Pediatric Surgical PatientsNCT06912243
The Effect of Educational Animation on Anxiety and Fear in Children With Tympanostomy Tube Placement in Pediatric Surgery: A Randomized Controlled Trial
A study testing Educational animation about the process of ear tube surgery in people with Pediatric Surgical Patients, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
The study was planned as a randomized controlled experimental research to determine the effect of educational video screening on anxiety and fear in children. All children between the ages of 6-10 years old who underwent ear tube surgery will be included. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Pediatric Surgical Patients
- What is being tested?
- Educational animation about the process of ear tube surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between 6-10 years old
- Having ear tube surgery
- Signing the informed consent form by the patient's legal guardian
Who cannot join
- Previous surgical operation of the child
- The child has had a cleft palate or lip operation before
- Conditions that may prevent communication with parents (e.g. language problem)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bartın University
Merkez, Bartın, 74100
Aylin Kurt, 05382087211, akurt@bartin.edu.tr
About this study
The study was planned as a randomized controlled experimental research to determine the effect of educational video screening on anxiety and fear in children. All children between the ages of 6-10 years old who underwent ear tube surgery will be included. Children will be randomly assigned to two groups (training video group, control group-standard care). In the training video group, a nurse will explain the process of ear tube surgery to the children with an educational video. The scenario of this educational animation will include information about the preoperative fears of a child who will undergo ear tube surgery, the structure of the ear, what they are most curious about, what the ear tube is, what will happen during and after surgery. In the control-standard care group, the standard information given to all children who had ear tube surgery in the relevant service will be given to the children in the control group. Data will be collected with the Sociodemographic Questionnaire, Child Anxiety Scale-Condition Child Fear Scale before and after surgery.
Read the detailed description
When a child becomes ill and undergoes surgery, it can be an event that increases anxiety and fear for both the child and the parents. Parents may experience significant decision conflicts when making decisions about their child's elective surgical treatment, such as ear tube surgery. Children encounter many situations in the hospital that cause anxiety and fear. Especially if there is a surgical intervention plan in the treatment plan of the disease, psychological problems may arise in the child and family members. During the preoperative period, children can be quite stressed. Anxiety-inducing conditions include feeling restless due to the operation, fear of loneliness, feeling of foreignness, fear of pain after surgery, concern about disruption of the integrity of the body and frequent use of medical terms. Reducing anxiety before surgery has positive results in the recovery of the sick child and the parent after surgery. Methods such as preanesthetic drugs, distractions, the presence of the parent with the patient before anesthesia, preoperative training and psychological preparation of both the child and the family for surgery are used to reduce preoperative anxiety.
In the study examining the content of social media posts about ear tubes in children on popular social media platforms Instagram and Facebook, it was determined that most of the posts were made by parents/caregivers in the perioperative period and the rate of educational posts was low. With the increasing importance of patient/family-centered participation in the decision-making process in healthcare services, standardizing the content and increasing the usability of educational materials for surgical procedures commonly performed in children such as ear tube placement should be a priority. Since there are no standardized guidelines on how to write online patient education materials, online patient education materials vary in quality and readability.
This study may provide important information about the ear tube surgery procedure by helping children to focus their attention on positive things rather than stressful events with video and musical interventions, which are both economical and easy to use. To the best of our knowledge, there is no study in the literature examining the effect of video screening on anxiety and fear in children undergoing ear tube surgery. Therefore, this randomized controlled trial was planned to determine the effect of educational video screening on anxiety and fear in children.
- Conditions
- Pediatric Surgical Patients
- Being tested
- Educational animation about the process of ear tube surgery, Control-Standard Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational animation about the process of ear tube surgeryOther
A nurse will explain the process of ear tube surgery to children in an educational video. This educational video scenario includes information about a child's fears before surgery, the structure of the ear, what they are most curious about, what an ear tube is, what happens during and after surgery. The educational video will be made by a person specialized in computer technologies. Artificial intelligence will be used in the vocalization of the educational video. Expert opinion will be taken for the instructional video. The duration of the educational video is planned to be in the range of 3-4 minutes in total.
Control-Standard CareOther
The standard information given to all children who had ear tube surgery in the relevant ward will be given to the children in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Educational animation about the process of ear tube surgery | Experimental | A nurse will explain the process of ear tube surgery to children in an educational video. This educational video scenario includes information about a child's fears before surgery, the structure of the ear, what they are most curious about, what an ear tube is, what happens during and after surgery. The educational video will be made by a person specialized in computer technologies. Artificial intelligence will be used in the vocalization of the educational video. Expert opinion will be taken for the instructional video. The duration of the educational video is planned to be in the range of 3-4 minutes in total. Receives: Other: Educational animation about the process of ear tube surgery |
| Control-Standard Maintenance | Other | Children in the control group will be given the standard information given to all children who had ear tube surgery in the relevant ward. Receives: Other: Control-Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean score of the Children's Anxiety Scale-Situation of the children who watched educational videos after the educaiton video was lower than that of the control group.
The mean score of the Children's Anxiety Scale-Situation of the children who watched educational videos after the educaiton video was lower than that of the control group.
Measured: 12 months
The mean score of the Children's Fear Scale of the children who watched educational videos after the education video was lower than that of the control group.
The mean score of the Children's Fear Scale of the children who watched educational videos after the education video was lower than that of the control group.
Measured: 12 months
Secondary outcomes (2)
Children who watched educational videos had lower mean scores on the Child Anxiety Scale-Situation after the educational video compared to before the educational video.
Children who watched educational videos had lower mean scores on the Child Anxiety Scale-Situation after the educational video compared to before the educational video.
Measured: 12 months
Children who watched educational videos had lower mean scores on the Child Fear Scale after the educational video compared to before.
Children who watched educational videos had lower mean scores on the Child Fear Scale after the educational video compared to before.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start15 Nov 2024
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Surgical PatientsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Kurt, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912243
- Sponsor's protocol ID
- 2024-SBB-0907
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2025
- Last updated
- 8 Apr 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Educational Animation on Anxiety and Fear in Children With Tympanostomy Tube Placement in Pediatric Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06912243
- Acronym / sponsor ID
- 2024-SBB-0907
- Conditions
- Pediatric Surgical Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 4 Apr 2025 (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.
The study was planned as a randomized controlled experimental research to determine the effect of educational video screening on anxiety and fear in children. All children between the ages of 6-10 years old who underwent ear tube surgery will be included. Children will be randomly assigned to two groups (training video group, control group-standard care). In the training video group, a nurse will explain the process of ear tube surgery to the children with an educational video. The scenario of this educational animation will include information about the preoperative fears of a child who will undergo ear tube surgery, the structure of the ear, what they are most curious about, what the ear tube is, what will happen during and after surgery. In the control-standard care group, the standard information given to all children who had ear tube surgery in the relevant service will be given to the children in the control group. Data will be collected with the Sociodemographic Questionnaire, Child Anxiety Scale-Condition Child Fear Scale before and after surgery.
Detailed description
When a child becomes ill and undergoes surgery, it can be an event that increases anxiety and fear for both the child and the parents. Parents may experience significant decision conflicts when making decisions about their child's elective surgical treatment, such as ear tube surgery. Children encounter many situations in the hospital that cause anxiety and fear. Especially if there is a surgical intervention plan in the treatment plan of the disease, psychological problems may arise in the child and family members. During the preoperative period, children can be quite stressed. Anxiety-inducing conditions include feeling restless due to the operation, fear of loneliness, feeling of foreignness, fear of pain after surgery, concern about disruption of the integrity of the body and frequent use of medical terms. Reducing anxiety before surgery has positive results in the recovery of the sick child and the parent after surgery. Methods such as preanesthetic drugs, distractions, the presence of the parent with the patient before anesthesia, preoperative training and psychological preparation of both the child and the family for surgery are used to reduce preoperative anxiety.
In the study examining the content of social media posts about ear tubes in children on popular social media platforms Instagram and Facebook, it was determined that most of the posts were made by parents/caregivers in the perioperative period and the rate of educational posts was low. With the increasing importance of patient/family-centered participation in the decision-making process in healthcare services, standardizing the content and increasing the usability of educational materials for surgical procedures commonly performed in children such as ear tube placement should be a priority. Since there are no standardized guidelines on how to write online patient education materials, online patient education materials vary in quality and readability.
This study may provide important information about the ear tube surgery procedure by helping children to focus their attention on positive things rather than stressful events with video and musical interventions, which are both economical and easy to use. To the best of our knowledge, there is no study in the literature examining the effect of video screening on anxiety and fear in children undergoing ear tube surgery. Therefore, this randomized controlled trial was planned to determine the effect of educational video screening on anxiety and fear in children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational animation about the process of ear tube surgery | Experimental | Other: Educational animation about the process of ear tube surgeryA nurse will explain the process of ear tube surgery to children in an educational video. This educational video scenario includes information about a child's fears before surgery, the structure of the ear, what they are most curious about, what an ear tube is, what happens during and after surgery. The educational video will be made by a person specialized in computer technologies. Artificial intelligence will be used in the vocalization of the educational video. Expert opinion will be taken for the instructional video. The duration of the educational video is planned to be in the range of 3-4 minutes in total. |
| Control-Standard Maintenance | Other | Other: Control-Standard CareChildren in the control group will be given the standard information given to all children who had ear tube surgery in the relevant ward. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Being between 6-10 years old
- Having ear tube surgery
- Signing the informed consent form by the patient's legal guardian
Key exclusion criteria (3 listed)
- Previous surgical operation of the child
- The child has had a cleft palate or lip operation before
- Conditions that may prevent communication with parents (e.g. language problem)
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 |
|---|---|---|
| Educational animation about the process of ear tube surgeryA nurse will explain the process of ear tube surgery to children in an educational video. This educational video scenario includes information about a child's fears before surgery, the structure of the ear, what they are most curious about, what an ear tube is, what happens during and after surgery. The educational video will be made by a person specialized in computer technologies. Artificial intelligence will be used in the vocalization of the educational video. Expert opinion will be taken for the instructional video. The duration of the educational video is planned to be in the range of 3-4 minutes in total. | Other | Educational animation about the process of ear tube surgery |
| Control-Standard CareThe standard information given to all children who had ear tube surgery in the relevant ward will be given to the children in the control group. | Other | Control-Standard Maintenance |
Primary outcome
The mean score of the Children's Anxiety Scale-Situation of the children who watched educational videos after the educaiton video was lower than that of the control group.
Time frame: 12 months
The mean score of the Children's Anxiety Scale-Situation of the children who watched educational videos after the educaiton video was lower than that of the control group.
The mean score of the Children's Fear Scale of the children who watched educational videos after the education video was lower than that of the control group.
Time frame: 12 months
The mean score of the Children's Fear Scale of the children who watched educational videos after the education video was lower than that of the control group.
2 secondary outcomes
Children who watched educational videos had lower mean scores on the Child Anxiety Scale-Situation after the educational video compared to before the educational video.
Time frame: 12 months
Children who watched educational videos had lower mean scores on the Child Fear Scale after the educational video compared to before.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational animation about the process of ear tube surgery in people with Pediatric Surgical Patients, run by Bartın Unıversity at 1 site 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 3 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: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aylin Kurt (+905382087211, aylinkurt67@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean score of the Children's Anxiety Scale-Situation of the children who watched educational videos after the educaiton video was lower than that of the control group. (time frame: 12 months). 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 8 Apr 2025.