Back to resultsA Pilot Study of Creative Arts Interventions for Neurology Inpatients
Primary Purpose
Epilepsy, Migraine
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Art Intervention
Sponsored by
About this trial
This is an interventional other trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Age > or = 18 years
- Diagnosis of refractory chronic epilepsy, status migrainosus, or chronic daily headache
- Elective admission to the Dartmouth-Hitchcock Medical Center Epilepsy monitoring unit or Headache service
- Capable of giving informed consent
Exclusion Criteria:
- Active psychiatric illness that prohibits safe visitation by artists
- Impairment of vision or hearing that would prohibit able to participate with participation in instructions necessary for the interventions.
- Active general medical condition that would impair consciousness.
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Artist Intervention
Arm Description
One of the three artists (visual artist, music therapist, creative writer) will work with subjects for up to 90 minutes.
Outcomes
Primary Outcome Measures
Feasibility of conducting a creative arts intervention study
The feasibility of the creative intervention will be determined by the completion rates of the initial intervention attempts. If less than 50% of patients complete the intervention it will be deemed unfeasible in the current format.
Secondary Outcome Measures
Change in patient anxiety before and after the intervention
Change in anxiety level will be calculated, based on patient questionnaire responses, following the creative intervention.
Change in patient distress before and after the intervention
Change in distress level will be calculated, based on patient questionnaire responses, following the creative intervention.
Change in patient depression before and after the intervention
Change in depression level will be calculated, based on patient questionnaire responses, following the creative intervention.
Change in frequency of as-needed pain medication use
As-needed pain medication utilization will be evaluated following the creative arts intervention through subject discharge.
Length of hospital stay
Length of hospital stay will be calculated.
Full Information
NCT ID
NCT03520777
First Posted
April 13, 2018
Last Updated
July 16, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03520777
Brief Title
A Pilot Study of Creative Arts Interventions for Neurology Inpatients
Official Title
A Pilot Study of Creative Arts Interventions for Neurology Inpatients in the Epilepsy Monitoring Unit and the Headache Service
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to assess the feasibility of a Creative Artists Program intervention with epilepsy and headache patients admitted to Dartmouth-Hitchcock Medical Center for care by the Department of Neurology.
Detailed Description
Qualifying patients admitted to Epilepsy monitoring or Headache treatment will be approached for participation in the study. Patients who consent to the study will be given a chance to work with one of three creative artists (visual artist, creative writer, therapeutic musician). The artist will be selected according to a pre-determined schedule, and the arts intervention may last up to 90 minutes. Subjects will be asked to complete study questionnaires before and after the arts intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Migraine
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Artist Intervention
Arm Type
Other
Arm Description
One of the three artists (visual artist, music therapist, creative writer) will work with subjects for up to 90 minutes.
Intervention Type
Other
Intervention Name(s)
Art Intervention
Intervention Description
Type of artist intervention will be determined by the subject and the assigned artist.
Primary Outcome Measure Information:
Title
Feasibility of conducting a creative arts intervention study
Description
The feasibility of the creative intervention will be determined by the completion rates of the initial intervention attempts. If less than 50% of patients complete the intervention it will be deemed unfeasible in the current format.
Time Frame
Through study completion, approximately 1 year
Secondary Outcome Measure Information:
Title
Change in patient anxiety before and after the intervention
Description
Change in anxiety level will be calculated, based on patient questionnaire responses, following the creative intervention.
Time Frame
Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).
Title
Change in patient distress before and after the intervention
Description
Change in distress level will be calculated, based on patient questionnaire responses, following the creative intervention.
Time Frame
Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).
Title
Change in patient depression before and after the intervention
Description
Change in depression level will be calculated, based on patient questionnaire responses, following the creative intervention.
Time Frame
Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).
Title
Change in frequency of as-needed pain medication use
Description
As-needed pain medication utilization will be evaluated following the creative arts intervention through subject discharge.
Time Frame
Each patient as-needed medication use will be assessed after the arts intervention and until discharge from the hospital (approximately Day 3 - 21).
Title
Length of hospital stay
Description
Length of hospital stay will be calculated.
Time Frame
Each patient's admission duration (approximately 3 - 21 Days).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > or = 18 years
Diagnosis of refractory chronic epilepsy, status migrainosus, or chronic daily headache
Elective admission to the Dartmouth-Hitchcock Medical Center Epilepsy monitoring unit or Headache service
Capable of giving informed consent
Exclusion Criteria:
Active psychiatric illness that prohibits safe visitation by artists
Impairment of vision or hearing that would prohibit able to participate with participation in instructions necessary for the interventions.
Active general medical condition that would impair consciousness.
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Creative Arts Interventions for Neurology Inpatients
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