Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03651310
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Thythy Pham, Loyola University

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.


Condition or disease Intervention/treatment Phase
Preoperative Anxiety Other: Music Listening Group Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Music Listening on Preoperative Anxiety in Female Pelvic Medicine and Reconstructive Surgery: A Randomized Trial
Actual Study Start Date : May 29, 2018
Actual Primary Completion Date : July 15, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: Control Group
waiting in preoperative area without music listening.
Active Comparator: 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.
Other: Music Listening Group
Waiting in preoperative area with music listening.




Primary Outcome Measures :
  1. Preoperative Anxiety [ Time Frame: Day 1: 30 minutes ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651310


Locations
Layout table for location information
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Investigators
Layout table for investigator information
Principal Investigator: Thythy Pham, MD Loyola University
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Thythy Pham, MD, Assistant Professor, Loyola University
ClinicalTrials.gov Identifier: NCT03651310    
Other Study ID Numbers: 211003
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Anxiety Disorders
Mental Disorders