Creative Arts II Study

NCT03994718 | Completed

• 1 other identifier: D19124
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the impact of music, visual art, or creative writing on quality of life measures for epilepsy patients.

Conditions

Epilepsy

Keywords

art; music; visual art; writing; epilepsy

Outcome Measures

Primary Outcomes (2)

• Change in participant Quality of Life (QOLIE-10) scores before and after the interventions.

  Change in quality of life will be calculated using the QOLIE-10 questionnaire responses.The QOLIE-10 includes 10 questions with a total score range of 10 - 51. The score will be calculated by the sum of scores for all questions divided by the number of items answered. Thus, if a patient skipped an item, it is not reflected in the total score. A lower score indicates a higher quality of life, and a higher score indicates a lower quality of life.

  Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).

• Change in participant Distress scores before and after the interventions.

  Change in distress will be calculated using the Distress scale. The Distress scale asks patients to rate their distress on a scale from 0 - 10, with 0 meaning "no distress" and 10 meaning "extreme distress." Lower scores indicate less distress.

  Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).

Secondary Outcomes (6)

• Change in participant Patient Health Questionnaire (PHQ-9) scores before and after interventions.

  Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).

• Change in participant Generalized Anxiety Disorder (GAD-7) scores before and after interventions.

  Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).

• Change in EEG spike frequency before, during, and after the intervention while participant is admitted to the DHMC epilepsy inpatient service.

  Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).

• Change in seizure frequency from baseline to end of follow-up

  Each participant will be assessed at baseline (Day 1) and after the inpatient intervention (approximately Day 3 - 21) and at baseline (Day 1) and after the follow-up remote interventions (approximately 8 weeks after discharge).

• Qualitative analysis to identify themes in the creative writing and visual art subject matter.

  After the inpatient intervention (approximately Day 3 - 21) and after each follow-up remote intervention (approximately 8 weeks after discharge).

Study Arms (3)

Music

EXPERIMENTAL

The musician will either offer music that can either be played for the participant or an instrument so they can experience playing themselves. The duration of the intervention will be determined by participant interest and tolerance, but not to exceed 60 minutes. The outpatient music intervention will consist of providing a recording of similar music for the participant to listen to for at least 30 minutes per week, along a with telephone call session with the music therapist.

Other: Music intervention

Visual art

EXPERIMENTAL

The creative visual artist will assess interest in spending time using the materials provided. Participants will be offered watercolor painting, drawing, or adult coloring. There will be a guided activity based on their art making preference. A standardized prompt will be utilized for both writing and visual art sessions. The duration of the intervention will be determined by participant interest and tolerance, but not to exceed 60 minutes. For remote follow-up sessions, participants will be supplied with a small art kit to use at home.

Other: Visual arts intervention

Creative writing

EXPERIMENTAL

The writer will ask the participant about their interests and experiences in writing or storytelling. The following options are offered; introduction to journaling, storytelling or writing exercises with prompts to get started, interactive writing or storytelling activities. For participants who are unable to write or prefer not to, the writer can scribe their words on a laptop and print them out. The duration of the intervention will be determined by participant interest and tolerance, but not to exceed 60 minutes. For follow-up sessions, participants will be supplied with a journal.

Other: Creative writing intervention

Interventions

Music intervention OTHER

The music therapist will work with subjects for up to 60 minutes each session.

Music

Visual arts intervention OTHER

The visual artist will work with subjects for up to 60 minutes each session.

Visual art

Creative writing intervention OTHER

The creative writer will work with subjects for up to 60 minutes each session.

Creative writing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Scheduled for admission to the Dartmouth-Hitchcock Medical Center Epilepsy Monitoring Unit for diagnostic Video/EEG monitoring
• Capable of giving informed consent.
• Able to follow instructions

You may not qualify if:

• Active psychiatric illness that would interfere with participation with the artist.
• Active general medical condition that would impair the participant's consciousness or ability to participate.
• Any other reason that, in the opinion of the investigator, would exclude the participant from successful participation in the study.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Endowment for the Arts, United States: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: June 21, 2019
• Study Start: September 30, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-06

Locations

US (1)