NCT02227680

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

August 21, 2014

Last Update Submit

January 27, 2015

Conditions

Keywords

music therapymassage therapy

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey questions

    within 7 days after discharge

Secondary Outcomes (5)

  • Pain medication use

    duration of hospital stay, an expected average of 4 days

  • Sedative use

    duration of hospital stay, an expected average of 4 days

  • Length of stay

    duration of hospital stay, an expected average of 4 days

  • Number of re-admissions 30 days after initial discharge

    30 days post-discharge

  • Pain level

    duration of hospital stay, an expected average of 4 days

Study Arms (3)

Music Therapy

ACTIVE COMPARATOR

Patients randomized to the music therapy group will receive 1-3 10-40 minute music therapy sessions during each of the days of their stay on the inpatient unit. Each participant randomized to the music therapy intervention will be given a personalized CD and one portable CD player with headphones which they may keep after the study has ended.

Other: Music Therapy

Massage Therapy

ACTIVE COMPARATOR

Patients randomized to the massage therapy group will receive 1-3 10-40 minute massage treatments during each of the days of their stay on the inpatient unit.

Other: Massage Therapy

Usual Care

NO INTERVENTION

The control group will continue to receive usual care while on the Family Medicine Inpatient Unit.

Interventions

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.

Music 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.

Massage Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Interventions

Music TherapyMassage

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesTherapy, Soft TissueMusculoskeletal ManipulationsPhysical Therapy Modalities

Study Officials

  • Robert B Saper, MD, MPH

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 28, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations