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临床试验/NCT06571123
NCT06571123已完成不适用

The Effect of Interactive Floor on Postoperative Pain and Mobilization of Children; Randomized Controlled Trial

Istanbul Aydın University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年10月7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
84
试验地点
2
主要终点
Postoperative Pain Score

研究概览

简要总结

This research is planned to examine the effect of "interactive floor" on post-operative pain and mobilization in children within the scope of diversion method.

Research Question: Does the interactive floor affect children's post operative pain and mobilization?

Hypotheses of the Study:

H0: There is no difference between the postoperative pain score and mobilization time of children mobilized on the interactive floor and children mobilized with routine applications.

H1: Children mobilized on the interactive floor have lower pain scores than children in the control group.

H2: Children mobilized on the interactive floor have longer mobilization times than children in the control group.

H3: Children mobilized on the interactive floor have lower peak heart rate than children in the control group.

H4: Oxygen saturation of children mobilized on the interactive floor is higher than children in the control group.

详细描述

Pre-Mobilization:

The data for the child and family in the Interactive floor group and the control group who agreed to participate in the study and whose consent was obtained will be recorded by the researcher in the 'Child and Family Introductory Information Form' before mobilization with the patient file and face-to-face interview technique. Immediately before the 1st, 2nd and 3rd mobilizations of the child participating in the study in the postoperative period, pain score, peak heart rate and oxygen saturation values will be recorded without the child getting out of bed (while resting in bed).

During Mobilization:

Experimental group: Mobilization of children in this group will be provided on the interactive floor installed in the relevant ward. During the 1st, 2nd and 3rd mobilization, the child will be accompanied by the parent, nurse and researcher. In addition, during the 1st, 2nd and 3rd mobilization (the mobilization time will be evaluated by taking into account the time from the child getting out of bed to returning to bed), the mobilization time of the children will be measured with a stopwatch by an observer nurse who is not involved in the study and recorded in the data collection form. The mobilization time will depend on the child's own will and no restrictive intervention will be made by the researcher. In addition, pain scores, peak heart rate and oxygen saturation values will be recorded during the 1st, 2nd and 3rd mobilization (after the child has finished walking and before/while standing on the bed).

Control group: Mobilization of children in this group will be provided in the corridor, which is the routine of the relevant service, and they will be prevented from seeing the interactive floor before mobilization. Children in this group will be allowed to use the interactive floor in their mobilization after their 3rd mobilization.

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
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Speak and understand Turkish
  • •Children whose parents agreed to participate in the study,
  • •Between 3 and 6 years old,
  • •Mobilization for the first time after surgical intervention
  • •No previous experience with other surgical procedures
  • •Ability to walk independently
  • •Children with vesico-uretero renal reflux, torsion of the ovarian pedicle of the ovary and fallopian tube, hypospadias, hirschsprung's disease, undescended testis, persistent cloaca, hydronephrosis, ureteropelvic junction obstruction, appendicitis, anus atresia/stenosis/fistula, biliary atresia, circumcision, phimosis and paraphimosis, post-traumatic surgery

排除标准

  • •Daily surgical procedures performed
  • •Having a health problem that prevents him/her from walking
  • •Serious complications after the operation
  • •Having any visual, auditory and mental problems
  • •The physician reports a problem that may prevent him/her from walking

研究组 & 干预措施

Experimental Group: group using interactive floor

Experimental

Postoperative mobilization of children in this group will be provided on the interactive floor installed in the relevant ward.

干预措施: İnteractive floor (Other)

Control Group

No Intervention

The postoperative mobilization of children in this group will be provided in the corridor, which is the routine of the relevant service, and they will be prevented from seeing the interactive floor before mobilization. Children in this group will be allowed to use the interactive floor in their mobilization after their 3rd mobilization.

结局指标

主要结局

Postoperative Pain Score

时间窗: The child will be asked to rate the Wong-Baker FACES Pain Rating Scales 3 times: immediatelybefore mobilization, during mobilization and immediately after the mobilization.

Wong-Baker FACES Pain Rating Scale The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain. There are 6 faces in the Wong-Baker Pain Scale. The first face represents a pain score of 0, and indicates "no hurt". The second face represents a pain score of 2, and indicates "hurts a little bit". The third face represents a pain score of 4, and indicates "hurts a little more". The fourth face represents a pain score of 6, and indicates "hurts even more". The fifth face represents a pain score of 8, and indicates "hurts a whole lot"; the sixth face represents a pain score of 10, and indicates "hurts worst". This pain scale was originally developed for children.

次要结局

  • Mobilization Time(1st, 2nd and 3rd postoperative mobilization of the child. Each mobilization will take an average of 5-15 minutes.)

研究者

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

Huriye Karadede

Lecturer

Istanbul Aydın University

研究点 (2)

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