PreoperativeNCT05099302
The Effect of Cartoons Watched Before Surgery on Children's Fear Level
A study testing divert attention in people with Preoperative and Cartoon, run by Ayse Sonay Turkmen, Prof.Dr at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Preoperative, Cartoon, Fear
- What is being tested?
- divert attention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 14 Jan 2021to 27 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
KaramanogluMehmetbeyU
Karaman, Turkey, 70100
Karamanoglu Mehmetbey University
Karaman
About this study
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.
Read the detailed description
The research will be carried out in the Operating Room Unit of X University Hospital. There are 20 surgical specialists, eight anesthesiologists, 35 nurses, 25 anesthesia technicians, 30 support personnel, and personnel working in 13 different areas (such as secretary, consumables warehouse manager) in the operating room unit. The personnel working in the unit working in shifts work in shifts between 08.00-16.00, 16.00-08.00 and 16.00-24.00. There are 16 operating rooms in total in the operating room unit. Apart from these rooms, there are pre-operative patient waiting room, pre-operative pediatric waiting room and postoperative patient/children's rooms. There are also rest rooms for the personnel working in the operating room and a 10-bed reanimation unit. The pre-operative pediatric waiting room is located at the patient admission entrance of the operating room and is not a sterile area. It has an average size of 40 m2 and includes a television, two beds, two armchairs and toys. There are cartoon characters and pictures on the walls of the waiting room. Before the operation, children spend an average of 5-20 minutes in the children's waiting room after the operation. is brought first. After the necessary procedures are performed by the preop nurse, the child is taken to the operating room in the presence of an anesthesiologist and anesthesiologist.
The sample size was calculated with 95% power, with 10% difference at 0.05 significance level, taking into account the known score (4.53 ± 3.23) with the G*Power 3.1.5 program. The sample size was determined as 58 children for each group. A total of 116 children were not reached. At the end of the study, Post Hoc power analysis will also be carried out in order to determine the adequacy of the number of children included in the study, and if 95% power is reached, the data collection process will be terminated.
Randomization of control and study groups; The status of the children to be included in the study in the control or study group will be determined by using "stratification and randomization methods with blocks". In the literature, it has been reported that among the factors affecting the fear and anxiety experienced by children in interventional procedures, variables such as age, gender and fear of interventional procedure are included. Accordingly, block randomization will be applied by stratifying the children as "girl and boy" for the gender variable and "4 years, 5 years and 6 years and over" for the age variable. 58 children will be included in each of the research groups. During the data collection process, each child and his/her family will be taken to the operating room waiting room one by one. This will prevent children from meeting each other.
- Conditions
- Preoperative, Cartoon, Fear, Appendectomy, Tonsillectomy
- Being tested
- divert attention
- Keywords
- preoperative period, watching cartoons, fear in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
divert attentionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| cartoon group | Experimental | In the research, the group whose fear was tried to be reduced by watching cartoons Receives: Other: divert attention |
| control group | No intervention | The group whose change in the process was monitored without any intervention in the research |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start14 Jan 2021
- Primary completion27 Aug 2021
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayse Sonay Turkmen, Prof.Dr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayse Sonay Turkmen, Prof.Dr, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099302
- Sponsor's protocol ID
- CARTOONS1
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cartoons Watched Before Surgery on Children's Fear Level
- ClinicalTrials.gov ID
- NCT05099302
- Acronym / sponsor ID
- CARTOONS1
- Conditions
- Preoperative, Cartoon, Fear, Appendectomy, Tonsillectomy
- Keywords
- preoperative period, watching cartoons, fear in children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Ayse Sonay Turkmen, Prof.DrUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research will be carried out in the Operating Room Unit of X University Hospital. There are 20 surgical specialists, eight anesthesiologists, 35 nurses, 25 anesthesia technicians, 30 support personnel, and personnel working in 13 different areas (such as secretary, consumables warehouse manager) in the operating room unit. The personnel working in the unit working in shifts work in shifts between 08.00-16.00, 16.00-08.00 and 16.00-24.00. There are 16 operating rooms in total in the operating room unit. Apart from these rooms, there are pre-operative patient waiting room, pre-operative pediatric waiting room and postoperative patient/children's rooms. There are also rest rooms for the personnel working in the operating room and a 10-bed reanimation unit. The pre-operative pediatric waiting room is located at the patient admission entrance of the operating room and is not a sterile area. It has an average size of 40 m2 and includes a television, two beds, two armchairs and toys. There are cartoon characters and pictures on the walls of the waiting room. Before the operation, children spend an average of 5-20 minutes in the children's waiting room after the operation. is brought first. After the necessary procedures are performed by the preop nurse, the child is taken to the operating room in the presence of an anesthesiologist and anesthesiologist.
The sample size was calculated with 95% power, with 10% difference at 0.05 significance level, taking into account the known score (4.53 ± 3.23) with the G*Power 3.1.5 program. The sample size was determined as 58 children for each group. A total of 116 children were not reached. At the end of the study, Post Hoc power analysis will also be carried out in order to determine the adequacy of the number of children included in the study, and if 95% power is reached, the data collection process will be terminated.
Randomization of control and study groups; The status of the children to be included in the study in the control or study group will be determined by using "stratification and randomization methods with blocks". In the literature, it has been reported that among the factors affecting the fear and anxiety experienced by children in interventional procedures, variables such as age, gender and fear of interventional procedure are included. Accordingly, block randomization will be applied by stratifying the children as "girl and boy" for the gender variable and "4 years, 5 years and 6 years and over" for the age variable. 58 children will be included in each of the research groups. During the data collection process, each child and his/her family will be taken to the operating room waiting room one by one. This will prevent children from meeting each other.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cartoon group | Experimental | Other: divert attentionIn the research, the group whose fear was tried to be reduced by watching cartoons |
| control group | No intervention | –The group whose change in the process was monitored without any intervention in the research |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| divert attentionIn 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. | Other | cartoon group |
Primary outcome
Fear Scores
Time frame: 15 minutes
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.
Heart Rate
Time frame: 15 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing divert attention in people with Preoperative and Cartoon, run by Ayse Sonay Turkmen, Prof.Dr at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear Scores (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.