Music Therapy and Hematopoietic Stem Cell Transplant

NCT03378089 | Completed

• 1 other identifier: CASE16Z17
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized, controlled study is to determine the effects of pre-transplant music therapy on mood, distress, and physical functioning variables in patients undergoing Hematopoietic Stem Cell Transplant (HSCT).

Conditions

Hematopoietic Stem Cell Transplant

Keywords

Music Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Distress Score

  Distress Thermometer assessments for both the experimental and standard care group will be given in the mid-late afternoon. This is an analog scale from 0-10 where 0 indicates no distress and 10 indicates extreme distress.

  From admission to day -1 (up to 9 days)

Secondary Outcomes (8)

• Change in Pain Score

  Within 24 hours of admission

• Change in Pain Score

  Up to 96 hours after session 1 (120 hours from admission)

• Change in Pain Score

  Up to 24 hours before procedure

• Change in Mood Score

  Within 24 hours of admission

• Change in Mood Score

  Up to 96 hours after session 1 (120 hours from admission)

Study Arms (2)

Music Therapy

EXPERIMENTAL

Participants in the experimental group will be given choices about how to proceed with the session: active or passive, improvisation, re-creative or receptive songs, or receptive (relaxation). Three music therapy sessions will be completed, the first within 24 hours of admission, the second 24-96 hours of session 1, and the final session the day before stem cell infusion.

Behavioral: Music Therapy

No Music Therapy

ACTIVE COMPARATOR

Participants randomized to the standard care group will be asked to rate the same symptoms as those in the experimental group. This will mark the beginning of a 45-minute control condition period during which the participants may fill the 45-minute time-period in whatever ways they choose.

Behavioral: No Music Therapy

Interventions

Music Therapy BEHAVIORAL

No narcotic or anti-emetic therapy will be administered for at least 2 hours prior to music therapy session. Music therapy sessions will be administered by a board certified music therapist (MT-BC) and last approximately 45 minutes. Involvement in sessions will be based on therapist and patient availability.

Music Therapy

No Music Therapy BEHAVIORAL

Participants will fill the same 45 minute period in any way they choose; however, they will be asked to refrain from listening to recorded music during this time.

No Music Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing inpatient allogeneic stem cell transplant
• Must be fluent in English
• Must be able to communicate verbally and have no significant hearing impairment
• Have capacity to provide consent
• All diagnosis, graft source, donor sources will be included.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Navneet Majhail, MD

  Cleveland Clinic, Taussig Cancer Institute, Case Comprehensive Cancer 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: December 15, 2017
• First Posted: December 19, 2017
• Study Start: February 26, 2018
• Primary Completion: June 21, 2019
• Study Completion: June 21, 2019
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

US (1)