Art in Improving Outcomes in Participants Undergo Surgery

Health Status Unknown Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03688945
• Other study ID #: I 43217
• Secondary ID: NCI-2018-00457I
• Status: Terminated
• Phase: N/A
• Start date: August 7, 2017
• Est. completion date: November 27, 2019

Study information

• Verified date: July 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: November 27, 2019
• Est. primary completion date: November 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Health Status Unknown

Intervention

Procedure:
• Art Therapy
Attend art viewing sessions

Other:
• Best Practice
Receive standard of care
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduced pain: NRS	Will assess by using a validated visual numeric rating scale - corresponding to pain experienced over 24 hours	Up to 2 years
Secondary	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
Secondary	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
Secondary	Change in blood pressure	Will assess systolic and diastolic pressure . Parameters will be collected from the patient chart	Up to 2 years
Secondary	change in recovery of bowel function	Evaluated using Parameters collected from the patient chart	Up to 2 years