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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04596917
• Other study ID #: IRB00200771
• Status: Completed
• Phase: N/A
• Start date: October 6, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: October 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (14)

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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. — View 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. Review. — View 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. — View 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. Review. Erratum in: Lancet. 2015 Oct 24;386(10004):1630. — View Citation

Köhler N, Friedrich M, Gansera L, Holze S, Thiel R, Roth S, Rebmann U, Stolzenburg JU, Truss MC, Fahlenkamp D, Scholz HJ, Brähler 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. — View 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. — View 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. Review. — View Citation

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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. Review. — View Citation

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Schmid W, Rosland JH, von Hofacker S, Hunskår 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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and at recovery from PACU, up to 120 minutes
Primary	Change in pain score	Pain will be assessed on a 0-10 scale with higher scores signifying more pain.	Baseline and at recovery from PACU, up to 120 minutes