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临床试验/NCT05756140
NCT05756140招募中不适用

Efficiency of Facial Expression Diagnostic System in Pain Assessment After Geriatric Surgery

Zonguldak Bulent Ecevit University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
68
试验地点
1
主要终点
Determination of the average scores from the "Numerical Rating Scale"

研究概览

简要总结

By integrating the methods used in the assessment of pain in geriatric surgery patients with literature, theory and research, this study aims to: evaluate the effectiveness of the facial diagnosis system in the evaluation of pain after geriatric surgery.

The research hypotheses are as follows:

H1: In the evaluation of pain after geriatric surgery, there is a concordance between the pain score evaluated by the patient and the pain score obtained from facial expression diagnostic system analysis.

H1: In the evaluation of pain after geriatric surgery, there is a correlation between the pain score evaluated by the nurse and the pain score obtained from the analysis of the facial expression diagnosis system.

H1: In the evaluation of pain after geriatric surgery, there is a correlation between the pain score evaluated by the patient and the pain score evaluated by the nurse.

详细描述

By integrating the methods used in the assessment of pain in geriatric surgery patients with literature, theory and research, this study aims to: evaluate the effectiveness of the facial diagnosis system in the evaluation of pain after geriatric surgery.

The number of patients in the groups will be analyzed based on one of the studies to be used in the study. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size is accepted as 0.8, it was seen that at least 68 patients would be sufficient for 80% power. In this way, the criteria sampling method will be used. Anticipated duration is one year.

The inclusion criteria of the patients in the study are as follows:

  • The patient is 65 years or older,
  • According to the American Society of Anesthesiologists (ASA) classification; Being in class II and III; ASA II: Patient with mild systemic disease, ASA III: Patient with severe systemic disease but not affecting activities of daily living.
  • Willingness to participate in the research,
  • The patient is awake and oriented after the surgery,
  • The patient is not discharged within the first 24 hours after the operation,

Data collecting:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • The patient is 65 years or older,
  • According to the American Society of Anesthesiologists (ASA) classification; Being in class -II and III; ASA II: Patient with mild systemic disease, ASA III: Patient with severe systemic disease but not affecting activities of daily living.
  • Willingness to participate in the research,
  • The patient is awake and oriented after the surgery,
  • The patient is not discharged within the first 24 hours after the operation,

排除标准

  • Not being willing to participate in the research,
  • The presence of any facial anomalies that may change the facial expression analysis of the patient,
  • The patient's regular use of opiates in the last 6 months,
  • The patient has undergone surgical intervention that requires not being in the prone or semifowler position,
  • The patient is not awake and oriented after the surgery,
  • Discharge of the patient within the first 24 hours after surgery.

结局指标

主要结局

Determination of the average scores from the "Numerical Rating Scale"

时间窗: 6 months

Numerical Rating Scale: Patients are asked to draw a number from 0 to 10, 0 to 20, or 0 to 100 that best fits pain intensity. Zero usually indicates "no pain", while the upper limit represents "unbearable pain". The patient and the nurse will be asked to give a pain score to the patient when immediately after the patient comes from the surgery and 1 hour after coming to the service.

Determination of the average scores from the "Wong Baker Facial Pain Scale"

时间窗: 6 months

Wong Baker Facial Pain Scale: It consists of 6 different facial expressions, starting with a smiling face and ending with a crying face. The patient and the nurse will be asked to give a pain score to the patient when immediately after the patient comes from the surgery and 1 hour after coming to the service.

次要结局

  • Machine learning will be provided using a computer-assisted facial expression recognition system.(12 months)

研究者

发起方
Zonguldak Bulent Ecevit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tülin KURT ALKAN

Doctoral Candidate in Surgical Nursing Science

Zonguldak Bulent Ecevit University

研究点 (1)

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