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临床试验/NCT06340776
NCT06340776已完成不适用

The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With Hysterectomy: a Randomized Controlled Study

Istanbul Medipol University Hospital2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2021年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
gas output and stool formation of the participants

研究概览

简要总结

Aim This randomized controlled trial was conducted to evaluate the effect of acupressure application on gastrointestinal functions and pain after abdominal hysterectomy.

Materials and methods After undergoing hysterectomy, 39 women were randomised into acupressure (n=19), and control groups (n=20). Women in the acupressure group received acupressure on the mide meridian (ST36), the heart meridian (HT7), large intestine meridian (LI4), intersection of the spleen, liver and kidney meridians 6(SP6) and pericardium meridian (PC6) acupoints 30 min after admission to the clinic, for a period of 15 min, whereas those in the sham group received acupressure on locations 1-1.5 cm away from these points. The control group received standard treatment. The patient information form, Visual analog scale, the Rhodes Index of Nausea, Vomiting and Retching, and daily follow-up form were used for data collection.

详细描述

The study consists of two groups: control and experimental groups. Those who received acupressure application were called the experimental group, and patients who received routine post-operative care were called the control group. Acupressure application was applied to the experimental group at the third and twenty-fourth hours after surgery. The control group was evaluated without any application for two days. For the acupressure application, planning was made to adjust the temperature, light, and silence of the environment and to pay attention to privacy. 5 points that positively affect gastrointestinal functions and pain were selected (SP6, ST36, PC6, HT7, LI4). The duration of the session was determined to be approximately 18-20 minutes, depending on the preparation and pressure time to be applied on the 5 selected points (a total of 10 points were applied since each point will also be applied to its counterpart in the other extremity). Acupressure application was applied to each point for 1.5 minutes (1.5*10=15 minutes). The application was applied to a total of 39 women, 19 experimental and 20 control. No treatment was performed on the women in the control group other than routine post-operative care.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women with Post hysterectomy operation
  • Turkish women over the age of 18 years
  • had no wounds or ulcerations in the areas where acupressure would be applied on the arms' legs
  • had no intestinal obstruction, irritable bowel syndrome, inflammatory bowel disease, or abdominal herniation due to bowel cancer
  • had defecated at least three times a week in the last trimester
  • had stools of normal consistency; did not develop any serious postoperative complications

排除标准

  • had chronicle constipation, fecal incontinence or diarrhea
  • who used laxatives, suppositories oath enemas,
  • who were immobilized,
  • who did not agree to participate in the study,
  • who did not speak Turkish.

结局指标

主要结局

gas output and stool formation of the participants

时间窗: 18 month

This is the form in which the patients' bowel sounds, flatulence time are defecation time are recorded for two days after hysterectomy.

the score of nausea, vomiting and retching experiences

时间窗: 18 month

To evaluate the 24-hour nausea and vomiting status, the Rhodes Nausea, Vomiting and Retching Index was used to evaluate postoperative nausea and vomiting.In this scale, the number of nausea, vomiting, and retching of individuals and their distress are measured by Likert type assessment. This five-point Likert-type scale consists of eight items that measure the number and severity of nausea, vomiting, and retching in the last 24 hours. For each response, "never vomited" is scored as "0" or "never felt it", "7 or more" "severe" "more than 6 hours" "too much" is scored as 4. Items 1, 3, 6, and 7 must be reversed to score the Rhodes Index of Nausea, Vomiting, and Retching. The highest value that can be obtained from the scale is 32, meaning that as the score increases, the level of distress also increases. The scale has three subscales: symptom (nausea, vomiting, and retching) experience, occurrence, and distress.

postoperative pain

时间窗: 18 month

Pain intensity was evaluated with the Numerical Pain Intensity Scale, which is a single-criteria and subjective individual pain assessment method and aims to explain the severity of the patient's pain with numbers. The starting point of the scale, which consists of a horizontal line, is "0" or "no pain", and the ending point is "10" or "unbearable pain". There are numbers from 0 to 10 at equal intervals on the horizontal line, where 1-3 is defined as mild pain, 4-6 as moderate pain, and 7-10 as severe pain.

次要结局

  • Diastolic blood pressure(18 month)
  • Systolic Blood pressure(18 month)
  • Heart rate(18 month)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

YELİZ YILDIRIM VARIŞOĞLU

Prof. Asist.

Istanbul Medipol University Hospital

研究点 (2)

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