NCT05099302

Brief Summary

This study was conducted as a randomized controlled experimental study to determine the effect of cartoon in reducing pre-operative fear in children aged 4-10 years who came to the operating room. The data of the study were obtained from children between 4-10 years old who came to Mersin University Hospital Operating Room Unit between 1 July and 30 August 2020. The sample size was determined as a total of 116 children, including 58 children for each group. "Observation Form, Children's Fear Scale (CFS), Tablet Computer, Stopwatch" was used for data collection. The data were evaluated using percentage, mean, standard deviation, chi-square, t test, Anova and Tukey advanced analysis test. Cartoons group; When the children came to the operating room waiting room, the first stopwatch was started as soon as they entered the room to determine the length of stay in the waiting room, and it was turned off while they were entering the operating room with the anesthesiologist. Thus, the total length of stay in the room was determined and recorded. The second stopwatch was started as soon as the child began to cry, and was turned off when the crying stopped. Thus, the crying time of each child was also evaluated. After each parent signed the Informed Consent Form, the Interview and Observation Form was filled. Then the child's heart rate was measured and recorded. The child's fear level was evaluated separately by the child, parent and observer via CFS and recorded in the data collection form. After the initial assessment was completed, the child was asked if he wanted to watch cartoons. "Snow Queen" for girls who want to watch cartoons and "Spider-Man" cartoons for boys started to be watched by tablet. The period of watching cartoons lasted until the child left the waiting room. The heart rate was measured just before the child left the waiting room at the time of surgery. The level of fear was evaluated separately by the child, parent and observer via CFS and recorded in the form. Then, the child was taken to the operating room with the anesthesiologist and observer. Parents are separated from their children in the waiting room. After the child who came to the operating room was taken to the operating table, the pulse rate and the level of fear were evaluated and recorded by the observer via CFS. Control group: All processing steps were carried out similarly to the cartoon group. In this group, the option of playing toys was offered instead of cartoons.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

January 14, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
Last Updated

January 10, 2025

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

September 28, 2021

Last Update Submit

January 9, 2025

Conditions

Keywords

preoperative periodwatching cartoonsfear in children

Outcome Measures

Primary Outcomes (2)

  • Fear Scores

    Changes from Baseline in Visual Analogue Scale Fear Scores in Children with Operation-Related Fear Evaluated by CFS at Entrance to the Operating Room, Leaving the Waiting Room, and at the Operating Table.

    15 minutes

  • Heart Rate

    Changes from Baseline in heart rate in Children with Operation-Related at Entrance to the Operating Room, Leaving the Waiting Room, and at the Operating Table.

    15 minutes

Study Arms (2)

cartoon group

EXPERIMENTAL

In the research, the group whose fear was tried to be reduced by watching cartoons

Other: divert attention

control group

NO INTERVENTION

The group whose change in the process was monitored without any intervention in the research

Interventions

In order to reduce the fears of the children who came to the waiting room before the operation, they watched cartoons and their attention was diverted to another point.

cartoon group

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • the child;
  • Age between 4-10 years
  • Children's perception level to evaluate the scale of fear
  • The child does not have any physical or mental illness
  • The child's ability to communicate and be open to communication
  • The child does not have a hearing, speech or vision problem
  • The child does not have a long-term illness
  • The child and his parents agree to participate in the study.

You may not qualify if:

  • The child is less than 4 years old or over 10 years old,
  • The presence of any chronic disease, physical or mental illness that may affect the child's fear state
  • Child or family refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

KaramanogluMehmetbeyU

Karaman, Turkey, 70100, Turkey (Türkiye)

Location

Karamanoglu Mehmetbey University

Karaman, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 29, 2021

Study Start

January 14, 2021

Primary Completion

August 27, 2021

Study Completion

August 27, 2021

Last Updated

January 10, 2025

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations