Massage Therapy Versus Music Therapy Pilot Study

ALL Clinical Trial

Official title:

Massage Therapy vs. Music Therapy vs. Usual Care in an Inpatient Setting: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227680
• Other study ID #: H-32796
• Status: Completed
• Phase: N/A
• First received: August 21, 2014
• Last updated: January 27, 2015
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• ALL

Intervention

Other:
• Music Therapy
Each music therapy session will begin with a brief description of the protocol, a musical introduction, a discussion of music preferences, and an informal assessment of participant needs to determine target goals, e.g., management of pain, anxiety, and other symptoms; breath control; emotional support and regulation. After the initial visit, the music therapist will create a playlist, based on participant preferences, and burn it onto a CD for the participant. The participant will be encouraged to use the book and listen to the CDs as often as he/she would like. After the initial visit, follow up visits will include techniques like music-facilitated breathing, music and imagery, music and relaxation/meditation, song writing, improvisation, singing, lyric substitution, lyric analysis, musical reminiscence, passive listening. There will be the opportunity to create music and write songs across multiple sessions, if these activities are indicated.
• Massage Therapy
Working with experts in hospital-based massage therapy, we have developed a semi-standardized inpatient massage protocol that utilizes Swedish techniques and acupressure. The protocol was adapted from our successful previous study of massage for perioperative care of patients undergoing implantation of permanent intravenous access devices. Massage therapists will focus on hands, feet, arms, and neck, as able, during the treatments.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Medical Center	Berklee College of Music, Muscular Therapy Institute Foundation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey questions	within 7 days after discharge	No
Secondary	Pain medication use	Administration of pain medication is documented in the electronic medical record each time a dose is given. We will use the EMR to document number of doses and amount (mg) of each dose during the participant's stay.	duration of hospital stay, an expected average of 4 days	No
Secondary	Sedative use	Administration of sedatives is documented in the electronic medical record each time a dose is given. We will use the EMR to document number of doses and amount (mg) of each dose during the participant's stay.	duration of hospital stay, an expected average of 4 days	No
Secondary	Length of stay		duration of hospital stay, an expected average of 4 days	No
Secondary	Number of re-admissions 30 days after initial discharge		30 days post-discharge	No
Secondary	Pain level	Pain levels are documented for every patient by nurses on a daily basis. We will utilize the electronic medical record (EMR) and document every pain evaluation (0-10 point scale of current pain intensity) performed by nurses on inpatient unit during participant's stay.	duration of hospital stay, an expected average of 4 days	No