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

Does Interactive Group Drumming (IGD) Improve the Hospital Experience of Patients Undergoing Hematopoietic Stem Cell Transplant? - A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic Cell Transplant
• Intervention / Treatment: Behavioral: interactive group drumming sessions

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: interactive group drumming sessions; 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; interactive group drumming sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gather patient-reported data to suggest how participants respond to interactive group drumming (IGD)	Will be assessed by STADID Short Form Y-1. The after-IGD session measure will include a patient satisfaction item as well. The mean and standard deviation for each of these measures will be calculated.	Baseline up to 4 weeks after completion of IGD
Determine optimum length of session	Will be assessed by comparing actual length of session reported on facilitator post-session observation forms with participant satisfaction as reported in post-session. The mean and standard deviation for each of these measures will be calculated.	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	Targeted variables defined as anxiety, energy mood, distress, relaxation, pain, and patient satisfaction. Will compare for each participant. The mean and standard deviation for each of these measures will be calculated.	Baseline up to 4 weeks after completion of IGD
Effect of support care provider (SCP) presence for each participant and among participants	Will use a non-parametric test to compare difference in item scores with and without SCP presence.	Up to 4 weeks after completion of IGD
Change in physiological response to interactive group drumming (IGD)	Will be calculated at three time points during the session; repeated measures analysis of variance will be used to detect changes over the 3 readings.	Baseline up to 1 week after HCT
Gather patient-reported information to suggest the optimal number of interactive group drumming (IGD) sessions	Will be assessed by STADID Short Form Y-1. The after-IGD session measure will include a patient satisfaction item as well. The mean and standard deviation for each of these measures will be calculated	Baseline up to 4 weeks after completion of IGD

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Study Chair: Richard McQuellon, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2017
• Primary Completion (ACTUAL): September 25, 2019
• Study Completion (ACTUAL): December 4, 2019

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: November 13, 2017
• First Posted (ACTUAL): November 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRB00046180; CCCWFU 04417 (OTHER: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No