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Art in Improving Outcomes in Participants Undergo Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688945
Recruitment Status : Terminated (Art gallery dissembled- no research goals with new art.)
First Posted : September 28, 2018
Last Update Posted : February 25, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Health Status Unknown Procedure: Art Therapy Other: Best Practice Other: Questionnaire Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Art Heals - (the Effects of Art After Robot Assisted Surgery)
Actual Study Start Date : August 7, 2017
Actual Primary Completion Date : November 27, 2019
Actual Study Completion Date : November 27, 2019

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.
Procedure: Art Therapy
Attend art viewing sessions

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm II (standard of care)
Participants receive standard of care for 2 years.
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Mental health wellbeing score [ Time Frame: 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 :
  1. Reduced pain: NRS [ Time Frame: Up to 2 years ]
    Will assess by using a validated visual numeric rating scale - corresponding to pain experienced over 24 hours

  2. Anxiety score (patient) [ Time Frame: Up to 2 years ]
    Will be assessed by using State Trait Inventory for Adults (STAI). - A self reporting survey which measures anxiety.

  3. Hope score [ Time Frame: Up to 2 years ]
    Will be assessed by using Herth Hope Index. A 12 item self reporting questionnaire measuring the sense of hope.

  4. Change in blood pressure [ Time Frame: Up to 2 years ]
    Will assess systolic and diastolic pressure . Parameters will be collected from the patient chart

  5. change in recovery of bowel function [ Time Frame: Up to 2 years ]
    Evaluated using Parameters collected from the patient chart



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688945


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Khurshid Guru Roswell Park Cancer Institute
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03688945    
Other Study ID Numbers: I 43217
NCI-2018-00457 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 43217 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020

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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