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临床试验/NCT03688945
NCT03688945终止不适用

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

Roswell Park Cancer Institute1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年8月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
80
试验地点
1
主要终点
Mental health wellbeing score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Arm I (art sessions)

Experimental

Participants attend at least 1 session of viewing art pieces over 15 minutes every day for 2 years.

干预措施: Art Therapy (Procedure)

Arm I (art sessions)

Experimental

Participants attend at least 1 session of viewing art pieces over 15 minutes every day for 2 years.

干预措施: Questionnaire Administration (Other)

Arm II (standard of care)

Active Comparator

Participants receive standard of care for 2 years.

干预措施: Best Practice (Other)

Arm II (standard of care)

Active Comparator

Participants receive standard of care for 2 years.

干预措施: Questionnaire Administration (Other)

结局指标

主要结局

Mental health wellbeing score

时间窗: 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.

次要结局

  • Hope score(Up to 2 years)
  • Change in blood pressure(Up to 2 years)
  • Anxiety score (patient)(Up to 2 years)
  • Reduced pain: NRS(Up to 2 years)
  • change in recovery of bowel function(Up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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