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

Hematopoietic Cell Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345433
• Other study ID #: IRB00046180
• Secondary ID: CCCWFU 04417
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: December 4, 2019

Study information

• Verified date: December 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 4, 2019
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematopoietic Cell Transplant

Intervention

Behavioral:
• interactive group drumming sessions
interactive group drumming sessions

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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