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Completed

NCT Number: NCT06510166

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

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.

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University

Samsun, Atakum, 55139, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,

Exclusion criteria

  • 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

Treatment and study plan

Children's Fear and Anxiety normal nebulizer and mask+ distraction

Behavioral

Children in group 2 will receive their inhaler treatment with a normal nebulizer and mask, while at the same time one of the distraction techniques of their choice (drawing a picture, reading a story or watching an age-appropriate cartoon) will be applied.

Children's Fear and Anxiety a toy nebulizer and a toy mask

Behavioral

Children in Group 3 will receive their inhaler treatment using a toy nebulizer and a toy mask.

Primary outcomes

  1. changing the anxiety

    Time frame: '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.

  2. changing the fear

    Time frame: '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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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