Art in Improving Outcomes in Participants Undergo Surgery

NCT ID: NCT03688945

Last Updated: 2022-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2019-11-27

Brief Summary

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This trial studies how well art works in improving outcomes in participants who are undergoing surgery. Exposure to art may help to improve clinical and psychological outcomes.

Detailed Description

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PRIMARY OBJECTIVES:

I. Investigate through evidence-based randomized controlled trial the effect of exposure to art during the perioperative period on the outcome of surgical outcomes II. Assess patient response to artwork and investigate the correlation of patient response with the clinical outcomes of the patients.

III. Measure cognitive changes that may occur for patients based on art exposure.

OUTLINE: Participants are randomized into 1 of 2 arms.

ARM I: Participants attend at least 2 sessions of viewing art pieces over 15 minutes every day for 2 years.

ARM II: Participants receive standard of care for 2 years.

Conditions

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Health Status Unknown

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (art sessions)

Participants attend at least 1 session of viewing art pieces over 15 minutes every day for 2 years.

Group Type EXPERIMENTAL

Art Therapy

Intervention Type PROCEDURE

Attend art viewing sessions

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (standard of care)

Participants receive standard of care for 2 years.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard of care

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Art Therapy

Attend art viewing sessions

Intervention Type PROCEDURE

Best Practice

Receive standard of care

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy

Eligibility Criteria

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Inclusion Criteria

* Ambulant inpatients that will stay for at least 2 days postoperatively and do not require continuous monitoring
* All races and ethnic groups are eligible for this study

Exclusion Criteria

* Patients with altered mental status, psychiatric illness, debilitating pain, blind patients, or those who require continuous monitoring postoperatively will be excluded from the study
* Adult unable to consent, individuals who are not yet adults, pregnant women or prisoners
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khurshid Guru

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

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Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2018-00457

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 43217

Identifier Type: OTHER

Identifier Source: secondary_id

I 43217

Identifier Type: -

Identifier Source: org_study_id

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