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A Pilot Study of Creative Arts Interventions for Neurology Inpatients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03520777
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Lara K. Ronan, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Epilepsy Migraine Other: Art Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study of Creative Arts Interventions for Neurology Inpatients in the Epilepsy Monitoring Unit and the Headache Service
Actual Study Start Date : September 19, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Artist Intervention
One of the three artists (visual artist, music therapist, creative writer) will work with subjects for up to 90 minutes.
Other: Art Intervention
Type of artist intervention will be determined by the subject and the assigned artist.




Primary Outcome Measures :
  1. Feasibility of conducting a creative arts intervention study [ Time Frame: Through study completion, approximately 1 year ]
    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 :
  1. Change in patient anxiety before and after the intervention [ Time Frame: Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21). ]
    Change in anxiety level will be calculated, based on patient questionnaire responses, following the creative intervention.

  2. Change in patient distress before and after the intervention [ Time Frame: Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21). ]
    Change in distress level will be calculated, based on patient questionnaire responses, following the creative intervention.

  3. Change in patient depression before and after the intervention [ Time Frame: Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21). ]
    Change in depression level will be calculated, based on patient questionnaire responses, following the creative intervention.

  4. Change in frequency of as-needed pain medication use [ 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). ]
    As-needed pain medication utilization will be evaluated following the creative arts intervention through subject discharge.

  5. Length of hospital stay [ Time Frame: Each patient's admission duration (approximately 3 - 21 Days). ]
    Length of hospital stay will be calculated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > or = 18 years
  2. Diagnosis of refractory chronic epilepsy, status migrainosus, or chronic daily headache
  3. Elective admission to the Dartmouth-Hitchcock Medical Center Epilepsy monitoring unit or Headache service
  4. Capable of giving informed consent

Exclusion Criteria:

  1. Active psychiatric illness that prohibits safe visitation by artists
  2. Impairment of vision or hearing that would prohibit able to participate with participation in instructions necessary for the interventions.
  3. Active general medical condition that would impair consciousness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520777


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center

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Responsible Party: Lara K. Ronan, Principal Investigator, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03520777    
Other Study ID Numbers: 30498
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases