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临床试验/NCT06510166
NCT06510166已完成不适用

The Effect of Distraction Methods Used During Inhalation Therapy on Children's Fear and Anxiety: A Randomized Controlled Study

Ondokuz Mayıs University2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2024年4月8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
发起方
入组人数
120
试验地点
2
主要终点
changing the anxiety

研究概览

简要总结

It was aimed to examine the effects of distraction methods used during inhalation therapy on children's fear and anxiety.

Hypothesis:

Hypothesis 0 (H0): There is no difference between the fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques and toy type nebulizer + toy mask during inhaler treatment and the children in the control group.

Hypothesis 1 (H1): The fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques during inhaler treatment are lower than the children in the control group.

Hypothesis 2 (H2): The fear and anxiety levels of children who were applied a toy type nebulizer + toy mask during inhaler treatment are lower than the children in the control group.

Hypothesis 3 (H3): The fear and anxiety levels of children who were treated with a toy type nebulizer + toy mask during inhaler treatment were lower than those of children who were treated with a normal nebulizer + mask + distraction techniques.

详细描述

In the literature, distraction techniques are generally used in invasive procedures. On the other hand, it is possible that studies on the effects of inhalation therapy and non-pharmacological methods, which are among the common non-invasive interventions in children, can still continue. Durak et al. (2021) stated that the developments in experimental groups, in which they were made to watch cartoons during inhalation treatment, were lower in adults than in control groups and in children. A similar study was published by Ozsamuri (2020), and children receiving mask and inhaler treatment consisted of watching cartoons, listening to music, and a control group. As a result of the study, intra-group comparisons show that the fear and anxiety scores of people in cartoon and music groups decreased compared to before the procedure . However, arranging emergency services for children and selling them with treatment materials have been shown to be effective in reducing children's fears. Negative reactions to the growth mask and nebulizer during inhaler therapy, causing incorrect inhalation patterns, and deterioration are reduced. Yanık and Ayyıldız (2019) conducted a study on the effectiveness of the training given with a toy-type nebulizer for children aged 3-6 years who received nebulizer therapy. During the therapy inhaler treatment, the scores of the people in the experimental group decreased, while the scores of the control group increased. Kırkan (2023) stated that the therapeutic play method applied with toy nebulizers and toy nebulizers in the activities he conducted with 3-8 year old children who received nebulizers is an effective method treatment in reducing fear and anxiety in the children's hospital. Distracting methods during inhaler treatment for children are beneficial for patients to have positive hospital experiences. This will reduce patients' fear of the hospital, prevent providers from experiencing stress, and ensure that people are satisfied. Adequate information during treatment procedures in children will improve fear, pain and anxiety management and increase the positive hospital experience. Rapid healing is important because of the reduced use of treatment materials, the effectiveness of human resources, and the increase in health knowledge.

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

  • Parent and child volunteer to participate in the study,
  • The child is between 3-6 years old,
  • Presentation due to upper and lower respiratory tract infection,
  • Inhaler treatment will be applied with a nebulizer,
  • No request for any other intravenous, intramuscular or invasive treatment,
  • The child does not have any genetic, congenital, chronic or metabolic disease,

排除标准

  • Parent and child are not willing to participate in the study,
  • The child is not between 3-6 years old,
  • Presentation for a reason other than upper and lower respiratory tract infection,
  • No inhaler treatment with a nebulizer,
  • Request for any other intravenous, intramuscular or invasive treatment,
  • The child has any genetic, congenital, chronic or metabolic disease

研究组 & 干预措施

normal nebulizer + mask + distraction technique

Experimental

Inclusion criteria is below:

  1. Parent and child volunteer to participate in the study,
  2. The child is between 3-6 years old,
  3. Presentation due to upper and lower respiratory tract infection,
  4. Inhaler treatment will be applied with a nebulizer,
  5. No request for any other intravenous, intramuscular or invasive treatment,
  6. The child does not have any genetic, congenital, chronic or metabolic disease

干预措施: Children's Fear and Anxiety normal nebulizer and mask+ distraction (Behavioral)

toy type nebulizer + toy mask

Active Comparator

Inclusion criteria is below:

  1. Parent and child volunteer to participate in the study,
  2. The child is between 3-6 years old,
  3. Presentation due to upper and lower respiratory tract infection,
  4. Inhaler treatment will be applied with a nebulizer,
  5. No request for any other intravenous, intramuscular or invasive treatment,
  6. The child does not have any genetic, congenital, chronic or metabolic disease

干预措施: Children's Fear and Anxiety a toy nebulizer and a toy mask (Behavioral)

control group

No Intervention

Inclusion criteria is below:

  1. Parent and child volunteer to participate in the study,
  2. The child is between 3-6 years old,
  3. Presentation due to upper and lower respiratory tract infection,
  4. Inhaler treatment will be applied with a nebulizer,
  5. No request for any other intravenous, intramuscular or invasive treatment,
  6. The child does not have any genetic, congenital, chronic or metabolic disease

结局指标

主要结局

changing the anxiety

时间窗: 'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'

Children's Anxiety Meter- State (CAM-S) is designed like a thermometer, featuring a bulb at its base and horizontal markers at regular intervals as it ascends. Children are asked to represent their feelings on this scale by marking where they stand "right now". They are instructed, "Imagine that all your anxious or angry feelings are on the bulb or bottom part of the thermometer. If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are." This scale provides scores ranging from 0 to 10. As the score increases, the level of anxiety increases.

changing the fear

时间窗: 'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'

Children's Anxiety Meter- State (CAM-S) is designed like a thermometer, featuring a bulb at its base and horizontal markers at regular intervals as it ascends. Children are asked to represent their feelings on this scale by marking where they stand "right now". They are instructed, "Imagine that all your anxious or angry feelings are on the bulb or bottom part of the thermometer. If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are." This scale provides scores ranging from 0 to 10. As the score increases, the level of anxiety increases.

次要结局

未报告次要终点

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Koyun

Principal Investigator

Ondokuz Mayıs University

研究点 (2)

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