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Music Listening on Preoperative Anxiety in Female Pelvic Medicine and Reconstructive Surgery

Primary Purpose

Preoperative Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Listening Group
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preoperative Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group

Music Listening Group

Arm Description

waiting in preoperative area without music listening.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2018
Last Updated
December 4, 2019
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT03651310
Brief Title
Music Listening on Preoperative Anxiety in Female Pelvic Medicine and Reconstructive Surgery
Official Title
The Effect of Music Listening on Preoperative Anxiety in Female Pelvic Medicine and Reconstructive Surgery: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Does music listening decrease preoperative anxiety in women who are scheduled for pelvic reconstructive surgery? Participants will be approached on the day of pelvic reconstructive surgery while they wait in the pre-operative area for surgery. For the sake of not disrupting the flow of the surgery schedule, patients will be consented approximately 45 minutes before the anticipated start time of surgery. If patient agrees to participate, they will be consented and evaluated for eligibility. Once informed consent is obtained, the patient will be randomized to either the music listening group or the control group. All patients will be asked to complete a STAI-Y1 and demographics questionnaire while awaiting surgery. Those in the music listening group will be asked to answer additional questions regarding their background and experience with music. Control group: Participants in the control group will complete another STAI-Y1 questionnaire after 30 minutes of waiting. At the patient's routine 6 weeks postoperative visit, she will be asked to rate her overall satisfaction with her surgery and her satisfaction with the preoperative experience. Music listening group: 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. Patients will be given a handout listing the music genre types and asked to circle which music type they listened to during the study. Genre types include classical instrumental, classical piano, smooth jazz, gospel, and new age. After 30 minutes, patients will be asked to complete another STAI-Y1 questionnaire. They will be given the option to continue listening to music up until the time of surgery; however no additional STAI-Y1 questionnaires will be administered. Headphones and the MP3 player will be taken from the patient as she is being transported to the operating room. The headphones and MP3 player will be cleaned with alcohol wipes and reused for other participants in the study. At the patient's routine 6 weeks postoperative visit, she will be asked to rate her overall satisfaction with her surgery, her satisfaction with the preoperative experience, and whether she would recommend pre-operative music listening to others.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preoperative Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
waiting in preoperative area without music listening.
Arm Title
Music Listening Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Music Listening Group
Intervention Description
Waiting in preoperative area with music listening.
Primary Outcome Measure Information:
Title
Preoperative Anxiety
Description
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.
Time Frame
Day 1: 30 minutes

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Non-English speaking women. Women who are currently pregnant or lactating. Women who are hearing impaired. Women who have participated in this study before.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thythy Pham, MD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28567219
Citation
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.
Results Reference
result
PubMed Identifier
23740695
Citation
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.
Results Reference
result
PubMed Identifier
18657759
Citation
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.
Results Reference
result
PubMed Identifier
29381942
Citation
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.
Results Reference
result
PubMed Identifier
34397606
Citation
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.
Results Reference
derived

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Music Listening on Preoperative Anxiety in Female Pelvic Medicine and Reconstructive Surgery

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