Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT04596917
Collaborator
(none)
77
Enrollment
1
Location
2
Arms
2.8
Actual Duration (Months)
27.6
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Preferred music listening
  • Behavioral: Relaxation breathing narrative over hypnotic music listening
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized comparative study comparing two types of music listening interventions of preferred music with Spotify compared to hypnotic music with relaxation and breathing narrativeRandomized comparative study comparing two types of music listening interventions of preferred music with Spotify compared to hypnotic music with relaxation and breathing narrative
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
PI will be working collaboratively with primary nurse. Both PI and primary nurse will maintain nursing personal protective equipment (PPE) standard of care required for the PreOp and PACU units. Prep and PACU nurses will be blinded to type of intervention
Primary Purpose:
Treatment
Official Title:
Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention After Laparoscopic Radical Prostatectomy
Actual Study Start Date :
Oct 6, 2020
Actual Primary Completion Date :
Dec 30, 2020
Actual Study Completion Date :
Dec 30, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Preferred music listening

Patients will be randomized to listen to music with iPod that has preferred music selections that patients can choose.

Behavioral: Preferred music listening
The preferred music listening group will receive 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.

Experimental: Hypnotic music with relaxation breathing

Patients will be randomized to listen to hypnotic music with relaxation breathing narrative.

Behavioral: Relaxation breathing narrative over hypnotic music listening
The relaxation breathing group will receive the relaxation and breathing instructions over soft monotone hypnotic music in the PreOp unit before surgery and then in the PACU once cognitively ready to listen to the hypnotic music until discharge criteria met.

Outcome Measures

Primary Outcome Measures

  1. Change in anxiety as assessed by Spielberg STAI Questionnaire [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.

  2. Change in pain score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 80 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes

Inclusion Criteria

  • All adult male patients schedule to have a laparoscopic radical prostatectomy surgery who are ages 45 to 80 years of age

  • All ethnic backgrounds

  • All religions

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Johns Hopkins HospitalBaltimoreMarylandUnited States21287

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

  • Principal Investigator: Myrna E Mamaril, DNP, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04596917
Other Study ID Numbers:
  • IRB00200771
First Posted:
Oct 22, 2020
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021