Effectiveness of Hypnosis for the Prevention of Anxiety During Coronary Angiography (HYPCOR study): a prospective randomized study.

BACKGROUND: Coronary angiography is the gold standard for the diagnosis of coronary artery disease. This intervention is nevertheless a source of anxiety for the patient both by its discomfort and by the consequences linked to the discovery of potential diseases. OBJECTIVES: The aim of this study was to determine the effectiveness of hypnosis in reducing anxiety in patients undergoing coronary angiography. METHODS: One hundred sixty-nine patients with planned coronary angiography and no history of coronary angiography were randomized to a hypnosis or control group. Patients in the hypnosis group underwent a hypnosis session with self-hypnosis posthypnotic suggestions, while those in the control group had a conversational interview with the hypnotherapist. The primary endpoint was pre-exam anxiety level assessed by the Spielberger State-Trait Anxiety Inventory (STAI-Y A). RESULTS: Performing a hypnosis session did not result in a significant decrease in anxiety before the intervention. Age, high trait anxiety, high state anxiety the day before, and belief that hypnosis works in general were associated with increased anxiety before the procedure. No adverse events were reported after hypnosis. There was no statistically significant difference between the 2 groups for the occurrence of complications of the intervention. CONCLUSION: In this study, performing a hypnosis session before coronary angiography did not reduce the state of anxiety measured just before the intervention. In all cases, the hypnotic experience appears to be positive for the patient, encouraging further research efforts. TRIAL REGISTRATION: The research protocol has been registered on the ClinicalTrials.gov registry (NCT02818101; 29/06/2016) and with the ANSM (IDRCB 2016-A00205-46; 02/02/2016).

Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department - a multicentre, randomised, controlled study protocol.

INTRODUCTION: Anterior shoulder dislocation is a common reason for consultation at the emergency department (ED). Hypnosis could be a safe and effective alternative therapy for pain relief during shoulder dislocation reduction but nowadays, evidence is not sufficient. The main objective of this study is to show that reduction under hypnosis is associated with a decrease in the use of analgesic compared with usual care. METHODS AND ANALYSIS: We will conduct an interventional, controlled, multicentre, randomised study. A total of 44 patients with shoulder dislocation will be randomised in two groups: the hypnosis group (N=22) and the usual care group (N=22). The primary endpoint will be the comparison of morphine equivalent analgesic consumption during a shoulder dislocation reduction manoeuvre. Secondary endpoints will include haemodynamic parameters monitoring, patient and practitioner satisfaction using a Likert scale, use of coanalgesic or sedative drugs, number of reduction attempts and time spent at ED. Adverse events will be recorded. Statistical analysis will include parametric tests, multivariate linear regression and descriptive statistics. ETHICS AND DISSEMINATION: This study has received ethics approval from the Comité de Protection des Personnes of Sud-Est IV on 03/11/2021 (ANSM informed on 19 November 2021). The results will be published in scientific articles and communicated in national and international conferences. TRIAL REGISTRATION NUMBER: ClinicalTrial.gov: NCT04992598; National Clinical trial no ID RCB : 2021-A01382-39.