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Art in Improving Outcomes in Participants Undergo Surgery

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03688945
Enrollment
80
Registered
2018-09-28
Start date
2017-08-07
Completion date
2019-11-27
Last updated
2022-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Status Unknown

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.

Interventions

PROCEDUREArt Therapy

Attend art viewing sessions

OTHERBest Practice

Receive standard of care

OTHERQuestionnaire Administration

Ancillary studies

Sponsors

Roswell Park Cancer Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mental health wellbeing scoreUp to 2 yearsWill 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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026