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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preferred music listening
Relaxation breathing narrative over hypnotic music listening
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring music listening, Prostate Cancer, anxiety, pain management, postoperative

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Preferred music listening

Hypnotic music with relaxation breathing

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in anxiety as assessed by Spielberg STAI Questionnaire
The Spielberg STAI Questionnaire has a score range of 20-80, with higher scores indicating greater anxiety.
Change in pain score
Pain will be assessed on a 0-10 scale with higher scores signifying more pain.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2020
Last Updated
October 5, 2021
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04596917
Brief Title
Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention
Official Title
Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention After Laparoscopic Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 6, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
music listening, Prostate Cancer, anxiety, pain management, postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 narrative
Masking
ParticipantCare ProviderInvestigator
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
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preferred music listening
Arm Type
Experimental
Arm Description
Patients will be randomized to listen to music with iPod that has preferred music selections that patients can choose.
Arm Title
Hypnotic music with relaxation breathing
Arm Type
Experimental
Arm Description
Patients will be randomized to listen to hypnotic music with relaxation breathing narrative.
Intervention Type
Behavioral
Intervention Name(s)
Preferred music listening
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation breathing narrative over hypnotic music listening
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in anxiety as assessed by Spielberg STAI Questionnaire
Description
The Spielberg STAI Questionnaire has a score range of 20-80, with higher scores indicating greater anxiety.
Time Frame
Baseline and at recovery from PACU, up to 120 minutes
Title
Change in pain score
Description
Pain will be assessed on a 0-10 scale with higher scores signifying more pain.
Time Frame
Baseline and at recovery from PACU, up to 120 minutes

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
men between the ages of 45 to 80 years and who are scheduled for laparoscopic radical prostatectomy surgery will be recruited.
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myrna E Mamaril, DNP
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27085561
Citation
Cho SW, Choi HJ. Effect of Music on Reducing Anxiety for Patients Undergoing Transrectal Ultrasound-Guided Prostate Biopsies: Randomized Prospective Trial. Urol J. 2016 Apr 16;13(2):2612-4.
Results Reference
background
PubMed Identifier
29570546
Citation
Gallagher LM, Gardner V, Bates D, Mason S, Nemecek J, DiFiore JB, Bena J, Li M, Bethoux F. Impact of Music Therapy on Hospitalized Patients Post-Elective Orthopaedic Surgery: A Randomized Controlled Trial. Orthop Nurs. 2018 Mar/Apr;37(2):124-133. doi: 10.1097/NOR.0000000000000432.
Results Reference
background
PubMed Identifier
19962104
Citation
Engwall M, Duppils GS. Music as a nursing intervention for postoperative pain: a systematic review. J Perianesth Nurs. 2009 Dec;24(6):370-83. doi: 10.1016/j.jopan.2009.10.013.
Results Reference
background
PubMed Identifier
29236636
Citation
Barnett ML, Gray J, Zink A, Jena AB. Coupling Policymaking with Evaluation - The Case of the Opioid Crisis. N Engl J Med. 2017 Dec 14;377(24):2306-2309. doi: 10.1056/NEJMp1710014. No abstract available.
Results Reference
background
PubMed Identifier
26277246
Citation
Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12. Erratum In: Lancet. 2015 Oct 24;386(10004):1630.
Results Reference
background
PubMed Identifier
24661440
Citation
Kohler N, Friedrich M, Gansera L, Holze S, Thiel R, Roth S, Rebmann U, Stolzenburg JU, Truss MC, Fahlenkamp D, Scholz HJ, Brahler E. Psychological distress and adjustment to disease in patients before and after radical prostatectomy. Results of a prospective multi-centre study. Eur J Cancer Care (Engl). 2014 Nov;23(6):795-802. doi: 10.1111/ecc.12186. Epub 2014 Feb 13.
Results Reference
background
PubMed Identifier
26365452
Citation
Liu Y, Petrini MA. Effects of music therapy on pain, anxiety, and vital signs in patients after thoracic surgery. Complement Ther Med. 2015 Oct;23(5):714-8. doi: 10.1016/j.ctim.2015.08.002. Epub 2015 Aug 4.
Results Reference
background
PubMed Identifier
30281167
Citation
Maggi M, Gentilucci A, Salciccia S, Gatto A, Gentile V, Colarieti A, Von Heland M, Busetto GM, Del Giudice F, Sciarra A. Psychological impact of different primary treatments for prostate cancer: A critical analysis. Andrologia. 2019 Feb;51(1):e13157. doi: 10.1111/and.13157. Epub 2018 Oct 3.
Results Reference
background
PubMed Identifier
29153918
Citation
Poulsen MJ, Coto J. Nursing Music Protocol and Postoperative Pain. Pain Manag Nurs. 2018 Apr;19(2):172-176. doi: 10.1016/j.pmn.2017.09.003. Epub 2017 Nov 16.
Results Reference
background
PubMed Identifier
7976480
Citation
Miller WL, Crabtree BF. Qualitative analysis: how to begin making sense. Fam Pract Res J. 1994 Sep;14(3):289-97.
Results Reference
background
PubMed Identifier
10940958
Citation
Sandelowski M. Whatever happened to qualitative description? Res Nurs Health. 2000 Aug;23(4):334-40. doi: 10.1002/1098-240x(200008)23:43.0.co;2-g.
Results Reference
background
PubMed Identifier
29463240
Citation
Schmid W, Rosland JH, von Hofacker S, Hunskar I, Bruvik F. Patient's and health care provider's perspectives on music therapy in palliative care - an integrative review. BMC Palliat Care. 2018 Feb 20;17(1):32. doi: 10.1186/s12904-018-0286-4.
Results Reference
background
PubMed Identifier
1635551
Citation
Nishizaki T, Sumikawa K. Tunicamycin increases desensitization of junctional and extrajunctional acetylcholine receptors expressed in Xenopus oocytes by a mechanism independent of N-glycosylation blocking. Mol Pharmacol. 1992 Jul;42(1):152-6.
Results Reference
background
PubMed Identifier
29468607
Citation
Bandaragoda T, Ranasinghe W, Adikari A, de Silva D, Lawrentschuk N, Alahakoon D, Persad R, Bolton D. The Patient-Reported Information Multidimensional Exploration (PRIME) Framework for Investigating Emotions and Other Factors of Prostate Cancer Patients with Low Intermediate Risk Based on Online Cancer Support Group Discussions. Ann Surg Oncol. 2018 Jun;25(6):1737-1745. doi: 10.1245/s10434-018-6372-2. Epub 2018 Feb 21.
Results Reference
background

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

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