AnxietyNCT05472909
Music Interventions During Wide-Awake Hand Surgery
A study testing Standardized Relaxation Music and Personal Choice of Music in people with Anxiety and Surgery, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Standardized Relaxation Music and Personal Choice of Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 years of age or older) patients
- Undergoing Wide Awake Local Anesthesia No Tourniquet (WALANT) hand surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
About this study
Official title: Music Interventions During Wide-Awake Hand Surgery: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Standardized Relaxation Music, Personal Choice of Music
- Keywords
- wide-awake hand surgery, music intervention, patient care
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Relaxation MusicOther
Participants listen to standardized relaxation music during surgery.
Personal Choice of MusicOther
Participants listen to their preferred music during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Relaxation Music | Experimental | Not described Receives: Other: Standardized Relaxation Music |
| Personal Choice of Music | Active comparator | Not described Receives: Other: Personal Choice of Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale-Anxiety (VAS-A) Score
The VAS-A is scored from 0-10 where 0 is 'feeling calm' and 10 is 'extremely anxious'.
Measured: day 0 post-operative, up to day 14
Change in State Trait Anxiety Inventory (STAI) Score
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.
Measured: day 0 post-operative, up to day 14
Secondary outcomes (4)
Participant Heart Rate
Measured: day 0, pre- and intraoperative
Participant Systolic Blood Pressure
Measured: pre- and intraoperative on day 0
Participant Diastolic Blood Pressure
Measured: pre- and intraoperative on day 0
Participant Respiratory Rate
Measured: pre- and intraoperative on day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study startJan 2027 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Kruse, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472909
- Sponsor's protocol ID
- 2022-0674
- Other IDs
- Protocol Version 4/7/2023, A536100
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2022
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 29665028Palmer 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.
PubMed 26282640Bradt 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.
PubMed 23740695Feneberg 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.
PubMed 33329075Mitchell 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.
PubMed 17348757
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Interventions During Wide-Awake Hand Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05472909
- Acronym / sponsor ID
- 2022-0674
- Keywords
- wide-awake hand surgery, music intervention, patient care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Relaxation Music | Experimental | Other: Standardized Relaxation Music |
| Personal Choice of Music | Active comparator | Other: Personal Choice of Music |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (18 years of age or older) patients
- Undergoing Wide Awake Local Anesthesia No Tourniquet (WALANT) hand surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Relaxation MusicParticipants listen to standardized relaxation music during surgery. | Other | Standardized Relaxation Music |
| Personal Choice of MusicParticipants listen to their preferred music during surgery. | Other | Personal Choice of Music |
Primary outcome
Change in Visual Analog Scale-Anxiety (VAS-A) Score
Time frame: 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'.
Change in State Trait Anxiety Inventory (STAI) Score
Time frame: 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.
4 secondary outcomes
Participant Heart Rate
Time frame: day 0, pre- and intraoperative
Participant Systolic Blood Pressure
Time frame: pre- and intraoperative on day 0
Participant Diastolic Blood Pressure
Time frame: pre- and intraoperative on day 0
Participant Respiratory Rate
Time frame: pre- and intraoperative on day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 29665028Kuhlmann 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.
- Background: PubMed 26282640Palmer 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.
- Background: PubMed 23740695Bradt 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.
- Background: PubMed 33329075Feneberg 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.
- Background: PubMed 17348757Mitchell 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Kruse, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Relaxation Music and Personal Choice of Music in people with Anxiety and Surgery, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Schjei (608-234-6719, Schjei@ortho.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale-Anxiety (VAS-A) Score (time frame: day 0 post-operative, up to day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05472909, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.