跳至主要内容
临床试验/NCT06262984
NCT06262984已完成不适用

The Effect of the Therapeutic Play Applied Before Nasopharyngeal Swaping on Children's Emotional Manifestation in the 3-6 Years Old Group

Maltepe University2 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2024年2月19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
入组人数
68
试验地点
2
主要终点
Children's emotional manifestation

研究概览

简要总结

The study will be conducted with the randomized controlled experimental method. Children who apply to the Child Health and Diseases Polyclinic and Child Health and Diseases Service and who will have nasopharyngeal swab applied will be divided into two groups by drawing lots. After the randomization children in the therapeutic play group the nasal swab will be shown on the doll to the child by the researcher before being taken. The child is then allowed to play with the doll accompanied by the researcher. No intervention will be performed on children in the control group. The parents will also be found next to their children in both groups during the procedure.

详细描述

Many different non-pharmacological methods are used to cope with negative emotional responses such as pain, stress, fear and anxiety caused by diagnostic procedures in children. One of these non-pharmacological methods is therapeutic play. Therapeutic play method applied in line with the philosophy of atraumatic care in preparation for medical diagnostic procedures can ensure children's adaptation to the procedures by reducing the negative emotional effects of these procedures on the child. Energy Expenditure Play, Dramatic Play and Creative Play are used as therapeutic play types.

The aim of this study is to determine the effect of therapeutic play applied before the nasopharyngeal swab procedure on the emotional indicators of children aged 3-6 years who apply to the pediatric clinic and pediatric service. In line with the results obtained from studies using a similar research method, the sample size of the study was determined by power analysis (G*Power 3.1.9.4). The sample size was found to be 68 children in total, with a minimum of 34 children for each group. To collect data, an information form and the Children's Emotional Manifestation Scale (CEMS) will be used. Children and their parents who apply to the pediatric service and pediatric outpatient clinic will be informed about the study. The children and parents included in the study will be informed about the research by the researcher through a face-to-face meeting, and a consent form and information form will be filled out. Children will determine their groups by drawing lots. The researcher will demonstrate the nasopharyngeal swabbing process on the doll with the children who have chosen a therapeutic play group, using a therapeutic play method, and play with the child. Children who choose the control group will be explained the nasopharyngeal swab procedure as routinely performed in the outpatient clinic. The Children's Emotional Manifestation Scale (CEMS) will be evaluated and scored by the researcher and the observing nurse.

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
None

入排标准

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

入选标准

  • Being between the ages of 3 and 6,
  • Children who have not received medical attention in the last 24 hours,
  • Children without speech, hearing, psychological or neurological problems,
  • Children who can speak and understand Turkish at native level,
  • Children and their parents who agree to participate in the research.

排除标准

  • Being younger than 3 years old and older than 6 years old,
  • Children who received medical intervention in the last 24 hours,
  • Children with any speech, hearing, psychological or neurological problems,
  • Children who do not speak Turkish as their native language,
  • Children and their parents who do not agree to participate in the research.

研究组 & 干预措施

Control Group

No Intervention

Children who choose the control group will be explained the nasopharyngeal swab procedure as routinely performed in the outpatient clinic.The Children's Emotional Manifestation Scale (CEMS) will be evaluated and scored by the researcher and the observing nurse.

Therapeutic Play Group

Experimental

The researcher will demonstrate the nasopharyngeal swabbing process on the doll with the children who have chosen a therapeutic play group, using a therapeutic play method, and play with the child. The Children's Emotional Manifestation Scale (CEMS) will be evaluated and scored by the researcher and the observing nurse.

干预措施: Therapeutic Play (Other)

结局指标

主要结局

Children's emotional manifestation

时间窗: one minute before nasopharyngeal swabbing, when nasopharyngeal swabbing begins, one minute after nasopharyngeal swabbing

The child's emotional response will be evaluated with the Children's Emotional Manifestation Scale (CEMS) by the researcher and the observing nurse before, during and after the procedure. In the scale, emotional indicators are evaluated according to 5 parameters (facial expression, voice, activity, interaction, cooperation level). These five parameters are scored from 1 to 5, with the lowest score being '5' and the highest being '25'. A higher scale score indicates that the child showed more negative emotional behavior during the procedure.

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

Zeynep Erkut

Assist. Prof.

Maltepe University

研究点 (2)

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