Music Interventions During Wide-Awake Hand Surgery

Официальное название

Music Interventions During Wide-Awake Hand Surgery: A Randomized Controlled Trial

Обзор

The purpose of this study is to examine if patients have a lower anxiety level during wide awake hand surgery while listening to their choice of music vs standardized relaxation music. Patients who are planning to undergo wide awake (local anesthetic only hand surgery) and agree to participate will be randomized to either a music intervention where they listen to their choice of music genre or standardized relaxation music during their time in the operating room. 170 participants will be enrolled and can expect to be on study for 2 weeks.

Подробное описание

Music has been shown to decrease anxiety and pain during surgery. Wide awake local anesthesia no tourniquet (WALANT) surgery on the hand is gaining popularity due to efficiency, cost savings and patient safety.

Despite the popularity of WALANT, it still can be anxiety producing even for patients who choose to proceed with surgery without sedation. Music has been shown to decrease anxiety during surgery, but patients' music choices vary widely. The frequency (Hz) of the music intervention has been shown to impact pain reduction, and patient choice of music has been shown to increase sense of control which can decrease anxiety. No study has evaluated the intraoperative effect of patient choice of music vs standardized relaxation music on intraoperative anxiety.

The primary objective of this research is to compare the effect of patient music choice vs standardized relaxation music played during surgery on anxiety levels in patients undergoing WALANT hand surgery. The investigators hypothesize that standardized relaxation music will result in reduced anxiety compared to patient's choice of music.

Вмешательства

• Другое Standardized Relaxation Music
  Participants listen to standardized relaxation music during surgery.
• Другое Personal Choice of Music
  Participants listen to their preferred music during surgery.

Первичные конечные точки

• Change in Visual Analog Scale-Anxiety (VAS-A) Score [Срок оценки: day 0 post-operative, up to day 14]
• Change in State Trait Anxiety Inventory (STAI) Score [Срок оценки: day 0 post-operative, up to day 14]

Вторичные конечные точки (4)

• Participant Heart Rate [Срок оценки: day 0, pre- and intraoperative]
• Participant Systolic Blood Pressure [Срок оценки: pre- and intraoperative on day 0]
• Participant Diastolic Blood Pressure [Срок оценки: pre- and intraoperative on day 0]
• Participant Respiratory Rate [Срок оценки: pre- and intraoperative on day 0]

Критерии участия

Критерии включения

• Adult (18 years of age or older) patients
• Undergoing Wide Awake Local Anesthesia No Tourniquet (WALANT) hand surgery

Критерии исключения

• Patients under the age of 18
• Patients unable to consent for themselves
• Patients unwilling to consent
• Non-English speaking patients
• Patients with significant hearing impairment not able to be corrected with assistive devices

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Wisconsin — Madison

Публикации

• Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17. PMID 29665028
• Palmer JB, Lane D, Mayo D, Schluchter M, Leeming R. Effects of Music Therapy on Anesthesia Requirements and Anxiety in Women Undergoing Ambulatory Breast Surgery for Cancer Diagnosis and Treatment: A Randomized Controlled Trial. J Clin Oncol. 2015 Oct 1;33(28):3162-8. doi: 10.1200/JCO.2014.59.6049. Epub 2015 Aug 17. PMID 26282640
• Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2. PMID 23740695
• Feneberg AC, Kappert MB, Maidhof RM, Doering BK, Olbrich D, Nater UM. Efficacy, Treatment Characteristics, and Biopsychological Mechanisms of Music-Listening Interventions in Reducing Pain (MINTREP): Study Protocol of a Three-Armed Pilot Randomized Controlled Trial. Front Psychiatry. 2020 Nov 4;11:518316. doi: 10.3389/fpsyt.2020.518316. eCollection 2020. PMID 33329075
• Mitchell LA, MacDonald RA. An experimental investigation of the effects of preferred and relaxing music listening on pain perception. J Music Ther. 2006 Winter;43(4):295-316. doi: 10.1093/jmt/43.4.295. PMID 17348757

Идентификаторы

NCT: NCT05472909 · 2022-0674 · Protocol Version 4/7/2023 · A536100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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