Art in Improving Outcomes in Participants Undergo Surgery

Art Heals - (the Effects of Art After Robot Assisted Surgery)

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.

Study Overview

• Status: Terminated
• Conditions: Health Status Unknown
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Procedure: Art Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (art sessions); Participants attend at least 1 session of viewing art pieces over 15 minutes every day for 2 years.	Other: Questionnaire Administration; Ancillary studies; Procedure: Art Therapy; Attend art viewing sessions
Active Comparator: Arm II (standard of care); Participants receive standard of care for 2 years.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive standard of care; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental health wellbeing score	Will be assessed by using a Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). This is a 14 item scale with 5 response categories that cover both feeling and functioning aspects of mental wellbeing.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced pain: NRS	Will assess by using a validated visual numeric rating scale - corresponding to pain experienced over 24 hours	Up to 2 years
Anxiety score (patient)	Will be assessed by using State Trait Inventory for Adults (STAI). - A self reporting survey which measures anxiety.	Up to 2 years
Hope score	Will be assessed by using Herth Hope Index. A 12 item self reporting questionnaire measuring the sense of hope.	Up to 2 years
Change in blood pressure	Will assess systolic and diastolic pressure . Parameters will be collected from the patient chart	Up to 2 years
change in recovery of bowel function	Evaluated using Parameters collected from the patient chart	Up to 2 years

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Khurshid Guru, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2017
• Primary Completion (Actual): November 27, 2019
• Study Completion (Actual): November 27, 2019

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: I 43217 (Other Identifier: Roswell Park Cancer Institute); NCI-2018-00457 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No