NCT06755918

Brief Summary

The clinical features of respiratory system diseases seen in childhood are generally moderate and improve in a short time. Respiratory system diseases are divided into two as upper respiratory system diseases and lower respiratory system diseases. The respiratory tract, from the mouth and nose, which are the upper respiratory tract, to the glottis (nasal mucosa, nasopharynx, oropharynx, sinuses, middle ear tonsils and epiglottis) and the infections that occur in these sections are called upper respiratory tract infections (URTI). Lower respiratory system diseases are considered as tuberculosis, asthma, cystic fibrosis and bronchopulmonary dysplasia. The most common diseases in children are respiratory tract diseases. The diseases that are considered as priorities for each age group vary. According to the Turkish Thoracic Society, the incidence of lower respiratory tract infections (LRTI) between the ages of 0-5 is 29%. According to TUIK 2022 data, upper respiratory tract infections are the most common infectious diseases experienced by children between the ages of 0-6 with a rate of 31.3%, and lower respiratory tract infections are the third with a rate of 6.9%. In children between the ages of 7-14, upper respiratory tract infections are the most common with a rate of 27.1%, and lower respiratory tract infections are the third with a rate of 5.3%.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 9, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

January 1, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 15, 2024

Last Update Submit

December 31, 2024

Conditions

Keywords

NebulizerChildAnxietyTreatment ComplianceNursing

Outcome Measures

Primary Outcomes (3)

  • Introductory Information Form

    It was created by the researcher in line with the literature in order to obtain the child's sociodemographic and disease information. The form contains nineteen questions including the child's age, gender, school attendance status, previous nebulizer use status and the reaction if the child has previous nebulizer use experience.

    The introductory information form will be filled out by the researcher during the first nebule treatment of the children's hospitalization. (Approximately 5 minute)

  • Child Anxiety Scale-State

    Child Anxiety Scale-State was developed by Ersıg and his colleagues in 2013 to measure the state anxiety of children between the ages of 4-10, and its validity and reliability in our country were determined by Ozalp Gerceker and his colleagues (2018). The child anxiety scale looks like a thermometer with 10 sections and is very easy to use. It indicates that anxiety increases as you go from bottom to top (0=calm, 10=very anxious). The child is asked to mark the sections on the scale that they feel 'right now'. In the literature research, it was seen that the scale was used between the ages of 7-12.

    After the nebulization process is completed, the child anxiety scale-state scale will be asked to be filled out by the child's parent and the child. (Approximately 10minute). Repeat measurements will be taken 24 hours after the first nebulizer treatment.

  • Treatment Adherence Questionnaire

    The form created by the researchers in line with the literature is a form created to measure children's compliance during treatment. It includes children's reactions and vital signs. This form will be sent to academicians and specialist nurses who are experts in the field of child health and disease nursing and will be presented for expert opinion. The form, which has been finalized and the expert opinion has been completed, will be applied to children during and after the procedure.

    The treatment compliance questionnaire developed by the researchers will be filled out by the researcher. (Approximately 5 minute) Repeat measurements will be taken 24 hours after the first nebulizer treatment.

Study Arms (3)

Control

ACTIVE COMPARATOR
Behavioral: Control

Video game group

EXPERIMENTAL
Behavioral: Video game

Mask painting group

EXPERIMENTAL
Behavioral: Mask painting

Interventions

ControlBEHAVIORAL

Children will be monitored when fowler is in position during the use of nebulizers. In the Fowler position, the drug will be drained into the nebulizer chamber. Mask and nebulizer connections will be completed. The patient will be told to breathe slowly and deeply. It will be examined whether sufficient steam is formed from the nebulizer device. The continuation of the application steps will be ensured until the nebulizer drug application is finished. Routine nursing care is applied during the use of nebulizer. During the use of a control group nebulizer, routine nebulizer will be used without video game and mask painting. After the receipt of the receipt, the child's anxiety scale-status scale will be requested to be filled by the child's parent and child. The treatment questionnaire developed by the researchers will be filled by the researcher. After 24 hours a day after the first nebulizer treatment of hospitalization, measurements will be made again.

Control
Video gameBEHAVIORAL

Children will be monitoring while the fowler position during the use of nebulizers. While the Fowler position is in the position of the drug, the drug will be drained into the nebulizer reservoir. The nebul mask will be attached to cover the mouth and nose. The patient will be told to breathe slowly and deeply. It will be examined whether sufficient steam is formed from the nebulizer device. The continuation of the application steps will be ensured until the nebulizer drug application is finished. At the same time, the Water-Sorting Game will be introduced while the use of nebul will be introduced and you will be asked to play. After the receipt of the receipt, the child's anxiety scale-status scale will be requested to be filled by the child's parent and child. The treatment questionnaire developed by the researchers will be filled by the researcher. After 24 hours a day after the first nebulizer treatment of hospitalization, measurements will be made again.

Video game group
Mask paintingBEHAVIORAL

While the Fowler position is in the position of the drug, the drug will be drained into the nebulizer reservoir. The nebul mask will be attached to cover the mouth and nose. The patient will be told to breathe slowly and deeply. It will be examined whether sufficient steam is formed from the nebulizer device. The continuation of the application steps will be ensured until the nebulizer drug application is finished. At the same time, mask painting process will be introduced while the use of nebul continues. For mask painting, six color paint will be given and the shapes and colors will be completely left to the child by leaving it to him. After the mask painting and receipt is finished, the child's anxiety scale-status scale will be requested to be filled by the child's parent and child. The treatment questionnaire developed by the researchers will be filled by the researcher. After 24 hours a day after the first nebulizer treatment of hospitalization, measurements will be made again.

Mask painting group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Between the ages of 7-12
  • Receiving the first nebulization treatment after hospitalization
  • Able to speak and read Turkish
  • Receiving nebulizer treatment
  • Children who agree to participate in the study and children whose parents agree to participate in the study

You may not qualify if:

  • Those who are allergic to paint
  • Those who have a chronic disease and routinely use a nebulizer
  • Those who are connected to any respiratory device (mechanical, etc.)
  • Those who did not complete the intervention and wish to withdraw from the study
  • Those who have any body function deficiency that prevents coloring or tablet games

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPatient Compliance

Condition Hierarchy (Ancestors)

Mental DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research is a randomized controlled experimental study.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor (PhD, RN)

Study Record Dates

First Submitted

December 15, 2024

First Posted

January 1, 2025

Study Start

December 9, 2024

Primary Completion

March 15, 2025

Study Completion

June 15, 2025

Last Updated

January 1, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations