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

Not Applicable

Not yet recruiting

• Conditions: Inhalation Therapy

• Registration Number: NCT07073625
• Lead Sponsor: Ataturk University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Study Start: 2025-08-01
• Primary Completion: 2025-11-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Demographic Information Form	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.
Child anxiety Scale-State	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.
Child Fear Scale	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.

Trial Locations

Locations (1)

Erzurum City Hospital; 🇹🇷 Erzurum, Center, Turkey