NCT03651310

Brief Summary

Can music listening decrease a patient's anxiety before surgery? The investigators hypothesize that music listening will decrease a patient's pre-operative anxiety significantly more than no music listening. The investigators aim to see if additional variables affect a patient's anxiety and response to music listening, such as demographic factors (age, race, prior surgical experience, type of surgery planned) and music background (experience playing a musical instrument, music listening habits). The investigators also aim to see if pre-operative music listening is associated with improved patient satisfaction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

1.1 years

First QC Date

August 23, 2018

Last Update Submit

December 4, 2019

Conditions

Preoperative Anxiety

Outcome Measures

Primary Outcomes (1)

  • Preoperative Anxiety

    The primary variable is anxiety score measured by the State-Trait Anxiety Inventory form Y1 (STAI-Y1) The STAI-Y1 is a 20 item questionnaire which asks subject to rate feelings with a 1-4 pt scale where 1 indicates "not at all" and 4 indicated "very much so". (Range of score 20-80) Higher score equals more anxiety.

    Day 1: 30 minutes

Study Arms (2)

Control Group

NO INTERVENTION

waiting in preoperative area without music listening.

Music Listening Group

ACTIVE COMPARATOR

The music listening group will be given a set of noise canceling headphones and an MP3 player with multiple tracks representing different music genres to use while in preoperative area.

Other: Music Listening Group

Interventions

Music Listening GroupOTHER

Waiting in preoperative area with music listening.

Music Listening Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women who are patients of the Loyola University Medical Center Division of Female Pelvic Medicine and Reconstructive Surgery and are scheduled for pelvic reconstructive surgery.
  • Women who are 18 years and older.
  • There is at least 45 minutes from the time of enrollment to the time patient is transferred to the operating room.

You may not qualify if:

  • Non-English speaking women.
  • Women who are currently pregnant or lactating.
  • Women who are hearing impaired.
  • Women who have participated in this study before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (5)

  • Lee J, Kim HS, Shim KD, Park YS. The Effect of Anxiety, Depression, and Optimism on Postoperative Satisfaction and Clinical Outcomes in Lumbar Spinal Stenosis and Degenerative Spondylolisthesis Patients: Cohort Study. Clin Orthop Surg. 2017 Jun;9(2):177-183. doi: 10.4055/cios.2017.9.2.177. Epub 2017 May 8.

    PMID: 28567219RESULT

  • 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: 23740695RESULT

  • Rosen S, Svensson M, Nilsson U. Calm or not calm: the question of anxiety in the perianesthesia patient. J Perianesth Nurs. 2008 Aug;23(4):237-46. doi: 10.1016/j.jopan.2008.05.002.

    PMID: 18657759RESULT

  • Wang TF, Wu YT, Tseng CF, Chou C. Associations between dental anxiety and postoperative pain following extraction of horizontally impacted wisdom teeth: A prospective observational study. Medicine (Baltimore). 2017 Nov;96(47):e8665. doi: 10.1097/MD.0000000000008665.

    PMID: 29381942RESULT

  • Chen YB, Barnes H, Westbay L, Wolff B, Shannon M, Adams W, Acevedo-Alvarez M, Mueller ER, Pham TT. Preoperative Music Listening in Pelvic Reconstructive Surgery: A Randomized Trial. Female Pelvic Med Reconstr Surg. 2021 Aug 1;27(8):469-473. doi: 10.1097/SPV.0000000000001070.

    PMID: 34397606DERIVED

Study Officials

  • Thythy Pham, MD

    Loyola University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Assistant Professor

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 29, 2018

Study Start

May 29, 2018

Primary Completion

July 15, 2019

Study Completion

September 30, 2019

Last Updated

December 5, 2019

Record last verified: 2019-12

Locations

US(1)