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临床试验/NCT07348900
NCT07348900已完成不适用

The Effect of Nurse-Led Recreational Play Activities on Anxiety Levels of Children Undergoing Chemotherapy and Their Parents: A Quasi-Experimental Study

Akdeniz University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年11月15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
64
试验地点
1
主要终点
Change in Children's State Anxiety Scale Score

研究概览

简要总结

This single-group pretest-posttest study evaluated changes in anxiety levels among children undergoing inpatient chemotherapy and their parents following nurse-led recreational play activities. Thirty-one child-parent pairs completed the study. Child anxiety was assessed using the Children's State Anxiety Scale, and parent anxiety was assessed using the State Anxiety Inventory Form-I immediately before and immediately after the recreational play intervention.

详细描述

This study aimed to examine the effect of recreational play activities on anxiety levels of children undergoing chemotherapy and their parents. A quasi-experimental study design was used. The study was conducted in a pediatric oncology unit and included children receiving chemotherapy and their parents who met the inclusion criteria.

Participants were assigned to an intervention group that received structured recreational play activities in addition to routine care. Recreational play activities were planned according to the age and developmental level of the children and were implemented during chemotherapy sessions. The activities included age-appropriate games and play-based interactions designed to promote relaxation, emotional expression, and coping.

Anxiety levels of children and parents were assessed before and after the intervention using validated anxiety measurement scales. Demographic and clinical data were also collected. The primary outcome of the study was the change in anxiety levels of children and parents following participation in recreational play activities.

Ethical approval was obtained from the relevant Clinical Research Ethics Committee prior to the initiation of the study. Written informed consent was obtained from parents, and assent was obtained from children when appropriate. All study procedures were conducted in accordance with ethical principles and institutional guidelines.

The results of this study provide evidence on the effectiveness of recreational play activities as a non-pharmacological nursing intervention to reduce anxiety in pediatric oncology settings and support the integration of play-based approaches into routine clinical care.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 4-10 years who were hospitalized for chemotherapy treatment in the pediatric oncology and hematology clinic Willingness of both the child and parent to participate Written informed consent provided by the parent Parent able to read and write Turkish

排除标准

  • A major stressful life event unrelated to the illness during the previous six months, such as parental divorce, relocation, or death of a family member A clinically unstable condition preventing participation in recreational activities Terminal-stage disease

研究组 & 干预措施

Nurse-Led Recreational Play Intervention

Experimental

Children and their parents received structured play-based supportive care activities in addition to routine chemotherapy care.

干预措施: Nurse-Led Recreational Play Activities (Behavioral)

结局指标

主要结局

Change in Children's State Anxiety Scale Score

时间窗: Immediately before and immediately after the recreational play intervention, within the same session

The Children's State Anxiety Scale is a single-item visual scale used to assess children's state anxiety. Scores range from 0 to 10, with higher scores indicating greater state anxiety. Change was evaluated by comparing the scores obtained immediately before and immediately after the recreational play intervention.

Change in Anxiety Level in Children Undergoing Chemotherapy

时间窗: Baseline and immediately after the intervention during the chemotherapy session

Anxiety level of children was assessed using a validated anxiety scale before and after the play-based supportive care intervention during chemotherapy.

次要结局

  • Change in Parent State Anxiety Inventory Form-I Score(Immediately before and immediately after the recreational play intervention, within the same session)
  • Baseline and immediately after the intervention during the chemotherapy session(Baseline and immediately after the intervention during the chemotherapy session)
  • Change in Anxiety Level of Parents(Baseline and immediately after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sule ŞENOL

PhD

Akdeniz University

研究点 (1)

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