Impact of Massage Therapy and Music Therapy on the Quality of Life of Hospice Patients

Depression Clinical Trial

Official title:

Impact of Massage Therapy and Music Therapy on the Quality of Life of Hospice Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03217682
• Other study ID #: 17-002950
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: March 11, 2022

Study information

• Verified date: May 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 11, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Pain
• Quality of Life

Intervention

Other:
• Music Therapy
Music therapy sessions
• Massage Therapy
Massage therapy sessions

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Edmonton Symptom Assessment System - Revised	The primary endpoints are patient pain, depression, anxiety and wellbeing as measured by ESAS-r. Pro-rated area under the curve (AUC) statistics will be calculated for all individual items and total scores. The pro-rated AUC for ESAS-r measured pain, depression, anxiety, and wellbeing will all be utilized individually to assess the primary endpoint. The pro-rated AUC will be compared to the assessment score prior to any massage or music therapy. If there is any improvement, the therapy will be considered a success since any improvement will be seen as beneficial.	Baseline to 3 weeks
Secondary	Change in Edmonton Symptom Assessment System - Revised (Other symptoms)	Secondary endpoints include all other symptoms (tiredness, drowsiness, nausea, lack of appetite, shortness of breath) as measured by the ESAS-r. Similar analysis will be conducted for all other endpoints as was conducted for the primary outcome. Pro-rated area under the curve (AUC) statistics will be calculated for all individual items and total scores.	Baseline to 3 weeks
Secondary	Change in Linear Analogue Self Assessment (LASA)	Secondary endpoints include symptoms as measured by the LASA (overall quality of life [QOL], mental well-being, physical well-being, emotional well-being, social activity, spiritual well-being, pain frequency, pain severity, fatigue, and social support). LASA items are stand alone, thus no scoring is necessary, but individual LASA items may be transposed so lower scores mean worse symptoms and higher scores mean less symptoms. This will allow consistency and thus easier data interpretation. Pro-rated area under the curve (AUC) statistics will be calculated for all individual items and total scores. Similar analysis will be conducted for all other endpoints as was conducted for the primary outcome.	Baseline to 3 weeks
Secondary	Change in Patient Health Questionnaire for Depression and Anxiety (PHQ-4)	Secondary endpoints include depression and anxiety symptoms as measured by the PHQ-4. Similar analysis will be conducted for all other endpoints as was conducted for the primary outcome.	Baseline to 3 weeks
Secondary	Change in Pearlin role overload measure (ROM)	Secondary endpoints include caregiver stress as measured by the ROM. Pro-rated area under the curve (AUC) statistics will be calculated for all individual items and total scores. Similar analysis will be conducted for all other endpoints as was conducted for the primary outcome.	Baseline to 3 weeks

External Links

•   Mayo Clinic Clinical Trials