跳至主要内容
临床试验/NCT07052955
NCT07052955招募中不适用

The Effect of Health Riddles on Fear, Anxiety, and Pain in Circumcised Children

Gümüşhane Universıty1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Introductory Information Form

研究概览

简要总结

This study was designed as a randomized controlled experimental method to examine the effects of health puzzles on the fear, anxiety and pain levels that occur in the pre- and postoperative periods in children who underwent circumcision.

详细描述

In the study, children aged 4-6 who came to be circumcised were divided into three groups: the Normal Circumcision Control Group, which received standard care and information, the Normal Riddle Group, which was supported by general fun riddles that did not contain health content, and the Health Riddles Group, which received an intervention that included health information and aimed to reduce children's fear and anxiety levels. The children's fear, anxiety and pain levels before and after the surgery will be measured using the Introductory Information Form, the Children's Fear Scale, the Children's Anxiety Scale-State and the Wong-Baker Facial Pain Scale as data collection tools.

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
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
Male
接受健康志愿者
否

入选标准

  • •Children who apply to Gümüşhane State Hospital Pediatric Surgery Department for circumcision
  • •Children between the ages of 4-6
  • •Not having had any previous surgical intervention
  • •Not having any problems with vision, hearing or speech
  • •Written consent given by a parent or legal guardian
  • •Not having health problems that could affect the research results, such as chronic disease or developmental delay
  • •The child and his/her family being open to communication and willing to cooperate during the study participation process

排除标准

  • •If the child or family does not want to continue the research
  • •If there is a sudden and serious deterioration in the child's health
  • •If participants do not comply with the research protocol, do not use the provided materials or do not participate in the measurements and do not continue
  • •If unexpected complications develop during the circumcision procedure
  • •If it is determined that the rights of the participants have been violated in accordance with ethical rules
  • •In these cases, the participant will be removed from the research and appropriate health care will be provided where necessary.

研究组 & 干预措施

Control Group

No Intervention

The control group will receive routine clinical care. No intervention will be made.

Experimental Group

Experimental

Before the circumcision, children will be shown a video animation show and will be made to play games with health riddles and normal riddle books.

干预措施: Health Riddles Group (Other)

Experimental Group

Experimental

Before the circumcision, children will be shown a video animation show and will be made to play games with health riddles and normal riddle books.

干预措施: The Normal Riddles Book (Other)

结局指标

主要结局

Introductory Information Form

时间窗: Baseline

The introductory information form prepared by the researchers consists of items related to the child's age, gender, height, weight, place of residence, number of siblings, previous hospitalization, previous surgery, mother's age, education status, father's age, education status and the family's economic status.

Child Fear Scale (CFS)

时间窗: Baseline and up to 4 weeks

This scale was developed by McMurtry and colleagues in 2011 and was adapted to Turkish by Gerçeker and his team in 2018 and validated. Designed for children between the ages of 5 and 10, this scale presents facial muscle changes in fearful expressions with a graphic artist's drawings based on photographs of frightened faces. The scale can be used by the family, child, or researcher to evaluate children. The scale shows the child a scale containing five facial expressions scored between 0 and 4. These expressions are interpreted as follows: 0: Neutral expression (no fear), 1: Very little fear, 2: Some fear, 3: More fear, 4: Highest level of fear. This scale can be used to measure the child's level of fear before and during the procedure.

Child Anxiety Scale-State (CAS-D)

时间窗: Baseline and up to 4 weeks

The "Child Anxiety Scale-State" (CAS-D) scale, developed by Ersig and his colleagues in 2013, is used to measure the situational anxiety of children between the ages of 4-10. Its validity was provided by Gerçeker and his team in 2018. CAS-D is designed in the shape of a thermometer and has a bulb chamber at the bottom and horizontal lines upwards. Each horizontal line represents one point, and there are 10 points in total. The bottom line represents a score of 0 and indicates a situation where there is no anxiety. The anxiety level increases as you go higher, and the top line represents the highest anxiety with a score of 10.

Wong Baker Pain Rating Scale

时间窗: Baseline and up to 4 weeks

The Wong-Baker Faces Pain Rating Scale is an adaptation of the Faces Rating Scale, a picture projection technique that uses 6 pictures of a child's facial expressions in pain to assess the child's level of pain. This scale is used to best describe the child's current level of pain. The child is asked to choose the face that best describes their pain. The descriptions of the faces are as follows: Face 0: Depicts a painless, happy face, meaning "I'm very happy, I'm in no pain." Face 5: Depicts a crying face, meaning "it hurts as much as you can imagine, but you don't have to cry to feel that bad." The responses on this 5-point scale range from 0 (very happy, no pain) to 5 (it hurts as much as you can imagine) and help determine the child's level of pain.

次要结局

未报告次要终点

研究者

发起方
Gümüşhane Universıty
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hatice Oğuzhan

Lecturer

Gümüşhane Universıty

研究点 (1)

Loading locations...

相似试验