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Completed

NCT Number: NCT05415566

The Effect of Therapeutic Play Applied by Using Toy Nebulizer and Toy Mask on Child's Fear and Anxiety Level

In this study, it was aimed to examine the effect of therapeutic play applied with a toy nebulizer and toy mask before inhaler treatment on children's fear and anxiety.

It is the hypothesis of the study that the therapeutic play applied by using a toy mask and a toy nebulizer before inhaler treatment in children will reduce the child's fear and anxiety.

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Key information

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Bornova, Turkey (Türkiye)

About this study

Acute diseases constitute the majority of applications made to pediatric emergency services. Inhaled drugs are frequently used in the treatment of childhood acute respiratory system diseases. Nebulizers are the preferred method of administering inhaled drugs. Medical procedures are one of the biggest fears of children, making it difficult to use nebulizers correctly and effectively. The negative reaction of the child to the mask and nebulizer during inhaler treatment causes incorrect inhalation patterns, reducing the safety and effectiveness of the treatment. This causes difficulties in relieving symptoms, increased hospital admission and hospitalization time, more treatment costs, and even negative consequences such as increased morbidity.

Reducing the fear and anxiety seen in children due to the hospital environment and illness is important in terms of children's acceptance of the treatment process. One of the methods used for this purpose is therapeutic play. Pediatric nurses should fulfill their nursing roles and responsibilities by including therapeutic play in their care processes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Parent and child volunteering to participate in the study,
  • The child is between the ages of 3-8,
  • Being admitted due to respiratory system disease,
  • Inhaler treatment with a nebulizer will be applied.

Exclusion criteria

  • Parent and child not voluntarily participating in the study,
  • Intravenous, intramuscular or any other treatment request,
  • The child has any genetic, congenital, chronic or metabolic disease,
  • The child has vision, hearing and speech problems,
  • The child's vital signs are unstable (no fever, tachypnea, etc.) and the need for any emergency intervention.

Treatment and study plan

toy nebulizer and toy mask

Combination Product

The treatment was administered using therapeutic play.

Primary outcomes

  1. Reducing the child's fear

    Time frame: during inhaler treatment

    Reducing the child's fear during inhaler treatment

  2. Reducing the child's anxiety

    Time frame: during inhaler treatment

    Reducing the child's anxiety during inhaler treatment

Secondary outcomes

  1. Reducing the "Child Fear Scale" score

    Time frame: shortly after inhaler treatment

    The Child Fear Scale (CFS) used. This one-item scale consists of five sex-neutral faces. It ranges from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. The rater responds indicates the level of fear. Scores range from 0 to 4.

  2. Reducing the "Child Anxiety Scale-Stateness" score

    Time frame: shortly after inhaler treatment

    The Children's Anxiety Meter (CAM) used. It assesses children's anxiety in clinical settings and uses before medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom, also includes horizontal lines at intervals going up to the top. Children are asked to mark how he/she feel "right now" to measure state anxiety. Scores range from 0 to 10.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 13, 2022
Registry last updated
Jun 14, 2022

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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