The Effect of Using Nebula Bear on Anxiety and Fear During Nebulizer Application in Children

NCT06769802 | Active Not Recruiting DMC

• 1 other identifier: NEUYLTEZ2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Many respiratory system diseases are treated with inhalers. Providing inhaler treatment is provided by nebulizer devices. Taking the exact and effective dose of inhaler treatment affects the patient's recovery process. The use of nebulizer devices in children differs from that in adults. For children, the nebulizer may seem foreign and scary, which may cause them to reject inhaler treatment. Therefore, it is important to reduce anxiety and fear in children during nebulizer treatment. Since it is thought that the nebulizer bear, which is planned to be used in the study to reduce these negative situations caused by nebulizer treatment, may be effective in reducing anxiety and fear in children, it is thought that the study will have a positive physical and psychological contribution to children and parents.

Conditions

Children; Nebulizer Therapy

Keywords

Child; Nebulizer Therapy; Nebulizer; Nursing; Fear; Anxiety

Outcome Measures

Primary Outcomes (3)

• Parent and Child Information Form

  Parent and child information form was created by researchers according to the literature. In the form content; It contains information about introductory characteristics about the child and the family (age, mother's education level, number of children, medical diagnosis, previous hospitalization, previous use of nebule therapy) and consists of 9 questions.

  It will be filled out by the parent within the first 60 minutes of the child's hospitalization. (Approximately 5 minute.)

• Child Fear Scale

  This scale was used by McMurty et al.ild or the researcher to measure children's anxiety levels. It was developed by in 2011. The scale was developed by Gerçeker et al. in 2018. It has been validated in Turkish by and is aimed at children aged 4-10. Facial muscles changes in fearful expressions were drawn by a graphic designer based on photographs of frigtened faces. The scale can be used by the family, the child or the researcher to evaluate children. In this scale, the child is shown a scale containing five facial expressions rated between 0 and 4 points. While 0 indicates no fear and anxiety; 4 shows the highest fear and anxiety. These are: "0" neutral expression (no anxiety), "1" very little fear (very little anxiety), "2" some fear (some anxiety), "3" more fear (more anxiety), "4" the most fear possible. It is considered high fear (severe anxiety).

  It will be filled out by the researcher and parent 5 minutes before the procedure and 5 minutes after the procedure (Approximately 10 minute).

• Children's Anxiety Meter-State (CAM-S)

  Children's Anxiety Meter-State was developed by Ersig et al. in 2013. A scale is a scale similar to a thermometer with horizontal lines. It is aimed at children aged 4-10 and was developed to measure children's anxiety. Teach kids: "Imagine all your anxious feelings are at the bottom." When instructed" If anxious feelings are high, paint the thermometer upwards with a pencil.Before filling out the scale, the child's number ordering level should be evaluated. Children who do not understand these instructions are not allowed to fill out the scale. After the child makes a rating on the scale, a transparent meter is placed on the scale and the marked point is measured.Half-point increments are rounded to the nearest number. The scale score is between 0-10.

  It will be filled out by the child 5 minutes before the procedure and 5 minutes after the procedure (Approximately 5 minute).

Study Arms (2)

Experimental: Nebula Bear Group

EXPERIMENTAL

Behavioral: Experimental

Active Comparator: Control

ACTIVE COMPARATOR

Behavioral: Control

Interventions

Experimental BEHAVIORAL

The children in this group and their mothers will be informed about the research and their written consent will be obtained. The scale will be filled in before the application. Before the application, Nebul will introduce the teddy bear to the mother and child. The teddy bear cannot be washed because it contains an electronic device. Therefore, it will be disinfected with a solution containing 60-70% alcohol before and after use. The recorded voice will then be played to the child and mother. Then, routine nebulizer treatment will be applied and the second audio recording will be played at the end of the treatment. The researcher will be with the child. At the end of the nebulizer treatment, after the mask is removed, the Child Fear Scale and the Child Anxiety Scale-State Scale will be filled out. The Child Fear Scale will be filled in by both the mother and the nurse and the average will be taken.

Also known as: Nebula Bear Group

Experimental: Nebula Bear Group

Control BEHAVIORAL

The children in this group and their parents will be informed about the research and their written consent will be obtained. Scales will be filled in before application. Children in this group will receive routine nebulizer treatment and routine application will be performed. At the end of the treatment, the scales will be filled in again.

Active Comparator: Control

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Are between the ages of 4-6, Parent's ability to read and write Turkish, Accompanied by their parents, Children who are willing to participate in the research will be included in the research, They receive the first nebule treatment of their hospitalization.

You may not qualify if:

• Have mental disabilities or communication problems, Visual or hearing impairment, Those who have any body function deficiency Children who routinely use nebulizers

Sponsors & Collaborators

• Havva Nur Özlenir: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master Student/Nurse

Model Details: The study was planned as a pre-test, post-test parallel group (invertion-control), randomized controlled experimental research type.

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 10, 2025
• Study Start: December 28, 2024
• Primary Completion: March 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)