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Clinical Trials/NCT04596917
NCT04596917
Completed
Not Applicable

Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention After Laparoscopic Radical Prostatectomy

Johns Hopkins University1 site in 1 country77 target enrollmentOctober 6, 2020
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Johns Hopkins University
Enrollment
77
Locations
1
Primary Endpoint
Change in anxiety as assessed by Spielberg STAI Questionnaire
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

A randomized comparison clinical trial will be conducted in laparoscopic radical prostatectomy patients in the Weinberg PACU at the Johns Hopkins Hospital. 50 patients will be recruited and randomly assigned by a table of random numbers to either the music listening group (n=35) or the relaxation breathing group (n=35).

Detailed Description

Hypothesis: Laparoscopic radical prostatectomy patients who experience music listening will report decreased anxiety scores and improved pain control scores compared with patients listening to relaxation and breathing. Null Hypothesis: There will be no difference in reported anxiety scores and pain control scores between laparoscopic radical prostatectomy patients listening to music versus listening to relaxation and breathing instructions. Music listening participants who meet inclusion criteria will be consented in the PreOp Unit and asked to complete the Spielberg State Trait Anxiety Inventory (STAI) questionnaire. Patient vital signs will be taken and patient will be invited to listen to music study iPod for 15 minutes prior to changing into a hospital gown. Intervention: The music listening group will receive the standard care and a 15 minute patient-preferred music listening selection intervention in the Prep Room and unlimited music listening selection intervention in the PACU once cognitively ready until discharge criteria met. The relaxation breathing group will receive the relaxation and breathing instructions over soft monotone music in the PACU once cognitively ready until discharge criteria met. Results: The experimental music listening group will reveal statistically significant decrease postanesthesia anxiety and pain, while lowering the blood pressure, heart rate and amount of opioids after laparoscopic radical prostatectomy surgery compared to the control group. Conclusion: The findings of the music listening intervention will provide further evidence to support the practice of music listening to decrease postanesthesia anxiety and pain, while lowering the blood pressure, heart rate and amount of opioids after laparoscopic radical prostatectomy surgery.

Registry
clinicaltrials.gov
Start Date
October 6, 2020
End Date
December 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • All patients who do not speak or understand the English language to the extent that it precludes their ability to provide informed consent for the study

Outcomes

Primary Outcomes

Change in anxiety as assessed by Spielberg STAI Questionnaire

Time Frame: Baseline and at recovery from PACU, up to 120 minutes

The Spielberg STAI Questionnaire has a score range of 20-80, with higher scores indicating greater anxiety.

Change in pain score

Time Frame: Baseline and at recovery from PACU, up to 120 minutes

Pain will be assessed on a 0-10 scale with higher scores signifying more pain.

Study Sites (1)

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