Effect of live music on anxiety and depression in cancer inpatients
| ISRCTN | ISRCTN28383230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28383230 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 1 |
| Sponsor | Cooper University Hospital |
| Funder | Investigator initiated and funded |
- Submission date
- 19/08/2022
- Registration date
- 17/10/2022
- Last edited
- 29/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims:
Music medicine may decrease anxiety and depression in cancer patients, but the mechanism by which this happens is not known. Therefore, the aim of this study is to determine the effects and underlying thematic perspectives of music medicine on anxiety and depression in cancer inpatients.
Who can participate:
Qualifying cancer inpatients aged 18 years and older at Cooper University Hospital
What does the study involve?
The participant will be asked to complete a short survey which should take about 10 minutes. The participant will also be asked to listen to live music in the comfort of their own room for about 15 minutes. The participant will then complete a second, short survey, which should take about 10 minutes.
What are the possible benefits and risks of participating?
Benefits of participating in this study include the entertainment value of experiencing live music in the comfort of ones’ hospital bed and a possible decrease in anxiety and depression. Additionally what is learned from the study may benefit cancer patients in the future. There are minimal risks associated with this survey and the study team does their best to minimize them. However, some of the questions may be about sensitive issues, which may be uncomfortable for some.
Where is the study run from?
Cooper University Hospital Cancer (USA)
When is the study starting and how long is it expected to run for?
June 2020 to July 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Michael Rosenheck, michaelrosenheck@gmail.com
Contact information
Principal investigator
2054 Bellefontaine St #A
Indianapolis, Indiana
46202
United States of America
 ORCID ID |
0000-0002-3332-3258 |
|---|---|
| Phone | +1 (0)9082394344 |
| michaelrosenheck@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-center prospective cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Quantitative and qualitative effects of live music medicine on anxiety and depression in cancer inpatients |
| Study objectives | Live music medicine decreases self-reported symptoms of anxiety and depression in cancer inpatients through a variety of previously postulated thematic prospective. |
| Ethics approval(s) | Approved 18/03/2021, Cooper University Hospital Institutional Review Board (1 Cooper Plaza, Camden, NJ 08103, USA; +1 (0)800 826 6737; IRBOnlineHelp@cooperhealth.edu), ref: IRB#21-014 |
| Health condition(s) or problem(s) studied | Anxiety and depression in cancer inpatients |
| Intervention | Twenty-four cancer inpatients participated in this prospective cohort study to measure the effects of a private, 15-minute, live guitar/singing performance on anxiety and depression. Questions modified from the Hospital Anxiety and Depression Scale (HADS) and a written free response section were used. The most frequently used words within the free response sections were made into a word cloud and evaluated based on their thematic perspective. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Anxiety and depression measured using a modified Hospital Anxiety and Depression Scale (HADS) questionnaire 1 hour before and immediately after the live musical performance |
| Key secondary outcome measure(s) |
1. Thematic perspectives analyzed through a word cloud of most used words by patients on the post-performance free-response question immediately after the live musical performance |
| Completion date | 29/07/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 26 |
| Total final enrolment | 24 |
| Key inclusion criteria | 1. Patients aged 18 years and older 2 .Cancer diagnosis 3. Roomed on the cancer inpatient floor of Cooper University Hospital |
| Key exclusion criteria | 1. Those who are deaf 2. Unable to read, write, or comprehend the survey 3. Had previously participated in the study 4. Under 18 years old 5. On end-of-life care or too critically ill to participate 6. Those that have more than one patient per room 7. The clinical team did not authorize the encounter |
| Date of first enrolment | 01/04/2021 |
| Date of final enrolment | 29/07/2021 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Camden, New Jersey
08103
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analyzed during the current study will be published as a supplement to the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Preprint results | 21/10/2022 | 29/12/2023 | No | No |
Editorial Notes
29/12/2023: Preprint reference added.
05/09/2022: Trial's existence confirmed by Cooper Health IRB.
