Musikinterventioner under vidvaken handkirurgi
Musikinterventioner under vidvaken handkirurgi: ett randomiserat kontrollerat försök
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Katie Schjei
- Telefonnummer: 608-234-6719
- E-post: Schjei@ortho.wisc.edu
Studieorter
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53705
- Rekrytering
- University of Wisconsin
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adult (18 years of age or older) patients
- Undergoing Wide Awake Local Anesthesia No Tourniquet (WALANT) hand surgery
Exclusion Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Standardiserad avslappningsmusik
|
Participants listen to standardized relaxation music during surgery. |
|
Aktiv komparator: Personligt val av musik
|
Participants listen to their preferred music during surgery. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Visual Analog Scale-Anxiety (VAS-A) Score
Tidsram: day 0 post-operative, up to day 14
|
The VAS-A is scored from 0-10 where 0 is 'feeling calm' and 10 is 'extremely anxious'. |
day 0 post-operative, up to day 14
|
|
Change in State Trait Anxiety Inventory (STAI) Score
Tidsram: day 0 post-operative, up to day 14
|
The STAI is a 20-item questionnaire (form Y-1) scored on a 4 point likert scale where 1 is 'not at all', 2 is 'somewhat', 3 is 'moderately so', and 4 is 'very much so' for a total possible range of scores from 20-80 where higher scores indicate increased anxiety. |
day 0 post-operative, up to day 14
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Deltagares hjärtfrekvens
Tidsram: dag 0, pre- och intraoperativt
|
dag 0, pre- och intraoperativt
|
|
Deltagarens systoliska blodtryck
Tidsram: pre- och intraoperativt dag 0
|
pre- och intraoperativt dag 0
|
|
Deltagarens diastoliska blodtryck
Tidsram: pre- och intraoperativt dag 0
|
pre- och intraoperativt dag 0
|
|
Andningsfrekvens för deltagare
Tidsram: pre- och intraoperativt dag 0
|
pre- och intraoperativt dag 0
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Lisa Kruse, MD, University of Wisconsin, Madison
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2022-0674
- A536100 (Annan identifierare: UW Madison)
- Protocol Version 4/7/2023 (Annan identifierare: UW Madison)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Results will not be shared with patients or their primary care physicians. Study results will be shared via manuscript publication in a peer reviewed journal. Data will be pooled and deidentified. No individual results will be shared.
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