Quality of LifeNCT03322228
Music Therapy Intervention to Reduce Caregiver Distress at the End of Life
A study testing Music Therapy in people with Quality of Life and Stress, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a study to assess the feasibility and acceptability of implementing a music therapy intervention for caregivers of hospitalized patients who are referred to inpatient hospice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Stress, Anxiety
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2017to 31 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Self-identified caregiver
- English-speaking
Who cannot join
- 1. Unable to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music Therapy Intervention to Reduce Caregiver Distress at the End of Life: A Feasibility Study
This is a study to assess the feasibility and acceptability of implementing a music therapy intervention for caregivers of hospitalized patients who are referred to inpatient hospice.
Read the detailed description
Caregivers are at high risk for stress, poor quality of life (QOL), and burnout. As a patient nears death, common themes for caregivers include anxiety and emotional distress from impending death, anticipatory grief, and acceptance of loss, which negatively impact the caregiver QOL. Investigators propose to conduct a pilot project to investigate music therapy impact on caregiver distress for caregivers of imminently dying hospitalized patients referred to hospice. Upon enrollment, caregivers will be provided a music therapy intervention with legacy-building components, and will be asked to complete 3 brief questionnaires on distress and quality of life before and after the music therapy to assess their response to the intervention. The overall aim is to reduce caregiver distress and optimize QOL.
- Conditions
- Quality of Life, Stress, Anxiety, Depression
- Being tested
- Music Therapy
- Keywords
- Hospice, Palliative Care, Integrative Medicine, Music Therapy, Inpatient, Caregiver
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
Music therapy is tailored to subject preference. Examples are active music-making, supportive listening, and includes opportunities for legacy building to decrease caregiver distress and promote self-care.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | 1 music therapy session, lasting approximately 45 min-1 hr Receives: Other: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pearlin role overload measure (ROM)
4-item self-administered measure of caregiver stress
Measured: Baseline to 6 months
Secondary outcomes (3)
Linear Analogue Self-Assessment (LASA)
10-item self-report of general measures of quality of life (QOL)
Measured: Baseline to 6 months
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
4-item self-administered screening tool that combined two validated two-item screeners for depression and anxiety
Measured: Baseline to 6 months
Music Therapy Program Survey
Survey to assess satisfaction regarding the therapy service provided
Measured: Up to 72 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start5 Oct 2017
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study plans to enroll 20 subjects. All subjects will receive 1 music therapy intervention lasting approximately 1 hour.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria I. Lapid, M.D., Mayo Clinic
- Investigators
- Maria Lapid, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322228
- Sponsor's protocol ID
- 17-005811
- Status last verified
- Nov 2020
- First submitted
- 13 Oct 2017
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whitford KJ, Ulrich AM, Larsen BE, Phelps CM, Siska MJ, Bigelow ML, Dockter TJ, Wood C, Walton MP, Stelpflug AJ, Lapid MI. Music Therapy Intervention to Reduce Caregiver Distress at End of Life: A Feasibility Study. J Pain Symptom Manage. 2023 May;65(5):e417-e423. doi: 10.1016/j.jpainsymman.2023.01.009. Epub 2023 Jan 19.
PubMed 36682675
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy Intervention to Reduce Caregiver Distress at the End of Life: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03322228
- Acronym / sponsor ID
- 17-005811
- Conditions
- Quality of Life, Stress, Anxiety, Depression
- Keywords
- Hospice, Palliative Care, Integrative Medicine, Music Therapy, Inpatient, Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 26 Oct 2017 (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.
This is a study to assess the feasibility and acceptability of implementing a music therapy intervention for caregivers of hospitalized patients who are referred to inpatient hospice.
Detailed description
Caregivers are at high risk for stress, poor quality of life (QOL), and burnout. As a patient nears death, common themes for caregivers include anxiety and emotional distress from impending death, anticipatory grief, and acceptance of loss, which negatively impact the caregiver QOL. Investigators propose to conduct a pilot project to investigate music therapy impact on caregiver distress for caregivers of imminently dying hospitalized patients referred to hospice. Upon enrollment, caregivers will be provided a music therapy intervention with legacy-building components, and will be asked to complete 3 brief questionnaires on distress and quality of life before and after the music therapy to assess their response to the intervention. The overall aim is to reduce caregiver distress and optimize QOL.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study plans to enroll 20 subjects. All subjects will receive 1 music therapy intervention lasting approximately 1 hour.
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Other: Music Therapy1 music therapy session, lasting approximately 45 min-1 hr |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Self-identified caregiver
- English-speaking
Key exclusion criteria (1 listed)
- 1. Unable to provide consent
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 |
|---|---|---|
| Music TherapyMusic therapy is tailored to subject preference. Examples are active music-making, supportive listening, and includes opportunities for legacy building to decrease caregiver distress and promote self-care. | Other | Music Therapy |
Primary outcome
Pearlin role overload measure (ROM)
Time frame: Baseline to 6 months
4-item self-administered measure of caregiver stress
3 secondary outcomes
Linear Analogue Self-Assessment (LASA)
Time frame: Baseline to 6 months
Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
Time frame: Baseline to 6 months
Music Therapy Program Survey
Time frame: Up to 72 hours after intervention
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 24 Nov 2020.
- Derived from this study: PubMed 36682675Whitford KJ, Ulrich AM, Larsen BE, Phelps CM, Siska MJ, Bigelow ML, Dockter TJ, Wood C, Walton MP, Stelpflug AJ, Lapid MI. Music Therapy Intervention to Reduce Caregiver Distress at End of Life: A Feasibility Study. J Pain Symptom Manage. 2023 May;65(5):e417-e423. doi: 10.1016/j.jpainsymman.2023.01.009. Epub 2023 Jan 19.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Maria Lapid, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Quality of Life and Stress, run by Mayo Clinic 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 24 Nov 2020. 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?
Pearlin role overload measure (ROM) (time frame: Baseline to 6 months). 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 NCT03322228, which also lists 1 linked publication.
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 24 Nov 2020.