The Effect of Using Projector Kaleidoscope and Matching Card on Children's Fear and Physiological Parameters
1 other identifier
interventional
114
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
1 active site
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
October 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 12, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2023
CompletedNovember 27, 2023
October 1, 2023
2 months
October 12, 2023
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
EXPERIMENTALApproximately 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.
Matching card group
EXPERIMENTALApproximately 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.
Control group
NO INTERVENTIONApproximately 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.
Matching card will be used in children aged 3-6 who are administered inhaler medication.
Eligibility Criteria
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)
Related Publications (8)
Conk, Z. Başbakkal, Z. Yılmaz, H. Bolışık, B. (2013). Pediatri Hemşireliği, Ankara:Akademisyen Tıp Kitabevi.
BACKGROUNDDurak, H. (2019). Çocuklarda İnhaler İlaç Uygulaması Sırasında Çizgi Film İzletme Ve Oyun Kartı Kullanımının Fizyolojik Parametreler ve Korku Düzeyine Etkisi.(Yüksek Lisans Tezi),(645415).
BACKGROUNDErdinç, 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
BACKGROUNDİnal, S. & Canbulat, N. (2015). Çocuklarda İşlemsel Ağrı Yönetiminde Dikkati Başka Yöne Çekme Yöntemlerinin Kullanımı . Güncel Pediatri , 13 (2) , 116-121
BACKGROUNDNilsson 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: 19230769BACKGROUNDTaşdemir 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
BACKGROUNDTürk Düdükcü, F. & Taş Arslan, F. (2016). Çocuklarda Nebülizatör İle İlaç Uygulama; Problemler Ve Çözüm Önerileri . Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi , 5 (4) , 71-77 .
BACKGROUNDÖzsamuri, 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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Burcu Korkmaz
Tarsus University
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