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临床试验/NCT05893680
NCT05893680已完成不适用

Comparison of the Effects of Online Games, Cold Applications and Placebo in Reducing Pain in Children Undergoing Orthopedic and Traumatology Surgery

İlke Karabıyık1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年8月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
1
主要终点
Statistical analysis

研究概览

简要总结

The 3 non-pharmacological methods of online gaming, cold application, and placebo were chosen to reduce postoperative pain in children undergoing orthopedic and traumatology surgery. The effect of these 3 non-pharmacological methods on pain reduction was measured and compared.

详细描述

This study was designed as a randomized controlled trial to compare the effects of cold application, online gaming, and placebo on postoperative pain in children.

The sample size of the study was determined as 160 children, considering a 5% alpha error rate, 90% power, and the probability of loss of data during data collection, using G*Power program (3.1.9.2.) According to this result, the population of the study is planned to be formed with 160 child patients, aged between 7-12, who are hospitalized in the Palace Lower Floor Orthopedics Service of Istanbul Metin Sabancı Baltalimanı Bone Diseases Training and Research Hospital. The 160 children who make up the sample will be randomly assigned to "online game and cold application", "online game", "cold application", and "placebo" groups, previously sorted as group 1, group 2, group 3, and group 4 by the lottery method. In the study, the intervention of the relevant group will be applied to each child during pain control in each group.

A randomization list consisting of 40 blocks of four, based on age, gender, and the extremity region where the operation was performed, was created (https://www.randomizer.org/#randomize) to assign the children participating in the study to the groups randomly.

After the children were assigned to the intervention groups homogeneously and randomly, the study was started.

Before applying any pain-reducing interventions to all children in all the intervention groups, pain assessment was conducted using the visual analog scale (VAS) at 4 hours after surgery. The child's parent was also asked to evaluate the child's pain independently using the same scale. In this way, pre-intervention pain assessment was performed. Later, the pain-reducing intervention specific to the group in which the child was randomized was applied to the child.

研究设计

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

入排标准

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

入选标准

  • Being in the 7-12 age group
  • Having undergone lower or upper extremity surgery
  • Receiving general anesthesia during surgery
  • Having a body temperature not higher than 37.5°C
  • Those who are hospitalized in the orthopedic service and agree to participate along with their parents.

排除标准

  • After the surgery, children who had intense pain in the first 4 hours and were given analgesics, children under 7 or over 12 years old, children with a fracture in the active arm for the online game group, children with a fever above 37.5°C, patients who were not fully recovered at 4 hours after the surgery and could not communicate, patients with mental motor development retardation, patients with plaster treatment for the cold application group, patients who received botulinum toxin injection during surgery and patients who underwent biopsy will be excluded from the study.

研究组 & 干预措施

Group to play online games

Experimental

The child's pain was evaluated 4 hours after the surgery, and then he/she was allowed to play an online game that he/she knew, loved, and wanted to play for 20 minutes.

干预措施: Group to play online games (Other)

Group that received cold application

Experimental

The child's pain was evaluated 4 hours after the surgery, and then a clean gauze wrapped cold gel pack was applied to the surgical site for 20 minutes.

干预措施: Group that received cold application (Other)

Group that received placebo

Placebo Comparator

The child in the relevant group had their pain evaluated 4 hours after the surgery, and then was given 2 cc of 0.9% saline (isotonic) solution intravenously, while being told that it was a painkiller administered to both the child and the parent.

干预措施: Group that received placebo (PHYSIOLOGICAL SALINE ISOTONIC 9 mg/ml AMPULE) (Drug)

"Group that played an online game and received cold application at the same time

Active Comparator

Pain assessment was performed on the child in the relevant group 4 hours after surgery, and then while playing an online game that the child knew, liked, and wanted to play, a clean gauze-wrapped cold gel pack was applied to the surgical site for cold therapy. The interventions lasted for 20 minutes.

干预措施: Group that played an online game and received cold application at the same time (Other)

结局指标

主要结局

Statistical analysis

时间窗: 8 months

The data will be analyzed by deciding on the relevant statistical method by evaluating whether the assumptions of parametric tests are met. The analysis results will be interpreted, and the relevant data will be recorded.

次要结局

  • Body weight(8 months)
  • Height(8 months)
  • pulse(8 months)
  • saturation(8 months)
  • respiration(8 months)
  • body temperature(8 months)

研究者

发起方
İlke Karabıyık
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

İlke Karabıyık

Nurse

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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