in patients undergoing anaesthesia without loss of consciousness. This score describes a global index and 5 dimensions of experience: comfort, pain attention, information and waiting. It is scaled from 0 to 100 with 100 indicating the best possible level of satisfaction. Secondary outcomes included patient's anxiety, heart rate before and after procedure, procedure duration and several Visual Analogic Scale to match EVAN-LR dimensions. RESULTS: Overall, 148 patients were enrolled in the study. The global index of Evan-LR was significantly higher in the hypnosis session group (78 ± 14) compared to the standard care group (71 ± 17) (P = 0.006). No difference was reported in secondary outcomes. CONCLUSION: A recorded audio hypnosis session during subcutaneous venous port implantation under local anaesthesia in cancer patients significantly improved patient satisfaction.