Clinical trial NCT03217682: Impact of Massage Therapy and Music Therapy on the Quality of Life of Hospice Patients
Official title: Impact of Massage Therapy and Music Therapy on the Quality of Life of Hospice Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Depression
Quality of Life
Keywords: Hospice
Palliative Care
Integrative Medicine
Massage Therapy
Music Therapy
Caregivers
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: After the patient has been registered into the study, they will be assigned to either the music therapy or massage therapy cohort. The music therapy cohort will be available to the first 30 patients and 30 caregivers accrued. Upon reaching 60 subjects enrolled, the music therapy cohort will close to accrual and the massage therapy cohort will open to accrual. Once the massage therapy cohort has enrolled 30 patients and 30 caregivers, the massage therapy cohort will close to accrual and the study will be closed to all further accrual.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a cohort study where subjects will receive either massage therapy or music therapy interventions to evaluate their impact on hospice patients.

Detailed description: There is growing evidence that integrative therapies such as massage therapy and music therapy can be effective therapeutic tools for relief of pain and non-pain symptoms in hospice and palliative care patients. Massage and music therapies can provide comfort, relaxation, and improve quality of life for patients. The investigator's primary aim is to compare the effects of massage and music therapies on the quality of life of hospice patients. The overall goal is to further improve pain, depression, anxiety, and poor well-being or quality of life in hospice patients through the use of integrative therapies, specifically massage and music therapies, as add-on to standard hospice clinical care. Patients will be assigned to either the massage therapy or music therapy cohort. Questionnaires will be utilized before and after each massage or music therapy intervention to quantify symptom and quality of life levels.

Eligibility criteria: Inclusion Criteria:

* Patient is currently enrolled in Mayo Clinic Hospice
* Age 18 years or older
* ESAS-r scores of 5 or greater on pain, depression, anxiety, or best well-being (clinical assessment by hospice nursing staff)
* Patient or caregiver must be able to participate in brief interviews and complete questionnaires (verbally or physically)

Exclusion Criteria:

* Patients that would not be able to get a massage due to complexity of medical care including complex wound and multiple drains

Primary outcomes:
measure: Change in Edmonton Symptom Assessment System - Revised
timeFrame: Baseline to 3 weeks
Secondary outcomes:
measure: Change in Edmonton Symptom Assessment System - Revised (Other symptoms)
timeFrame: Baseline to 3 weeks
measure: Change in Linear Analogue Self Assessment (LASA)
timeFrame: Baseline to 3 weeks
measure: Change in Patient Health Questionnaire for Depression and Anxiety (PHQ-4)
timeFrame: Baseline to 3 weeks
measure: Change in Pearlin role overload measure (ROM)
timeFrame: Baseline to 3 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Maria Lapid, MD
role: PRINCIPAL_INVESTIGATOR
References: