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NCT Number: NCT06823869

The Effect of Distraction Methods on Children Aged 3-6 Years Receiving Inhaler Therapy

The aim of this study is to observe the effect of distraction methods on children aged 3-6 years who apply to the emergency department due to respiratory complaints and receive inhaler medication.

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The research was designed based on voluntary participation in threegroups: the experimental group (doll and musical keyboard or musical book) and the control group. The inhaler drug application process is planned to be 10 minutes.

First, routine explanations are given to the children in the experimental group, and the child is ensured to be in an upright position for the parent to be present and to administer the inhaler medication. The child is explained that a doll will accompany him during the inhaler medication administration, and a nebulization mask is attached to the doll. Before starting the inhaler medication administration, the doll is placed next to the child in a sitting position. The child is asked to sit with the doll for 5 minutes and the child is asked whether he/she will play with a musical book or a musical piano.After the child decides which toy he/she will play with and plays with the toy for 5 minutes, the Child Fear Scale (CCS) and the Children's Emotional Indicators Scale (ÇEGÖ) are evaluated by the child, parent, researcher, nurse and vital signs before starting the procedure. Later, when the researcher decides that the child is ready for the procedure, inhaler medication administration is started. After the drug administration is completed, the child, parent, researcher and nurse evaluate the CQS and CEGRS, and vital signs are evaluated by the researcher, and the parent gives a parental satisfaction score.

In the control group, a routine explanation of the emergency department is given to the child and the parent, the parent is next to the child and the child is ensured to sit upright during the inhaler medication administration. To the children in the control group, the researcher shows how the procedure will be done with a nebula mask on himself. The procedure begins after the necessary explanations are made and the researcher decides that the child is ready for inhaler medication administration. Before starting the procedure, the child, parent, researcher, nurse and vital signs are evaluated by the researcher. After the inhaler intake is completed, ÇÖS and ÇEGÖ child, researcher, nurse, parent; Vital signs are evaluated by the researcher and parental satisfaction score is given by the parent.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • people who volunteer
  • Children between 3 and 6 years old
  • children without mental problems Children presenting to the emergency department with respiratory illnesses

Exclusion criteria

  • children with a mental problem
  • non-volunteers

Treatment and study plan

musical book

Other

The child will indicate that he wants to play with the musical book. The child will play with toys for 5 minutes before treatment. Once the child is ready, inhaler medication will begin and the treatment will last 10 minutes. The treatment is terminated at the end of the 10th minute. The child's playing time with the toy is approximately 15 minutes.

musical piano

Other

The child will indicate that he wants to play with the musical piano. The child will play with toys for 5 minutes before treatment. Once the child is ready, inhaler medication will begin and the treatment will last 10 minutes. The treatment is terminated at the end of the 10th minute. The child's playing time with the toy is approximately 15 minutes.

SHAM

Other

The child will not play with toys during treatment. Before the treatment, the researcher demonstrates the process on himself with a nebul mask. Treatment begins after the child is ready. The process will take 10 minutes.

Primary outcomes

  1. child fear scale

    Time frame: 5 minutes before the intervention, during the process and just after the intervention was completed. 20 minutes in total.

    Child Fear Scale:It is used to measure the child's anxiety level. It ranges from neutral expression (0=no anxiety).

    A scale ranging from 0 to 4, consisting of five drawn facial expressions ranging from a scared face (4=severe anxiety).

    is the scale

  2. Emotional Indicators Scale in Children

    Time frame: 5 minutes before the intervention, during the process and just after the intervention was completed. 20 minutes in total.

    It was developed by Ho Cheung, William Li and Violeta Lopez in 2005. In the scale, emotional indicators are evaluated according to 5 parameters. These parameters; facial expression, voice, activity, interaction and cooperation level. These five parameters are from 1 to 5.

    The lowest score in total is "5" and the highest score is "25".

Study contacts

Contact information is provided by the study sponsor or research team.

Associate Professor Esra Tural Büyük

CONTACT

[email protected]

+90(505)2795196

Berna Sözen

CONTACT

[email protected]

+90(535)8780200

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

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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