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NCT Number: NCT07073625

During Inhaler Application, Children Were Given Stress Ball and Storybook Reading Interventions

It aims to examine the effects of stress ball and book reading methods on children's fear and anxiety levels during inhalation.

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Key information

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erzurum City Hospital

Erzurum, Center, 25000, Turkey (Türkiye)

Location contact

Zülbiye DEMİR BARBAK, LECTURER

CONTACT

[email protected]

05435164229

About this study

Ninety-nine volunteer children aged 5-6 who will receive inhalation therapy will be randomly assigned to three groups: stress ball, storybook reading, and control. Children will be assessed before, during, and after the procedure. Inhalation-related fear will be assessed using the Children's Fear Scale, and anxiety will be assessed using the Children's State Anxiety Scale. Furthermore, children's demographic data will be recorded on the Information Form.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • No audiovisual impairment,
  • Being open to communication and
  • Must be accompanied by a parent.

Exclusion criteria

  • Having special needs,
  • Having an audio-visual impairment,
  • Learning difficulties or mental retardation and
  • Children whose parents do not agree to participate in the study.

Treatment and study plan

Stress ball

Other

Children arriving at the hospital's emergency department and meeting the study criteria will be randomly assigned to the stress ball group. Before inhalation therapy, the child will begin squeezing the chosen stress ball. This will distract their attention, transforming the frightening hospital environment into a fun one. The questionnaires will be completed by the nurse and family five minutes before, during, and after the inhalation therapy.

Reading Storybook

Other

The storybook for the children will be selected by child psychologists. The book will be read to the children by their parents. The storybook reading will begin 15 minutes before the inhalation therapy and will be completed before the treatment begins. The storybook will be read to the children only once.

Primary outcomes

  1. Demographic Information Form

    Time frame: Baseline

    It is a form consisting of a total of 13 questions including the child's age, gender, diagnosis, duration of treatment, number of treatments (How many times did the child come to the clinic?), the status of receiving information about dental treatment and the person who received the information, the education level and occupation of the mother and father, the place where the family lives and the economic situation. It was prepared by the researchers in line with the literature.

  2. Child anxiety Scale-State

    Time frame: Baseline and up to 4 weeks

    "Child Anxiety Scale-State" scale developed by Ersig et al. in 2013 measures the state anxiety of children aged 4-10 years. In 2017, Gerceker et al. carried out Turkish validity study for the scale. CAS-S (State) is designed as a thermometer. At the bottom is the bulb chamber, and upward are horizontal lines. Each horizontal line represents a score, and the thermometer has 10 points. The bulb chamber at the bottom is 0 points and indicates that there is no anxiety. It is interpreted as the rise of anxiety as it rises upwards. The peak is worth 10 points and refers to the highest anxiety.

  3. Child Fear Scale

    Time frame: Baseline and up to 4 weeks

    This scale was developed by McMurtry et al. in 2011. In 2018, Gerceker et al. carried out a Turkish validity study for the scale. The scale is aimed at children aged 5-10 years. The facial muscle changes in fearful expressions are drawn by a graphic artist based on photos of frightened faces. In this scale, the child is shown a scale containing five facial expressions that are evaluated between 0 and 4 points. While 0 point refers to no fear; 4 points refers to the highest fear.

Study contacts

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

Sultan Esra SAYAR, Lecturer

CONTACT

[email protected]

+905302935474

Zülbiye DEMİR BARBAK, 1

CONTACT

[email protected]

+905435164229

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

The Effects of Stress Ball and Storybook Reading During Inhaler Application on Fear and Anxiety in Children

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 18, 2025
Registry last updated
Jul 18, 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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