Clinical trial NCT05303454: Cartoons and Musical-moving Toys in Invasive Procedure Applications Reduce Pain and Fear Levels of Children
Official title: Cartoons and Musical-moving Toys in Invasive Procedure Applications Reduce Pain and Fear Levels of Children: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Disorder
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: The aim of this study is to determine the effect of the cartoon and musical-moving toy watched in the invasive procedure application on the pain and fear level of children.

Material and Method: The research was carried out as a randomized controlled experiment in Atatürk University Health Research and Application Center Pediatric Emergency Service between March 2021 and February 2022. The population of the study consisted of children between the ages of 3 and 6 who came for treatment at the specified hospital. The sample of the research; 40 cartoons, 40 musical-moving toys, 40 control group, totally 120 children who applied to the pediatric emergency service between June 2021 and January 2022 and met the research criteria and volunteered to participate in the research. Data collection tools were collected through face-to-face interviews with "Survey Form", "Wong-Baker Faces Pain Rating Scale (WBS)" and "Child Fear Scale (CFS)". In the research, "cartoon" and "musical-moving toy" were used as intervention tools.

Detailed description: Aim: The aim of this study is to determine the effect of the cartoon and musical-moving toy watched in the invasive procedure application on the pain and fear level of children.

Material and Method: The research was carried out as a randomized controlled experiment in Atatürk University Health Research and Application Center Pediatric Emergency Service between March 2021 and February 2022. There is one intervention room in the Pediatric Emergency Service. There are blood collection stretcher, vascular access-bleeding materials (intraket, cotton, 70% alcohol, tourniquet, plaster, injector, blood tubes, etc.) in this room.The population of the study consisted of children between the ages of 3 and 6 who came for treatment at the specified hospital. In order to ensure randomization, the children who met the criteria were included in the control group in the first week, the children in the second week were included in the cartoon group, and the children in the third week were included in the musical-moving toy group, and this cycle was continued until the end of the study and randomization was achieved.The sample of the research; 40 cartoons, 40 musical-moving toys, 40 control group, totally 120 children who applied to the pediatric emergency service between June 2021 and January 2022 and met the research criteria and volunteered to participate in the research. Children from 2 experimental and 2 control groups who did not want to participate in the study were excluded from the study. Prior power analysis was performed to determine the adequacy of the sample size of the study. In the power analysis, it was determined that the study was at the significance level of 0.05, at the 95% confidence interval, and the effect size was 0.551 and the power was 0.99. Data collection tools were collected through face-to-face interviews with "Survey Form", "Wong-Baker Faces Pain Rating Scale (WBS)" and "Child Fear Scale (CFS)". In the research, "cartoon" and "musical-moving toy" were used as intervention tools. Two different cartoons were used in the research, and these were the children's favorites, 'Red Fish' and 'Niloya'. Pepee is a toy suitable for the developmental characteristics of children aged three and over. The data were analyzed with the SPSS for Windows 22 package program. Ethical principles were followed in the research. The research sample is limited to pediatric patients who applied to Atatürk University Health Research and Application Center Pediatric Emergency Service between June and December 2021 and participated in the study voluntarily. Research results can be generalized to this group.

Eligibility criteria: Inclusion Criteria:

* between 3-6 years old,
* Does not have a chronic disease,
* Does not have a disability related to developmental areas,
* Not receiving inpatient treatment in the hospital,
* No history of sedative, analgesic or narcotic substance use within 24 hours before admission,
* Not having a febrile illness at the time of application,
* Children whose parents were with the child during the procedure were included in the study.

Exclusion Criteria:

* NOT aged between 3-6 years,
* Having a chronic illness
* Having a disability related to developmental areas,
* Receiving inpatient treatment in the hospital,
* Having a history of sedative, analgesic or narcotic substance use within 24 hours before admission,
* Having a febrile illness at the time of application,
* Children whose parents were not present during the procedure were included in the study.

Primary outcomes:
measure: Wong-Baker Facial Expression Rating Scale
timeFrame: 8 MONTHS
measure: Child Fear Scale
timeFrame: 8 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Nursing of Faculty
state: Center
Study officials:
affiliation: Ataturk University
name: ARZU SARIALİOĞLU, PHD
role: STUDY_DIRECTOR
References: