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临床试验/NCT05882929
NCT05882929Unknown不适用

The Effect of Distraction Methods on Pain Level and Physiological Parameters in the Postoperative Period of Pediatric Patients Undergoing Outpatient Surgery: A Randomized Controlled Study

Selcuk University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
physiological parametres of the child: body temperature level

研究概览

简要总结

The aim of the study is to examine the effects of distraction methods such as watching cartoons and ball squeezing on the level of pain and physiological parameters in the postoperative period in children aged 6-12 years who have outpatient surgery. The research is a randomized controlled trial. The sample number was determined as 40 children (total 120) in each group. Information Form, Physiological Parameters Follow-up Form, Wong-Baker Faces Pain Scale will be used to collect research data. In the initiative group, two attempts will be implemented, namely watching cartoons and squeezing the ball. Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed. In the control group, the 10th and 20th minute physiological parameters and the Wong-Baker Faces Pain Scale will be evaluated after the child comes to the service after the operation and is prepared for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). In the analysis of study data; chi-square test for descriptive statistics, chi-square test for repeated measurements, single factor analysis of variance, Mann-Whitney U test and Friedman will be used. In the study, values at the p<0.05 level were considered statistically significant.

详细描述

The aim of the study is to examine the effects of distraction methods such as watching cartoons and ball squeezing on the level of pain and physiological parameters in the postoperative period in children aged 6-12 years who have outpatient surgery. The research is a randomized controlled trial. The sample number was determined as 40 children (total 120) in each group. Information Form, Physiological Parameters Follow-up Form, Wong-Baker Faces Pain Scale will be used to collect research data. In the initiative group, two attempts will be implemented, namely watching cartoons and squeezing the ball. Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed. In the control group, the 10th and 20th minute physiological parameters and the Wong-Baker Faces Pain Scale will be evaluated after the child comes to the service after the operation and is prepared for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). In the analysis of study data; chi-square test for descriptive statistics, chi-square test for repeated measurements, single factor analysis of variance, Mann-Whitney U test and Friedman will be used. In the study, values at the p<0.05 level were considered statistically significant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Single (participant, outcomes assessor)

入排标准

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

入选标准

  • •Children aged 6-12 years
  • •Children with day surgery surgery
  • •Children with American Society of Anesthesiologists classification (ASA) I-II (ASA score is given in the preoperative period by the anesthesiologist)
  • •Parents who volunteered to participate in the study
  • •Turkish speaking children

排除标准

  • •Children who have had previous surgery
  • •Children with the American Society of Anesthesiologists classification (ASA) III
  • •Children with congenital anomalies, psychiatric, neurological and chronic diseases

研究组 & 干预措施

Experiment 1: Watching Cartoons

Experimental

Watching Cartoon Movies will be performed after the child comes to the service after the operation and prepares for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.). Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed.

干预措施: Watching Cartoons (Other)

Experiment 1: ball spin

Experimental

ball squeezing will be applied after the child comes to the service after the operation and the postoperative period preparation is made (taking the vital signs, putting on the clothes, controlling the bleeding, telling the feeding time, etc.). Interventions will be implemented for a total of 15 minutes. Physiological Parameters Follow-up Form and Wong-Baker Faces Pain Scale will be filled in before the interventions are applied, 10 minutes during the intervention and 5 minutes after the intervention is completed.

干预措施: ball spin (Other)

Control

No Intervention

In the control group, the 10th and 20th minute physiological parameters and Wong-Baker Faces Pain Scale will be evaluated after the child comes to the service after the operation and is prepared for the postoperative period (taking vital signs, putting on clothes, controlling bleeding, telling the feeding time, etc.).

结局指标

主要结局

physiological parametres of the child: body temperature level

时间窗: Just before the interventions and 5 minutes after the intervention

body temperature change

physiological parametres of the child: respiratory rate

时间窗: Just before the interventions and 5 minutes after the intervention

respiratory rate change

physiological parametres of the child: oxygen saturation (SpO2)

时间窗: Just before the interventions and 5 minutes after the intervention

SpO2 level change

physiological parametres of the child: peak heart rate

时间窗: Just before the interventions and 5 minutes after the intervention

heart rate change

pain level of children

时间窗: Just before the interventions and 5 minutes after the intervention

Wong Baker Pain Faces Scale mean score Wong-Baker Pain Faces Scale is widely used with people ages three and older, not limited to children. This self-assessment tool must be understood by the patient, so they are able to choose the face that best illustrates the physical pain they are experiencing. It is a tool to be used by a third person, parents, healthcare professionals, or caregivers, to assess the patient's pain. The scale is 0-10 scale. The six illustrated faces on the cards show a range of emotions, from a smiling face (0 'no pain) to a crying face (10 "worst pain"). 0 indicates no pain, 10 indicates the most severe pain. It is measured before, at the 10th minute and after the intervention.

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

Sevinc Akkoyun

assistant professor

Selcuk University

研究点 (1)

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