High Risk PregnancyNCT04024670
The Impact of Arts-Based Interventions on Patient Hospital Experience
A study testing Arts Intervention in people with High Risk Pregnancy and Bone Marrow, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
nuts and bolts Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Risk Pregnancy, Bone Marrow
- What is being tested?
- Arts Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient too ill
- Complex medical condition that requires therapies which would not allow time for participation
- Declined to participate
- Age <18
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: The Impact of Arts-Based Interventions on Patient Hospital Experience for Patients on a High-Risk Obstetrics and Bone Transplant Units
nuts and bolts
Read the detailed description
interventions and timing of interventions
- Conditions
- High Risk Pregnancy, Bone Marrow
- Being tested
- Arts Intervention
- Keywords
- arts in medicine, sewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arts InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients on a high-risk obstetrics unit with an anticipated stay of two or more weeks | Active comparator | patients in this group will receive twice weekly sewing and embroidery interactions with a professional artist in residence. Receives: Other: Arts Intervention |
| Patients on a bone marrow transplant unit with an anticipated stay of two or more weeks | Active comparator | patients in this group will receive twice weekly visits with a professional storyteller. Receives: Other: Arts Intervention |
| HRO Standard of Care | No intervention | SOC |
| BMT Standard of Care | No intervention | SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate patient experience during the course of intervention using name of survey
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
Measured: Baseline at admissions
Evaluate patient experience during the course of intervention using name of survey
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
Measured: Baseline - end of week 1
Evaluate patient experience during the course of intervention using name of survey
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
Measured: week 1- week 2
Evaluate patient experience during the course of intervention using name of survey
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
Measured: week 2 - week 3
Evaluate patient experience during the course of intervention using name of survey
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
Measured: week 3 - weekly up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Jan 2019
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk PregnancyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Kirklin, University of Alabama at Birmingham
- Investigators
- Kimberly P Kirklin, MA, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024670
- Sponsor's protocol ID
- IRB-300001347
- Other IDs
- UL 1 TR003096
- Status last verified
- Jul 2024
- First submitted
- 25 Apr 2019
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time we do not have IRB approval to share IPD. We may change this in the future.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Arts-Based Interventions on Patient Hospital Experience for Patients on a High-Risk Obstetrics and Bone Transplant Units
- ClinicalTrials.gov ID
- NCT04024670
- Acronym / sponsor ID
- IRB-300001347
- Conditions
- High Risk Pregnancy, Bone Marrow
- Keywords
- arts in medicine, sewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
nuts and bolts
Detailed description
interventions and timing of interventions
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients on a high-risk obstetrics unit with an anticipated stay of two or more weeks | Active comparator | Other: Arts Interventionpatients in this group will receive twice weekly sewing and embroidery interactions with a professional artist in residence. |
| Patients on a bone marrow transplant unit with an anticipated stay of two or more weeks | Active comparator | Other: Arts Interventionpatients in this group will receive twice weekly visits with a professional storyteller. |
| HRO Standard of Care | No intervention | –SOC |
| BMT Standard of Care | No intervention | –SOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- For the High Risk Obstetrics Unit group (hand-sewing), patients should be physically able to participate in hand-sewing activity.
Key exclusion criteria (4 listed)
- Patient too ill
- Complex medical condition that requires therapies which would not allow time for participation
- Declined to participate
- Age <18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arts InterventionIf 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. | Other | Patients on a bone marrow transplant unit with an anticipated stay of two or more weeks, Patients on a high-risk obstetrics unit with an anticipated stay of two or more weeks |
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No. At this time we do not have IRB approval to share IPD. We may change this in the future.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly P Kirklin, MA principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arts Intervention in people with High Risk Pregnancy and Bone Marrow, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate patient experience during the course of intervention using name of survey (time frame: Baseline at admissions). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.