Interactive Group Drumming (IGD) in Hospital Experience of Patients Undergoing Hematopoietic Stem Cell Transplant - A Pilot Study

NCT03345433 | Completed

• 2 other identifiers: IRB00046180CCCWFU 04417
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to determine if it is possible to perform group drumming as an intervention during HCT, to begin to understand how interactive group drumming during HCT treatment affects patients' well-being (good and bad) during the treatment course and in the first four weeks after completion of the drumming sessions.

Conditions

Hematopoietic Cell Transplant

Outcome Measures

Primary Outcomes (2)

• Rate of participation

  Defined as the number of subjects willing to participate in the interactive group drumming (IGD) divided by the number approached and asked to participate. These rates will be reported, along with the corresponding 95% confidence interval.

  Up to 1 week after hematopoietic cell transplant (HCT)

• Rate of completion

  Defined as the ratio of (the number of individuals who successfully complete the study \[4 sessions of IGD (about 20 minutes \[min.\] each)\], with two pre-and post- surveys \[8 minutes total, and two questionnaires (10 minutes total) about 160 minutes total time\]) relative to the number of individuals who consent to the study (the number from the numerator of the first ratio \[participation\]). These rates will be reported, along with the corresponding 95% confidence interval.

  Up to 1 week after HCT

Secondary Outcomes (6)

• Gather patient-reported data to suggest how participants respond to interactive group drumming (IGD)

  Baseline up to 4 weeks after completion of IGD

• Determine optimum length of session

  Up to 4 weeks after completion of IGD

• Gather patient-reported information to study whether the effect of interactive group drumming (IGD) on targeted variables is more pronounced in successive sessions

  Baseline up to 4 weeks after completion of IGD

• Effect of support care provider (SCP) presence for each participant and among participants

  Up to 4 weeks after completion of IGD

• Change in physiological response to interactive group drumming (IGD)

  Baseline up to 1 week after HCT

Study Arms (1)

interactive group drumming sessions

EXPERIMENTAL

Participants will be involved in four interactive group drumming sessions (10-30 minutes each) and complete surveys and questionnaires about music and quality of life.

Behavioral: interactive group drumming sessions

Interventions

interactive group drumming sessions BEHAVIORAL

interactive group drumming sessions

interactive group drumming sessions

Eligibility Criteria

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

You may qualify if:

• People who are at least 18 years old and are scheduled for HCT
• Individuals must be able to understand and willing to sign a written informed consent form

You may not qualify if:

• People who are too ill to participate, i.e., while they are in contact isolation or have low platelets (less than 20,000/mcl) will not participate until their condition has improved.
• Patients receiving outpatient HCT except patients with multiple myeloma. Patients with multiple myeloma may participate in the study even though they tend to spend nights away from the hospital.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Study Officials

• Richard McQuellon, PhD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: interactive group drumming sessions

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 17, 2017
• Study Start: November 15, 2017
• Primary Completion: September 25, 2019
• Study Completion: December 4, 2019
• Last Updated: May 14, 2020

Record last verified: 2019-12

Locations

US (1)