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CompletedNCT03345433Updated May 14, 2020

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

An interventional study of interactive group drumming sessions in Hematopoietic Cell Transplant, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-14.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hematopoietic Cell Transplant
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • 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

Interventions

  • Behavioralinteractive group drumming sessions

    interactive group drumming sessions

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 1 week after hematopoietic cell transplant (HCT)

  2. 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.

    Time frame: Up to 1 week after HCT

Secondary outcomes

  1. 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.

    Time frame: Baseline up to 4 weeks after completion of IGD

  2. 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.

    Time frame: Up to 4 weeks after completion of IGD

  3. 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.

    Time frame: Baseline up to 4 weeks after completion of IGD

  4. 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.

    Time frame: Up to 4 weeks after completion of IGD

  5. 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.

    Time frame: Baseline up to 1 week after HCT

  6. 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

    Time frame: Baseline up to 4 weeks after completion of IGD

06

Study locations

1 site
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
07

References and documents

Study documents

  • Informed consent form · Jun 17, 2019

Documents are hosted by the registry — open the source record to download them.

08

Registry details

Key details

Study ID
NCT03345433
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Nov 17, 2017
Start date
Nov 15, 2017
Primary completion
Sep 25, 2019
Completion
Dec 4, 2019
Last update
May 14, 2020

Study contacts

Richard McQuellon, PhD
study chair · Wake Forest University Health Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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