Art in Improving Outcomes in Participants Undergo Surgery

Not Applicable

Terminated

• Conditions: Health Status Unknown
• Interventions: Procedure: Art Therapy; Other: Best Practice; Other: Questionnaire Administration

• Registration Number: NCT03688945
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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

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 Timeline

• Study Start: 2017-08-07
• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-28
• Primary Completion: 2019-11-27
• Study Completion: 2019-11-27
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (art sessions)	Art Therapy	Participants attend at least 1 session of viewing art pieces over 15 minutes every day for 2 years.
Arm II (standard of care)	Best Practice	Participants receive standard of care for 2 years.
Arm II (standard of care)	Questionnaire Administration	Participants receive standard of care for 2 years.
Arm I (art sessions)	Questionnaire Administration	Participants attend at least 1 session of viewing art pieces over 15 minutes every day for 2 years.

Primary Outcome Measures

Name	Time	Method
Mental health wellbeing score	Up to 2 years	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States