Clinical trial NCT02227680: Massage Therapy Versus Music Therapy Pilot Study
Official title: Massage Therapy vs. Music Therapy vs. Usual Care in an Inpatient Setting: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ALL
Keywords: music therapy
massage therapy
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Muscular Therapy Institute Foundation, Inc.
name: Berklee College of Music
First posted: 2014-08-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project studies the feasibility of (1) implementing massage therapy and music therapy onto a busy medical inpatient unit at Boston Medical Center, and (2) evaluating massage therapy and music therapy's impact on patient satisfaction, patient outcomes, and cost. The investigators will conduct a randomized controlled trial comparing massage therapy, music therapy, and usual care to collect preliminary data on critical outcomes for patients (satisfaction, symptom control) and for the hospital (pain medication use and length of stay, both critical drivers of cost). The investigators anticipate using these preliminary data to apply for a future larger and longer adequately powered randomized controlled trial to definitively answer the following research questions: does implementation of an inpatient massage therapy and/or music therapy service (a) improve patient satisfaction; (b) reduce symptoms such as pain; and (c) lower health care costs through less pain medication and reduced length of stay?

Detailed description: This randomized controlled trial compares massage therapy to usual care and music therapy to usual care for patients admitted to the Family Medicine Inpatient Unit of Boston Medical Center. Ninety family medicine inpatients will be recruited by the research assistant to participate in the study. Participants will be randomized directly following consent in a 1:1:1 ratio to massage therapy, music therapy, or usual care. Individuals assigned to the usual care group will receive the choice of a massage voucher for one massage at Boston Medical Center's Integrative Medicine program or a music therapy CD following completion of the study.

Treatment assignments will be prepared by the study biostatistician, using a permuted block method with varying block sizes of 3, 6, and 9, prior to the start of the study. These will be sealed in sequentially numbered opaque envelopes. This order will not be changed. A research assistant will take a randomization envelope, in sequential order, and read the treatment assignment to the participant following enrollment.

After enrollment and randomization is complete each day, the massage therapist and music therapist will begin to see participants for treatment. Treatments will take place in the inpatient hospital room. Curtains will be pulled closed to maintain privacy in rooms that have two beds. Both music and massage therapists will be present Monday-Sunday to provide treatment to participants.

Treatments will be attempted 1-3 times per day for the duration of the participant's stay on the unit, based on the participant's availability (they may be scheduled for diagnostic tests, imaging, consults, etc). The music and massage therapists will work down the list of participants, visiting each one by one and administering treatment (details below for each therapy). If a participant is not available at the time the therapist comes by, he/she will revisit the participant after they have gone through their list and administered treatments. Once the therapist has provided the therapy once to every patient on his/her list, he/she will begin at the top of the list and provide a second round of treatments, and repeat again for a third round as time permits.

The music therapist and massage therapist will create a note sheet each day for each participant. This will allow them to track number of treatments as well as any comments relevant to treatment (patient preferences, etc). A research assistant will collect these at the end of each day, enter them into the secure online database, and store them in a locked file cabinet.

The music therapist and massage therapist will each be given an updated list of patients to treat (first name, last initial, room number) each morning. These lists (separated by treatment group) will include the newly enrolled and randomized participants as well as those who have not yet been discharged. At the end of each day, the therapists will report to the research assistant on how many sessions were provided to each participant.

When the research assistant notes that a participant has been discharged, he/she has approximately 7 days to contact the patient (by phone or email) to administer the endline survey. Then, thirty days after discharge, the research assistant will check the participant's electronic medical record to see if he/she has been admitted again since discharge. Participants in the control group, following discharge and completion of the endline survey, will be mailed either a music/meditation CD or a voucher for massage at BMC, according to their preference.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Inpatient on the Boston Medical C enter Family Medicine inpatient service

Exclusion Criteria:

* Inability to provide informed consent
* Contagious skin disease or infection
* Hemophilia
* Thrombocytopenia
* Encephalopathy
* Dementia
* Altered mental status
* 1:1 status (requiring constant supervision)
* Any condition, as determined by the attending physician, which would prevent participation in the study.
* Observation status

Primary outcomes:
measure: Patient satisfaction
timeFrame: within 7 days after discharge
Secondary outcomes:
measure: Pain medication use
timeFrame: duration of hospital stay, an expected average of 4 days
measure: Sedative use
timeFrame: duration of hospital stay, an expected average of 4 days
measure: Length of stay
timeFrame: duration of hospital stay, an expected average of 4 days
measure: Number of re-admissions 30 days after initial discharge
timeFrame: 30 days post-discharge
measure: Pain level
timeFrame: duration of hospital stay, an expected average of 4 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Robert B Saper, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: