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

NCT04596917 | Completed

• 1 other identifier: IRB00200771
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

music listening; Prostate Cancer; anxiety; pain management; postoperative

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Preferred music listening

EXPERIMENTAL

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

Behavioral: Preferred music listening

Hypnotic music with relaxation breathing

EXPERIMENTAL

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

Behavioral: Relaxation breathing narrative over hypnotic music listening

Interventions

Preferred music listening BEHAVIORAL

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.

Preferred music listening

Relaxation breathing narrative over hypnotic music listening BEHAVIORAL

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.

Hypnotic music with relaxation breathing

Eligibility Criteria

• Age: 45 Years - 80 Years
• Gender Eligibility Details: men between the ages of 45 to 80 years and who are scheduled for laparoscopic radical prostatectomy surgery will be recruited.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (14)

• 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.

  PMID: 27085561 BACKGROUND

• 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.

  PMID: 29570546 BACKGROUND

• 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.

  PMID: 19962104 BACKGROUND

• 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.

  PMID: 29236636 BACKGROUND

• 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.

  PMID: 26277246 BACKGROUND

• 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.

  PMID: 24661440 BACKGROUND

• 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.

  PMID: 26365452 BACKGROUND

• 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.

  PMID: 30281167 BACKGROUND

• 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.

  PMID: 29153918 BACKGROUND

• Miller WL, Crabtree BF. Qualitative analysis: how to begin making sense. Fam Pract Res J. 1994 Sep;14(3):289-97.

  PMID: 7976480 BACKGROUND

• 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.

  PMID: 10940958 BACKGROUND

• 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.

  PMID: 29463240 BACKGROUND

• 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.

  PMID: 1635551 BACKGROUND

• 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.

  PMID: 29468607 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Anxiety Disorders; Agnosia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Myrna E Mamaril, DNP

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized comparative study comparing two types of music listening interventions of preferred music with Spotify compared to hypnotic music with relaxation and breathing narrative

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 22, 2020
• Study Start: October 6, 2020
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)