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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU 04417 | Other Identifier | Wake Forest University Health Sciences |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interactive group drumming sessions | Behavioral | interactive group drumming sessions |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard McQuellon, PhD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 17, 2019 | May 8, 2020 |
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interactive group drumming sessions
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| 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 |
| ICF_000.pdf |