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临床试验/NCT07371026
NCT07371026尚未招募不适用

The Effect of Using Distractor Cards and Thermochromic Cards on Pain, Fear, Anxiety and Procedure Time in Children Receiving Inhaler Therapy

Muhammed Ata Nur GEÇER0 个研究点目标入组 90 人开始时间: 2026年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
主要终点
Fear level before, during, and after inhalation therapy assessed by the Child Fear Scale (ÇKÖ)

研究概览

简要总结

THE EFFECT OF USİNG DİSTRACTOR CARDS AND THERMOCHROMİC CARDS ON PAİN, FEAR, ANXİETY AND PROCEDURE TİME İN CHİLDREN RECEİVİNG INHALER THERAPY.

Respiratory illnesses in children are a leading cause of childhood morbidity and mortality worldwide. Organizations such as the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) report that millions of children are hospitalized each year due to respiratory illnesses (He, Wang, & Zhang, 2025). A large proportion of these illnesses are caused by viral agents, and pathogens such as Respiratory Syncytial Virus (RSV), influenza, and rhinoviruses pose serious health threats to young children (Chen, Zhang, & Li, 2024).

This study will be one of the rare studies in pediatric nursing that examines the effectiveness of non-pharmacological interventions that can be applied during inhaler therapy in young age groups. The findings will contribute to nurses developing effective methods to reduce the negative emotions experienced by children during treatment. Furthermore, the first-ever use of thermochromic cards in this context in pediatric nursing will provide an innovative perspective on pediatric nursing practices.

H0: Thermochromic cards and distraction cards used during inhaler therapy have no effect on pain, fear, anxiety levels, or processing time.

Thermochromic cards used during inhaler therapy:

H1: reduce the child's pain. H2: reduce the child's fear. H3: reduce the child's anxiety level.

H4: shorten the child's processing time. Distraction cards used during inhaler therapy:

H5: reduce the child's pain. H6: reduce the child's fear. H7: reduce the child's anxiety level. H8: shorten the child's processing time.

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
Double (Participant, Care Provider)

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

  • The child must be between 4-6 years old,
  • The child must be receiving inhaler treatment,
  • The child must not have received IV or IM intervention before inhaler treatment,
  • The child's oxygen saturation must be 95% or higher,
  • The child's cognitive level and motor development must be appropriate for their age,
  • The child and parents must be willing to participate in the study,
  • The child and parents must be able to speak Turkish.

排除标准

  • The child must have a cognitive or mental problem,
  • The child must have special needs in terms of hearing, vision and/or speech,
  • The child must have a life-threatening condition,
  • The child's oxygen saturation level must be below 95%,
  • The child must not be routinely receiving inhaler treatment

研究组 & 干预措施

thermochromic card

Experimental

The thermochromic card aims to distract the child's attention.

干预措施: thermochromic card (Other)

distraction card

Experimental

The distraction card aims to divert the child's attention to something else.

干预措施: distraction card (Other)

clinic's routine inhaler treatment group

No Intervention

the group in which routine inhaler therapy is applied and no additional intervention is required

结局指标

主要结局

Fear level before, during, and after inhalation therapy assessed by the Child Fear Scale (ÇKÖ)

时间窗: Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy

Fear level will be assessed using the Child Fear Scale (ÇKÖ), a self-report scale consisting of six facial expressions and scored from 0 to 10 in increments of two points. Higher scores indicate greater levels of fear.

Pain intensity before, during, and after inhalation therapy assessed by the Wong-Baker FACES Pain Rating Scale

时间窗: Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy

Pain intensity will be measured using the Wong-Baker FACES Pain Rating Scale, which consists of six facial expressions scored from 0 to 10, where higher scores represent greater pain intensity.

Anxiety level before, during, and after inhalation therapy assessed by the Child Anxiety Scale-State (ÇAS-D)

时间窗: Before inhalation therapy, during the procedure, and up to 5 minutes after completion of inhalation therapy

Anxiety level will be assessed using the Child Anxiety Scale-State (ÇAS-D), a thermometer-shaped self-report scale developed for children aged 4-10 years. Higher marked levels indicate higher state anxiety.

次要结局

  • Duration of inhalation therapy(During inhalation therapy)

研究者

发起方
Muhammed Ata Nur GEÇER
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Muhammed Ata Nur GEÇER

MSc

Istanbul University - Cerrahpasa

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