The Effect of Animated Videos and Therapeutic Play Methods on Emotional Expression, Fear and Anxiety in Children Aged 4-8 Years During the Throat Swab Procedure: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Changes in children's scores on scales measuring anxiety, fear and emotional expression before and after the intervention
研究概览
简要总结
We planned a study to determine the effect of showing an animated video and using educational therapeutic play methods prior to throat swab procedures in children aged 4-8 years on the children's compliance with the procedure, as well as on their emotional expression, fear and anxiety levels, and to compare the superiority/effectiveness of these two methods against one another. The sample size for the study was determined using an a priori power analysis conducted with the G*Power (v3.1.9.7) programme. It is planned to include a total of 105 children, with at least 35 children in each group. The study will be conducted using a single-blind, parallel-group, three-group experimental design. By demonstrating the effects of two different modern approaches on children's compliance, fear, anxiety and emotional responses during the throat swab procedure, this study will contribute to the development of evidence-based, atraumatic care practices in paediatric clinics.
详细描述
Hospital visits during childhood and the diagnostic and medical procedures carried out during these visits cause high levels of fear, anxiety and stress in children. The throat swab procedure, frequently used in the differential diagnosis of upper respiratory tract infections, is perceived by children as a threatening and invasive procedure due to the physical contact with the pharynx and the triggering of the gag reflex (Sajeev et al., 2021). Children aged 4-8, due to their developmental characteristics, may struggle to comprehend abstract concepts and may therefore interpret such procedures as punishment or an attack on their bodily integrity (Vakili et al., 2025). The intense anxiety and fear experienced during the procedure make it difficult for children to comply with treatment, leading to negative emotional expressions such as crying and resistance, and undermining the future healthcare professional-patient relationship (Şengül & Erkut, 2025).
In paediatric nursing and the philosophy of atraumatic care, minimising the psychological and physiological trauma children experience as a result of medical procedures is one of the primary objectives. The literature indicates that audiovisual distraction techniques using animated videos to reduce children's anxiety and fears, and instructional therapeutic play-which helps children learn by making the steps of a process tangible-are effective non-pharmacological methods (Suleiman-Martos et al., 2022; Altay et al., 2025). However, there are few randomised controlled trials directly comparing the effectiveness of the 'instructional animation video' method with that of 'therapeutic play'-which enables the child to experience the process and gain a sense of control-in a procedure such as a throat swab, which is sudden and highly uncomfortable.
This study will contribute to the development of evidence-based, atraumatic care practices in paediatric clinics by demonstrating the effect of two different modern approaches on children's compliance, fear, anxiety and emotional responses during the throat swab procedure.
Research Hypotheses:
H0: There is no difference in the levels of emotional expression, fear and anxiety among children who undergo the throat swab procedure following the use of animated videos and therapeutic play methods.
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)
盲法说明
Due to the nature of the research, it is not possible to blind the researcher and the participants. Blinding will only be applied during the analysis of the research data.
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children whose parents have provided written informed consent, who have had a throat swab taken at a paediatric clinic, who have verbally agreed to participate in the study, aged between 4 and 8 years, with no cognitive or neurological differences, with no visual or hearing impairment.
排除标准
- •Children whose parents have not provided written informed consent, who have not had a throat swab taken at a paediatric clinic, who have not verbally agreed to participate in the study, younger than 4 years or older than 8 years, with cognitive or neurological differences, with visual or hearing impairment.
研究组 & 干预措施
Animation video
In this group, the children will be shown a video explaining the throat swab procedure
干预措施: Animation video (Other)
therapeutic play
In this group, the procedure will be explained to the children through therapeutic play incorporating gamification elements, during which they will undergo a throat swab test.
干预措施: Therapeutic Play (Other)
control group
In this group, throat swab tests will be carried out on children in the usual manner.
结局指标
主要结局
Changes in children's scores on scales measuring anxiety, fear and emotional expression before and after the intervention
时间窗: Before İntervention and after procedure(throat swab)
Following the children's scores on the pre-intervention scales measuring anxiety, fear and emotional expression, the intervention will be carried out, followed by a throat swab. A second assessment will be conducted post-intervention to examine differences between the groups in changes to their scores on the scales.
次要结局
未报告次要终点
研究者
SÜMEYYE KAYA KOCAGİL
Resarch Assistant
Mersin University