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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

Tiphaine Petot, Nicolas Bouscaren, Olivier Maillard, Laetitia Huiart, Malik Boukerrou, Danielle Reynaud
Trials 2019 January 7, 20 (1): 20
30616674

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.

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