Skip to main content
OpenTrials
Completed

NCT Number: NCT03345433

Interactive Group Drumming (IGD) in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hematopoietic Cell Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

interactive group drumming sessions

Behavioral

interactive group drumming sessions

Primary outcomes

  1. Rate of participation

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

    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.

  2. Rate of completion

    Time frame: Up to 1 week after HCT

    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.

Secondary outcomes

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

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

  2. Determine optimum length of session

    Time frame: Up to 4 weeks after completion of IGD

    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.

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

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

    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.

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

    Time frame: Up to 4 weeks after completion of IGD

    Will use a non-parametric test to compare difference in item scores with and without SCP presence.

  5. Change in physiological response to interactive group drumming (IGD)

    Time frame: Baseline up to 1 week after HCT

    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.

  6. Gather patient-reported information to suggest the optimal number of interactive group drumming (IGD) sessions

    Time frame: Baseline up to 4 weeks after completion of 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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2017
Registry last updated
May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.