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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

interventions and timing of interventions

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
148

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Alabama
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Arts Intervention
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.
Other: Arts Intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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