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Clinical Trials/NCT02880202
NCT02880202
Completed
Not Applicable

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

Mayo Clinic1 site in 1 country53 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Mayo Clinic
Enrollment
53
Locations
1
Primary Endpoint
Change in Edmonton Symptom Assessment System - Revised
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This is a pilot study to evaluate the impact of massage therapy in hospice patients.

Detailed Description

As an integrative therapy, there is growing evidence that massage therapy can be an effective therapeutic tool for relief of pain and non-pain symptoms in hospice and palliative care patients. Massage therapy can provide comfort, relaxation, and improve quality of life for patients. The primary aim of the study is to gather data on the effects of complementary massage therapy on patient's symptoms and quality of life. The study goal is to improve patient symptoms of pain, anxiety, depression, and quality of life through the use of massage therapy provided to hospice patients. Questionnaires would be utilized before and after each massage intervention and would quantify symptom and quality of life levels.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
December 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria I. Lapid, M.D.

PI

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older
  • Clinically determined by hospice staff to be appropriate for massage therapy (ESAS-r scores of 5 or greater on pain, depression, anxiety, or best well-being)
  • Place of residence within 30 minutes of downtown Rochester
  • Patient or caregiver must be able to participate in brief interviews and complete questionnaires (verbally or physically)

Exclusion Criteria

  • Patients ineligible for massage therapy due to complexity of medical care including complex wound and multiple drains

Outcomes

Primary Outcomes

Change in Edmonton Symptom Assessment System - Revised

Time Frame: Baseline to 3 weeks

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 therapy. If there is any improvement, the massage therapy will be considered a success since any improvement will be seen as beneficial.

Secondary Outcomes

  • Change in Edmonton Symptom Assessment System - Revised (Other symptoms)(Baseline to 3 weeks)
  • Change in Linear Analogue Self Assessment (LASA)(Baseline to 3 weeks)
  • Change in Patient Health Questionnaire for Depression and Anxiety (PHQ-4)(Baseline to 3 weeks)
  • Change in Pearlin role overload measure (ROM)(Baseline to 3 weeks)

Study Sites (1)

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