The Effect of Two Different Interventions Applied During the Transfer of Children to the Operating Room for Circumcision on Fear, Anxiety, Comfort and Pain Levels: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Animal-assisted therapy intervention applied during transfer to the operating room changes Wong-Baker pain scale scores in the postoperative period.
研究概览
简要总结
The aim of this randomized controlled experimental study was to determine the effects of two different interventions on fear, anxiety, comfort, and pain levels during the transfer of children undergoing circumcision to the operating room.
The main questions it aims to answer are:
- H1: Animal-assisted intervention during transfer to the operating room affects children's fear.
- H2: Animal-assisted intervention during transfer to the operating room affects children's anxiety.
- H3: Animal-assisted intervention during transfer to the operating room affects children's comfort.
- H4: Animal-assisted intervention during transfer to the operating room affects children's pain.
- H5: Playing with a kaleidoscope during transfer to the operating room affects children's fear.
- H6: Playing with a kaleidoscope during transfer to the operating room affects children's anxiety.
- H7: Playing with a kaleidoscope during transfer to the operating room affects children's comfort.
- H8: Playing with a kaleidoscope during transfer to the operating room affects children's pain.
Researchers will investigate the effects of animal-assisted intervention and kaleidoscopes on anxiety, fear, pain, and comfort during the transfer to the operating room in boys aged 7-10 undergoing circumcision. A comparison will be made with a control group to determine this effectiveness.
Participants:
- The animal-assisted intervention group will initiate interaction with a goldfish in a portable aquarium during the preoperative period and accompany them until they arrive in the operating room.
- The kaleidoscope group will be distracted with a kaleidoscope during the preoperative period and continue this intervention until they arrive in the operating room.
- The control group will follow the hospital's routine patient transfer procedure.
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
- 7 Years 至 10 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •7-10 age group
- •Circumcision performed under general anesthesia or sedation
- •Pain level 0 before surgery
- •Child has literacy skills
- •Child and parent volunteer to participate in the study
排除标准
- •The child has had previous surgical experience
- •The child is allergic to fish products or fish meal
- •The child has a special condition that may cause difficulty understanding and perceiving
- •Any complications develop in the postoperative period
- •The child and parent wish to withdraw from the study
- •The child's hemodynamic instability
研究组 & 干预措施
Animal Assisted Practice Group
干预措施: Animal Assisted Practice (Behavioral)
Kaleidoscope Group
干预措施: Kaleidoscope (Behavioral)
Control Group
结局指标
主要结局
Animal-assisted therapy intervention applied during transfer to the operating room changes Wong-Baker pain scale scores in the postoperative period.
时间窗: up to the 1st postoperative hour
Wong-Baker Pain Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the pain level also increases.
Kaleidoscope intervention applied during transfer to the operating room changes Child Fear Scale scores in the preoperative period.
时间窗: 10 minutes before surgery
Child Fear Scale: The score that can be obtained from the scale varies between 0 and 4 points. As the score increases, the fear level also increases.
Animal-assisted therapy intervention applied during transfer to the operating room changes Child Fear Scale scores in the preoperative period.
时间窗: 10 minutes before surgery
Child Fear Scale: The score that can be obtained from the scale varies between 0 and 4 points. As the score increases, the fear level also increases.
Kaleidoscope intervention applied during transfer to the operating room changes Child Anxiety Scale scores in the preoperative period.
时间窗: 10 minutes before surgery
Child Anxiety Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the anxiety level also increases.
Kaleidoscope intervention applied during transfer to the operating room changes Wong-Baker pain scale scores in the postoperative period.
时间窗: up to the 1st postoperative hour
Wong-Baker Pain Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the pain level also increases.
Animal-assisted therapy intervention applied during transfer to the operating room changes Child Anxiety Scale scores in the preoperative period.
时间窗: 10 minutes before surgery
Child Anxiety Scale: The score that can be obtained from the scale varies between 0 and 10 points. As the score increases, the anxiety level also increases.
Animal-assisted therapy intervention applied during transfer to the operating room changes Comfort Behaviors Checklist scores in the postoperative period.
时间窗: up to the 1st postoperative hour
Comfort Behaviors Checklist: The score that can be obtained from the scale varies between 25 and 100 points. As the score increases, the comfort level also increases.
Kaleidoscope intervention applied during transfer to the operating room changes Comfort Behaviors Checklist scores in the postoperative period.
时间窗: up to the 1st postoperative hour
Comfort Behaviors Checklist: The score that can be obtained from the scale varies between 25 and 100 points. As the score increases, the comfort level also increases.
次要结局
未报告次要终点
研究者
MELİS CAN KESGİN GÜNGÖR
Principal Investigator
Kafkas University