The Effect of Educational Animation on Anxiety and Fear in Children With Tympanostomy Tube Placement in Pediatric Surgery: A Randomized Controlled Trial

NCT06912243 | Recruiting

• 1 other identifier: 2024-SBB-0907
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pediatric Surgical Patients

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  12 months

• Children who watched educational videos had lower mean scores on the Child Fear Scale after the educational video compared to before.

  12 months

Study Arms (2)

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.

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.

Other: Control-Standard Care

Interventions

Educational animation about the process of ear tube surgery OTHER

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.

Educational animation about the process of ear tube surgery

Control-Standard Care OTHER

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.

Control-Standard Maintenance

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being between 6-10 years old
• Having ear tube surgery
• Signing the informed consent form by the patient's legal guardian

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bartın Unıversity: lead

Study Sites (1)

Bartın University

Merkez, Bartın, 74100, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Aylin Kurt

CONTACT

+905382087211; aylinkurt67@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 4, 2025
• Study Start: November 15, 2024
• Primary Completion: November 15, 2025
• Study Completion: December 15, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)