EpilepsyNCT03520777
A Pilot Study of Creative Arts Interventions for Neurology Inpatients
A study testing Art Intervention in people with Epilepsy and Migraine, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Art Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2017to 30 Jun 2018
- 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
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Pilot Study of Creative Arts Interventions for Neurology Inpatients in the Epilepsy Monitoring Unit and the Headache Service
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.
- Being tested
- Art Intervention
- Medical subject headings
- Epilepsy, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art InterventionOther
Type of artist intervention will be determined by the subject and the assigned artist.
| Study group | Role | What they receive |
|---|---|---|
| Artist Intervention | Other | One of the three artists (visual artist, music therapist, creative writer) will work with subjects for up to 90 minutes. Receives: Other: Art Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, approximately 1 year
Secondary outcomes (5)
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.
Measured: Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).
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.
Measured: Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).
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.
Measured: Each patient will be assessed at baseline (Day 1) and after the intervention (approximately Day 3 - 21).
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.
Measured: Each patient as-needed medication use will be assessed after the arts intervention and until discharge from the hospital (approximately Day 3 - 21).
Length of hospital stay
Length of hospital stay will be calculated.
Measured: Each patient's admission duration (approximately 3 - 21 Days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start19 Sep 2017
- Primary completion1 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara K. Ronan, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520777
- Sponsor's protocol ID
- 30498
- Status last verified
- Jul 2018
- First submitted
- 13 Apr 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Creative Arts Interventions for Neurology Inpatients in the Epilepsy Monitoring Unit and the Headache Service
- ClinicalTrials.gov ID
- NCT03520777
- Acronym / sponsor ID
- 30498
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 11 May 2018 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artist Intervention | Other | Other: Art InterventionOne of the three artists (visual artist, music therapist, creative writer) will work with subjects for up to 90 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Art InterventionType of artist intervention will be determined by the subject and the assigned artist. | Other | Artist Intervention |
Primary outcome
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.
5 secondary outcomes
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 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 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 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).
Length of hospital stay
Time frame: Each patient's admission duration (approximately 3 - 21 Days).
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 18 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Intervention in people with Epilepsy and Migraine, run by Dartmouth-Hitchcock Medical Center 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 4 inclusion and 3 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 18 Jul 2018. 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?
Feasibility of conducting a creative arts intervention study (time frame: Through study completion, approximately 1 year). 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 18 Jul 2018.