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Completed

NCT Number: NCT03520777

A Pilot Study of Creative Arts Interventions for Neurology Inpatients

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Art Intervention

Other

Type of artist intervention will be determined by the subject and the assigned artist.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

A Pilot Study of Creative Arts Interventions for Neurology Inpatients in the Epilepsy Monitoring Unit and the Headache Service

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 11, 2018
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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