Comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery: a study protocol for a randomised controlled trial

Abstract

BACKGROUND: Patients undergoing gynaecological surgery are known to experience anxiety. While the use of music selected by patients based on their personal taste has hardly been evaluated, a recent study suggests that musical preferences significantly alter the anxiolytic and relaxing effects of music. Our study aims to determine whether self-selected music decreases patient anxiety prior to gynaecological surgery, as compared with predetermined music from a software programme such as MUSIC CARE®. METHODS: The study will consist of a clinical trial comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery. A minimum of 170 patients will be randomised in a 1:1 ratio. Inclusion criteria will be: women aged 18-55 years, awaiting scheduled gynaecological surgery under general/local anaesthesia or under sedation; having created a personal 20-min playlist; and not having received anxiolytic drugs prior to surgery. The primary outcome will be the difference between the preoperative anxiety score taken 15 to 20 min before the music-listening session and the preoperative anxiety score taken shortly after the session, as measured with the STAI for state anxiety. DISCUSSION: This study should help to identify more effective non-medical treatments for preoperative anxiety, as well as to adapt music therapy to the cultural context of patients. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03226834 . Registered on 24 July 2017.