Fear, Emotional Behaviors and Parental Care Satisfaction Related to Inhalation Therapy

NCT07442019 | Completed

• 1 other identifier: KMU-SBF-VAC-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aim to determine the effect of finger puppet, video game or stress ball methods on the fear levels, emotional behaviors and parental care satisfaction of children aged 4-6 years due to inhaler treatment.

Conditions

Child, Only; Fear; Pediatric Nursing; Emotions

Keywords

Child; Emotions; Pediatric Nursing; Fear

Outcome Measures

Primary Outcomes (3)

• child fear scale

  The scale can be used to determine the level of fear in children aged 4-10 years. It is administered by showing the child five facial expressions, ranging from a neutral expression ("0") to a frightened face ("4").

  The child was assessed 5 minutes before inhaler treatment. The child was assessed during inhaler treatment. The child was also assessed immediately after inhaler treatment was completed.

• children's emotional manifestation scale

  The scale can evaluate children's emotional indicators based on five parameters. These five parameters are: facial expression, vocal activity, interaction, and level of cooperation.

  The child was assessed 5 minutes before inhaler treatment. The child was assessed during inhaler treatment. The child was also assessed immediately after inhaler treatment was completed.

• PedsQL health care satisfaction scale

  The scale includes six main categories: information, family involvement, communication, technical skills, emotional needs, and overall satisfaction. The scale is evaluated based on the understanding that higher scores indicate higher satisfaction levels.

  Parents were asked to evaluate and record their satisfaction with the PedsQL Healthcare Satisfaction Scale immediately after the inhaler treatment was completed.

Study Arms (3)

Finger Puppet

EXPERIMENTAL

A "Finger Puppet Scenario Text" was prepared for use with children during inhaler treatment. The finger puppets used in the study were designed specifically for this research, being colorful and wearable on the finger for both boys and girls. This scenario text and the puppets were evaluated by experts. In the finger puppet application, the researcher introduced the finger puppets to the children before inhaler treatment. Then, the finger puppet scenario was implemented by the researcher. This stage lasted approximately 10 minutes. During inhaler treatment, as outlined in the finger puppet scenario text, the puppet remained silent and in a sleep mode (silent play) throughout the treatment, depending on the cooperation between the child and the puppet. The Child Fear Scale and the Emotional Indicators Scale were evaluated and recorded before, during, and after inhaler treatment. The PedsQL Healthcare Satisfaction Scale was evaluated at the end of inhaler treatment.

Other: Finger Puppet

Video Game

EXPERIMENTAL

The video game used in the study was selected from among the children's parent's mobile phones and chosen by the child themselves. Ten minutes before the start of inhaler treatment, the video game was introduced and explained, and the child was asked to start playing and continue playing the video game throughout the inhaler treatment. The video game playing time lasted approximately 10 minutes. During inhaler treatment, children in the video game group were allowed to play the video game. The mask remained on the child while playing the video game. The Child Fear Scale and Emotional Indicators Scale were evaluated and recorded before, during, and after inhaler treatment. The PedsQL Healthcare Satisfaction Scale was evaluated at the end of inhaler treatment.

Other: Video Game

Stress Ball

EXPERIMENTAL

In this study, a stress ball was chosen that was soft and sized appropriately for the child's hand. Children in the stress ball group were given a stress ball before the procedure and asked to squeeze it during the procedure. Ten minutes before the start of inhaler treatment, the child was given the stress ball, introduced to it, and asked to squeeze, release, and play with it. The Child Fear Scale and the Emotional Indicators Scale were evaluated and recorded before, during, and after inhaler treatment. The PedsQL Healthcare Satisfaction Scale was evaluated at the end of inhaler treatment.

Other: Stress Ball

Interventions

Finger Puppet OTHER

Finger Puppet

Finger Puppet

Video Game OTHER

Video Game

Video Game

Stress Ball OTHER

Stress Ball

Stress Ball

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• the child being between 4-6 years old,
• receiving inhaler treatment via mask,
• not having received inhaler treatment for the last 6 months,
• receiving bronchodilator medications as part of inhaler treatment,
• having no vision or speech problems,
• having no hearing problems,
• the child and parent being able to speak and understand Turkish fluently,
• being willing to participate in the study, and the families agreeing to participate in the research and signing the informed consent form.

You may not qualify if:

• the child receiving medications other than bronchodilators as part of inhaler treatment,
• the child and parent not being able to speak or understand Turkish fluently, and not being willing to participate in the study.

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

Study Sites (1)

Public Hospital

Karaman, 7000, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An observer independent of the study was blinded to the study hypothesis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD

Model Details: This study was conducted in a randomized, experimental research design.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 2, 2026
• Study Start: January 1, 2024
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)