NCT06090175

Brief Summary

This research was planned as a randomized controlled experimental type to determine the effect of using a projector caleidoscope and matching card on children's fear and physiological parameters in 3-6-year-old children who were administered inhaler medication. According to the power analysis performed for the sample size, the power of the sample was calculated with the G\*Power 3.1 program in line with the literature. While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. The data of the research will be collected using the following data collection tools; Child Information Form and Fear Rating Scale

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2023

Completed
Last Updated

November 27, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

October 12, 2023

Last Update Submit

November 23, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Child Information Form

    The information form was prepared by scanning the literature on the subject and has 12 questions including the child's age, gender, complaint, parent age (who was with him/her during the application) and educational status, physiological parameters before and after inhaler application.

    1 day

  • Children's Fear Scale

    It is used to evaluate the anxiety/fear level of children. The scale uses cartoon faces consisting of five pictures and the anxiety/fear level is evaluated with numbers between "0" and "4". The first picture shows a score of "0", that is, "no anxiety/fear is felt", and the last picture shows a score of "4", that is, "the most severe anxiety/fear". As the score increases, the level of anxiety/fear also increases.

    1 day

Study Arms (3)

projector colleyscope group

EXPERIMENTAL

Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. Before starting the procedure, the child will be introduced to the projector colleidoscope. Before the procedure, this device, which looks like a toy, will be projected onto the wall to divert attention. The projection will continue throughout the inhaler medication administration process. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.

Other: Projector colleyscope group

Matching card group

EXPERIMENTAL

Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. The child will be allowed to play with the matching cards 2-3 minutes before starting the drug treatment and will then be encouraged to play throughout the procedure. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.

Other: Matching card group

Control group

NO INTERVENTION

Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. Nothing will be shown to the child during the application. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, the Child Fear Scale will be evaluated by the researcher and the parent and recorded by the researcher in the intervention follow-up form.

Interventions

Projector kaleidoscope will be used in children aged 3-6 who are administered inhaler medication.

projector colleyscope group

Matching card will be used in children aged 3-6 who are administered inhaler medication.

Matching card group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • The child is between 3-6 years old,
  • No communication problems (visual/auditory/mental),
  • Oxygen saturation is 90% or above,
  • The child does not have a disease that may affect his/her life,
  • Parent and child volunteering to participate in the research.

You may not qualify if:

  • Nebul drug administration
  • The child has a visual, hearing or mental disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus State Hospital

Mersin, Turkey (Türkiye)

Location

Related Publications (8)

  • Conk, Z. Başbakkal, Z. Yılmaz, H. Bolışık, B. (2013). Pediatri Hemşireliği, Ankara:Akademisyen Tıp Kitabevi.

    BACKGROUND
  • Durak, H. (2019). Çocuklarda İnhaler İlaç Uygulaması Sırasında Çizgi Film İzletme Ve Oyun Kartı Kullanımının Fizyolojik Parametreler ve Korku Düzeyine Etkisi.(Yüksek Lisans Tezi),(645415).

    BACKGROUND
  • Erdinç, E. (2022). Evde Nebülizatör Tedavisi Kime? Nasıl?. Toraks Dergisi, 3(2), 21-25. Retrieved from https://turkthoracj.org/content/files/sayilar/93/buyuk/pdf_Toraksder_197.pdf

    BACKGROUND
  • İnal, S. & Canbulat, N. (2015). Çocuklarda İşlemsel Ağrı Yönetiminde Dikkati Başka Yöne Çekme Yöntemlerinin Kullanımı . Güncel Pediatri , 13 (2) , 116-121

    BACKGROUND
  • Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20.

    PMID: 19230769BACKGROUND
  • Taşdemir Akkavak, D. & Sarıkaya Karabudak, S. (2019). Hastanede Yatan Okul Çağı Çocukların Hemşireyi ve Hastaneyi Algılama Durumlarının İncelenmesi . Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi , 12 (1) , 46-56

    BACKGROUND
  • Türk Düdükcü, F. & Taş Arslan, F. (2016). Çocuklarda Nebülizatör İle İlaç Uygulama; Problemler Ve Çözüm Önerileri . Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi , 5 (4) , 71-77 .

    BACKGROUND
  • Özsamuri, G. (2020) Maske İle İnhaler İlaç Uygulanan 3-6 Yaş Grubu Çocuklarda Müzik Dinletme Ve Çizgi Film İzletmenin Hissedilen Korku, Anksiyete ve Fizyolojik Parametrelere Etkisinin Belirlenmesi.

    BACKGROUND

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Burcu Korkmaz

    Tarsus University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 19, 2023

Study Start

October 1, 2023

Primary Completion

November 23, 2023

Study Completion

November 23, 2023

Last Updated

November 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations