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CompletedNCT03520777Updated Jul 18, 2018

A Pilot Study of Creative Arts Interventions for Neurology Inpatients

An interventional study of Art Intervention in Epilepsy and Migraine, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-18.

Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Sep 2017, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Epilepsy
  • Migraine

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03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 33 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Other
    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

Interventions

  • OtherArt Intervention

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, approximately 1 year

Secondary outcomes

  1. 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.

    Time frame: Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).

  2. 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.

    Time frame: Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).

  3. 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.

    Time frame: Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).

  4. 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.

    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).

  5. Length of hospital stay

    Length of hospital stay will be calculated.

    Time frame: Each patient's admission duration (approximately 3 - 21 Days).

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Study locations

1 site
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03520777
Lead sponsor
Dartmouth-Hitchcock Medical Center
Responsible party
Lara K. Ronan (Principal Investigator, Dartmouth-Hitchcock Medical Center) — Principal investigator
First posted
May 11, 2018
Start date
Sep 19, 2017
Primary completion
Jun 1, 2018
Completion
Jun 30, 2018
Last update
Jul 18, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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