- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04024670
The Impact of Arts-Based Interventions on Patient Hospital Experience
July 9, 2024 updated by: Kimberly Kirklin, University of Alabama at Birmingham
The Impact of Arts-Based Interventions on Patient Hospital Experience for Patients on a High-Risk Obstetrics and Bone Transplant Units
nuts and bolts
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
interventions and timing of interventions
Study Type
Interventional
Enrollment (Actual)
148
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion:
- Inpatient on either Bone Marrow Transplant ICU or High Risk Obstetrics Unit
- Estimated length of stay 2 or more weeks
- Age >18
- Patients who will potentially benefit from the AIM experience
Additional Inclusion Criteria:
- For the High Risk Obstetrics Unit group (hand-sewing), patients should be physically able to participate in hand-sewing activity.
- For the Bone Marrow Transplant IUC group (story-telling/poetry), patients should be physically able to participate in story-telling/poetry activity.
Exclusion:
- Patient too ill
- Complex medical condition that requires therapies which would not allow time for participation
- Declined to participate
- Age <18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Patients on a high-risk obstetrics unit with an anticipated stay of two or more weeks
patients in this group will receive twice weekly sewing and embroidery interactions with a professional artist in residence.
|
If selected for the arts activity, an artist in residence will visit you 3 times a week for a total of 3 weeks during your hospital stay.
Two visits will focus on the arts activity and one visit will be the administration of the questionnaire.
Each visit will be approximately 25 minutes at a time.
|
|
Active Comparator: Patients on a bone marrow transplant unit with an anticipated stay of two or more weeks
patients in this group will receive twice weekly visits with a professional storyteller.
|
If selected for the arts activity, an artist in residence will visit you 3 times a week for a total of 3 weeks during your hospital stay.
Two visits will focus on the arts activity and one visit will be the administration of the questionnaire.
Each visit will be approximately 25 minutes at a time.
|
|
No Intervention: HRO Standard of Care
SOC
|
|
|
No Intervention: BMT Standard of Care
SOC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate patient experience during the course of intervention using name of survey
Time Frame: Baseline at admissions
|
define survey - evaluate experiences, range of survey - explain likert scale 0-10 with 0 being x (allows patient to rate how much they disagree or agree with a statement), 0 being the worst outcome and 10 being the best
|
Baseline at admissions
|
|
Evaluate patient experience during the course of intervention using name of survey
Time Frame: Baseline - end of week 1
|
define survey - evaluate experiences, range of survey - explain likert scale 0-10 with 0 being x (allows patient to rate how much they disagree or agree with a statement), 0 being the worst outcome and 10 being the best
|
Baseline - end of week 1
|
|
Evaluate patient experience during the course of intervention using name of survey
Time Frame: week 1- week 2
|
define survey - evaluate experiences, range of survey - explain likert scale 0-10 with 0 being x (allows patient to rate how much they disagree or agree with a statement), 0 being the worst outcome and 10 being the best
|
week 1- week 2
|
|
Evaluate patient experience during the course of intervention using name of survey
Time Frame: week 2 - week 3
|
define survey - evaluate experiences, range of survey - explain likert scale 0-10 with 0 being x (allows patient to rate how much they disagree or agree with a statement), 0 being the worst outcome and 10 being the best
|
week 2 - week 3
|
|
Evaluate patient experience during the course of intervention using name of survey
Time Frame: week 3 - weekly up to 10 weeks
|
define survey - evaluate experiences, range of survey - explain likert scale 0-10 with 0 being x (allows patient to rate how much they disagree or agree with a statement), 0 being the worst outcome and 10 being the best
|
week 3 - weekly up to 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kimberly P Kirklin, MA, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
April 25, 2019
First Submitted That Met QC Criteria
July 17, 2019
First Posted (Actual)
July 18, 2019
Study Record Updates
Last Update Posted (Actual)
July 10, 2024
Last Update Submitted That Met QC Criteria
July 9, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-300001347
- UL 1 TR003096 (Other Grant/Funding Number: Foundation for Orthopaedic Trauma)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
At this time we do not have IRB approval to share IPD.
We may change this in the future.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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