Prostate CancerNCT04596917
Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention
A study testing Preferred music listening and Relaxation breathing narrative over hypnotic music listening in people with Prostate Cancer, run by Johns Hopkins University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 45 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Preferred music listening and Relaxation breathing narrative over hypnotic music listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention After Laparoscopic Radical Prostatectomy
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).
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Preferred music listening, Relaxation breathing narrative over hypnotic music listening
- Keywords
- music listening, Prostate Cancer, anxiety, pain management, postoperative
- Medical subject headings
- Prostatic Neoplasms, Anxiety Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preferred music listeningBehavioural
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 listeningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Preferred music listening | Experimental | Patients will be randomized to listen to music with iPod that has preferred music selections that patients can choose. Receives: Behavioral: Preferred music listening |
| Hypnotic music with relaxation breathing | Experimental | Patients will be randomized to listen to hypnotic music with relaxation breathing narrative. Receives: Behavioral: Relaxation breathing narrative over hypnotic music listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and at recovery from PACU, up to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start6 Oct 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Myrna E Mamaril, DNP, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596917
- Sponsor's protocol ID
- IRB00200771
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2020
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27085561Gallagher 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.
PubMed 29570546Engwall 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.
PubMed 19962104Barnett 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.
PubMed 29236636Hole 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.
PubMed 26277246Kohler 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.
PubMed 24661440Liu 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.
PubMed 26365452Maggi 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.
PubMed 30281167Poulsen 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.
PubMed 29153918Miller WL, Crabtree BF. Qualitative analysis: how to begin making sense. Fam Pract Res J. 1994 Sep;14(3):289-97.
PubMed 7976480Sandelowski 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.
PubMed 10940958Schmid 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.
PubMed 29463240Nishizaki 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.
PubMed 1635551Bandaragoda 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.
PubMed 29468607
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Listening as a Postanesthesia Care Unit (PACU) Nursing Intervention After Laparoscopic Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT04596917
- Acronym / sponsor ID
- IRB00200771
- Conditions
- Prostate Cancer
- Keywords
- music listening, Prostate Cancer, anxiety, pain management, postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Preferred music listening | Experimental | Behavioral: Preferred music listeningPatients will be randomized to listen to music with iPod that has preferred music selections that patients can choose. |
| Hypnotic music with relaxation breathing | Experimental | Behavioral: Relaxation breathing narrative over hypnotic music listeningPatients will be randomized to listen to hypnotic music with relaxation breathing narrative. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preferred music listeningThe 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. | Behavioural | Preferred music listening |
| Relaxation breathing narrative over hypnotic music listeningThe 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. | Behavioural | Hypnotic music with relaxation breathing |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Background: PubMed 27085561Cho 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.
- Background: PubMed 29570546Gallagher 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.
- Background: PubMed 19962104Engwall 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.
- Background: PubMed 29236636Barnett 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.
- Background: PubMed 26277246Hole 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.
- Background: PubMed 24661440Kohler 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.
- Background: PubMed 26365452Liu 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.
- Background: PubMed 30281167Maggi 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.
- Background: PubMed 29153918Poulsen 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.
- Background: PubMed 7976480Miller WL, Crabtree BF. Qualitative analysis: how to begin making sense. Fam Pract Res J. 1994 Sep;14(3):289-97.
- Background: PubMed 10940958Sandelowski 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.
- Background: PubMed 29463240Schmid 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.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myrna E Mamaril, DNP principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preferred music listening and Relaxation breathing narrative over hypnotic music listening in people with Prostate Cancer, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety as assessed by Spielberg STAI Questionnaire (time frame: Baseline and at recovery from PACU, up to 120 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04596917, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.