跳至主要内容
临床试验/NCT04401891
NCT04401891终止不适用

The Benefit of Formal Pre-operative Education to Patient Satisfaction, Pain and Function

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年2月5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
26
试验地点
1
主要终点
PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety subtest -- change is being assessed

研究概览

简要总结

The investigators want to determine if delivering formal preoperative education to patients helps the patients with post operative pain, function and overall satisfaction. Education would cover surgery, post operative activities of daily living, pain and edema management, duration of recovery and any expected therapy they might need. All participants will receive a pre and post operative questionnaire to determine level of understanding of anticipated needs and barriers due to surgery. Group one will receive formal education from an occupational therapist or physical therapist while Group two will receive only standard education in the MD clinic.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older,
  • English as Primary language,
  • scheduled to have orthopedic upper extremity surgery.

排除标准

  • less than 18 years
  • Conservative management or non operative management of orthopedic upper extremity surgery

研究组 & 干预措施

Formal Pre-operative education/therapy prior to surgery

Experimental

干预措施: Formal pre-operative education (Behavioral)

Routine Pre-Operative Education in MD office prior to surgery

No Intervention

结局指标

主要结局

PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety subtest -- change is being assessed

时间窗: prior to surgery and two weeks post surgery

Bell Curve scale for scoring:A score of 50 is the average amount of anxiety in the general public. A score above 60 the patient has significant anxiety

MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) Pre-Operative

时间窗: prior to surgery

1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable

PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function Subtest -- change is being assessed

时间窗: prior to surgery and two weeks post surgery

Bell curve scale for scoring: A score of 50 is the average amount of physical function and/or upper extremity function in the general population. A score below 40 would be poorer function, whereas, a score above 60 would be better function than the general population.

PROMIS (Patient-Reported Outcomes Measurement Information System) Depression subtest -- change is being assessed

时间窗: prior to surgery and two weeks post surgery

Bell shape curve scoring: A score of 50 is the average amount for depression in the general public. A score above 60 corresponds to a score of 10 on the Patient Health Questionnaire (PHQ)-9 scale, which is the cutoff with the highest sensitivity and specificity to detect a diagnosis of moderately severe major depression.

PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference subtest -- change is being assessed

时间窗: prior to surgery and two weeks post surgery

Bell shape curve scoring: The higher the score above 50 the more the pain the lower the score below 50 the less the pain

PROMIS (Patient-Reported Outcomes Measurement Information System)Upper Extremity Function subtest -- change is being assessed

时间窗: prior to surgery and two weeks post surgery

Bell shape curve scoring:A score of 50 is the average amount of physical function and/or upper extremity function in the general population. A score below 40 would be poorer function, whereas, a score above 60 would be better function than the general population.

MODEMS (Musculoskeletal Outcomes Data Evaluation Management Scale) post operative

时间窗: 2 weeks post surgery

1 to 5 scale with 1 being not at all likely and 5 being extremely likely. Also is a 6 for not applicable

Pain Scale

时间窗: prior to surgery and 2 weeks post surgery

0 to 10 likert scale. 0 being no pain and 10 being worst pain possible

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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