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临床试验/NCT04390828
NCT04390828已完成不适用

Effectiveness of Guided Imagery Meditation in Patients With Laparoscopic Gallstone Surgery

National Yang Ming Chiao Tung University Hospital2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2019年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
pain score

研究概览

简要总结

Guided image meditation has been shown to alter the functional circuits of the brain to alleviate pain by mediating breathing and thoughts. Therefore, the purpose of this study is to investigate whether the intervention with guided image meditation after laparoscopic cholecystectomy can effectively alleviate postoperative pain, reduce anxiety, promote sleep quality, and increase pain control satisfaction for the patients with gallstones.

详细描述

Gallstone is the most common digestive tract disease in general surgical wards. The incidence of gallstones in Chinese is about 5-10%, and the patients often seek hospital treatment due to abdominal pain. At present, most gallstones are treated with laparoscopic cholecystectomy, and postoperative pain is one of the most troublesome problems for surgical patients. However, up to 90% of patients undergoing abdominal surgery still experience moderate to severe pain, which not only affects the patient's physical recovery, but also causes psychological anxiety. Therefore, it is important to provide good postoperative pain management. Guided image meditation has been shown to alter the functional circuits of the brain to alleviate pain by mediating breathing and thoughts. Therefore, the purpose of this study is to investigate whether the intervention with guided image meditation after laparoscopic cholecystectomy can effectively alleviate postoperative pain, reduce anxiety, promote sleep quality, and increase pain control satisfaction for the patients with gallstones.

This study used 2×2 pre-test and post-test randomized control tests with randomized, single-blind, experimental study design. The research subjects were recruited from the general surgical ward of the North District Teaching Hospital. The study questionnaire included the assessment of pain levels using the 11-point Numeric Rating Scale (NRS-11) and the 11-face Face Pain Scale (FPS-11), the degree of anxiety using the Chinese version of Beck Anxiety Inventory (BAI), pain control satisfaction using Visual Analogue Scales (VAS), and sleep quality using the Chinese Pittsburgh Sleep Quality Index (CPSQI). The number of samples in this study was calculated by G-Power 3.1.2 statistical software. At least 68 samples were collected and grouped by random allocation, with 34 each for the control group (conventional scheme) and the experimental group (guided image meditation intervention). After the pre-test, the two groups were post-tested on the first postoperative day. The data obtained in this study were statistically analyzed by statistical software SPSS 22.0 for descriptive statistics including number of assignments, percentage, mean, standard deviation, Maximum and Minimum. Inferential statistical analysis by analysis of variance (ANOVA), Chi-square test, independent sample t-test, logistic regression, Pearson's correlation, repeated measures ANOVA and Generalized Estimating Equation (GEE) tested the pre-test and post-test results of the experimental group and the control group to compare the difference between the two groups in pain index, anxiety level, sleep quality and pain control satisfaction.

This study intended to use the characteristics of the guided image meditation being easy to learn and easy to operate and the evidence-based measures to alleviate postoperative pain, reduce anxiety, promote sleep quality and improve post-surgical pain control satisfaction to prove the empirical effect of guided image meditation in clinical care. It is hoped to provide an empirically based interventional effect to improve the problems associated with patients after laparoscopic surgery and improve the quality of life of patients after surgery. The results of this paper are expected to be published in domestic and foreign journals, so as to add to empirical academic literature and to be shared by medical staff for increasing new knowledge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • at least 20 years old, and diagnosed as having gallstones and had laparoscopic cholecystectomy
  • conscious, can communicate in Mandarin and Taiwanese; and have agreed to participate in the study.

排除标准

  • with hearing or vision severely impaired
  • cognitive mental disorder, such as mental illness
  • who are unwilling to participate in this study.

结局指标

主要结局

pain score

时间窗: up to 12 months

11-point Pain Numbered Rating Scale, uses 11 points from 0 to 10 to describe the intensity of pain, 0 point means no pain, points increase as pain increases, 10 points means the most severe pain. Faces pain scale-11, a score of 1-3 points shows mild pain; 4-6 points indicate m moderate pain; 7-10 points indicate severe pain. The higher the pain score, the higher the pain.

anxiety

时间窗: up to 12 months

Beck Anxiety Inventory, a total of 21 items describe anxiety symptoms and measure 21 indicators of anxiety. A score of 0-9 points means "normal", 10-18 points indicate "mild" anxiety, 19-29 indicate "moderate" anxiety, and 30-63 points indicate "severe" anxiety.

pain control satisfaction

时间窗: up to 12 months

Visual Analogue Scale, this study used Visual Analogue Scale as a scale to assess patient satisfaction with pain control. It is explained to the patient that 0 cm means no pain, 10 cm means very pain, and moving from the left to the right means the pain is higher.

sleep quality

时间窗: up to 12 months

Chinese version of Pisttsburgh Sleep Quality Index, is the Chinese version of the Pittsburgh Sleep Quality Each aspect is scored 0-3points, so the total score is 21points. The average score of 5 points is the demarcation point of sleep quality. The higher the score, the worse the sleep quality.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi-Ju Lu

Principal Investigator

National Yang Ming Chiao Tung University Hospital

研究点 (2)

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