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临床试验/NCT05119621
NCT05119621已完成不适用

The Effect of TENS Application Applied Before Mobilization on Pain in Children With Abdominal Surgery: A Randomized Controlled Trial

KTO Karatay University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

The aim of the study which was planned in a randomized controlled experimental design, it was aimed to determine the effect of Transcutaneous Electrical Nerve Stimulation (TENS) application on pain level before mobilization in the postoperative period in children.

详细描述

Children can often experience chronic muscle, bone, joint pain, headache and abdominal pain, and acutely experience pain due to postoperative and procedural procedures. Effective management of childhood pain is emphasized as a health priority by the World Health Organization and pain communities. The findings of various epidemiological studies emphasized that a significant proportion (49% to 64%) of children receiving treatment in a hospital setting received inadequate pain management services despite the increase in available knowledge and treatments. One of the situations in which pediatric patients encounter acute pain is the postoperative period. Mobilization is delayed in patients who cannot provide adequate pain control, and accordingly, serious complications such as impaired tissue perfusion, atelectasis and deep vein thrombosis may develop. There are studies on the use of TENS, one of the methods used in non-pharmacological pain management, in postoperative pain management in adults. Studies on pain management in children for TENS application are very limited today. There was no evidence for the effectiveness of TENS application applied before mobilization in the postoperative period in children.

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
Single (Participant)

盲法说明

Single Blinded

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Be in the 7-12 age range
  • •Abdominal surgery indication (appendicitis or inguinal region surgery)
  • •Volunteering to participate in the study
  • •Receiving monotherapy treatment for epilepsy
  • •To be able to communicate in Turkish

排除标准

  • •Administering analgesic therapy other than routine administration
  • •Patients who have difficulties in mobilization/complications during the operation will be excluded from the study.

研究组 & 干预措施

TENS application

Experimental

TENS application will be applied to the experimental group before mobilization after abdominal surgery. TENS will be applied for an average of 40 minutes.

干预措施: TENS application (Device)

Standard pain management

No Intervention

The control group will receive standard pain treatment without any intervention. The group will not receive any other intervention.

结局指标

主要结局

Visual Analogue Scale

时间窗: (Second measurement-1 minute on average before mobilization)

The scale consists of a horizontal or vertical ruler, 10 cm or 100 mm in length, showing "painlessness" at one end and "the most severe pain" at the other end. For children over the age of six, this scale is reported to be an easy-to-understand and easy-to-apply scale.

Child Introduction Form

时间窗: (First measurement-After the operation, when the patient is taken to her bed and fully awakened)

The introductory information form was prepared by the researcher in line with the literature information. The introductory information form consists of 10 questions covering the characteristics of children and their families (age, gender, parental age, education level, family type, income status), and operational characteristics (patient's complaints, type of surgery, previous operation experience).

The Wong-Baker Faces Pain Rating Scale

时间窗: (Second measurement-1 minute on average before mobilization)

In this scale, there are six facial expressions representing the increasing pain intensity from 0 to 5 from left to right. Six facial expressions are scored between 0-5 points from left to right (0 points = very happy/no pain, 5 points = indicates the most severe pain). As the score obtained from the scale increases, pain tolerance decreases, and as the score decreases, the tolerance increases.

Children's Fear Scale

时间窗: (Second measurement-1 minute on average before mobilization)

The mean score of the scale, which was translated into Turkish by five independent linguists, was 1.9 ± 0.1 (min=0, max=4). The scale can also be scored by the parent and the researcher. The scale consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety).

Children's Fear Scale

时间窗: (First measurement-40 minutes on average before mobilization)

The mean score of the scale, which was translated into Turkish by five independent linguists, was 1.9 ± 0.1 (min=0, max=4). The scale can also be scored by the parent and the researcher. The scale consists of five drawn facial expressions ranging from a neutral expression (0=no anxiety) to a frightened face (4=severe anxiety).

Visual Analogue Scale

时间窗: (First measurement-40 minutes on average before mobilization)

The scale consists of a horizontal or vertical ruler, 10 cm or 100 mm in length, showing "painlessness" at one end and "the most severe pain" at the other end. For children over the age of six, this scale is reported to be an easy-to-understand and easy-to-apply scale.

The Wong-Baker Faces Pain Rating Scale

时间窗: (First measurement-40 minutes on average before mobilization)

In this scale, there are six facial expressions representing the increasing pain intensity from 0 to 5 from left to right. Six facial expressions are scored between 0-5 points from left to right (0 points = very happy/no pain, 5 points = indicates the most severe pain). As the score obtained from the scale increases, pain tolerance decreases, and as the score decreases, the tolerance increases.

次要结局

未报告次要终点

研究者

发起方
KTO Karatay University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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