Perioperative Preparation Application Developed for Children and Parents

NCT07062835 | Recruiting

• 2 other identifiers: KAEK1452023-A4-04-38223
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

Approaches to increase the compliance of children and parents in daily surgical interventions in children are limited. The primary aim of this study is to evaluate the clinical usability of the Paediatric Perioperative Preparation Game Application-PeroPap, which will be developed to prepare children and parents for day surgery. The secondary aim is to investigate its effect on the perioperative adaptation process of children and parents, children's symptoms such as pain, anxiety, nausea, vomiting and postoperative behavioural changes, and parents' anxiety and satisfaction.

Conditions

Surgery

Keywords

children, day surgery , Perioperative, Application

Outcome Measures

Primary Outcomes (4)

• Modified Yale Preoperative Anxiety Scale:

  In this scale, there are 22 items under 5 categories (activity, speech, emotional state, degree of arousal, relationship with family), each representing a different area of the child's anxiety, and the pediatric patient is evaluated at different points in the preoperative phase. Each category is calculated by taking a score between 0 and 4 (0-6 for the speech category) according to the patient's behavior. During the calculation, a total score of 33-100 is obtained by multiplying the decimal values obtained by dividing the score between 0-4 divided by 4 for 4 categories consisting of 4 items by the decimal value obtained by dividing the score between 0-6 divided by 6 for 1 category consisting of 6 items by 20 (100/total number of categories)

  1 day before surgery, 1 hour before surgery, 15 minutes before surgery, 1 hour and 2 hours after surgery.

• Eastern Ontario Children's Hospital Pain Scale

  The scale evaluates six sub-items of the scale including crying, facial expression, verbal expression, body, touch, and legs in the postoperative period. In the scale; the first item (Crying) can score a minimum of 1 point and a maximum of 3 points, items 2 (Facial expression) and 3 (Verbal expression) can score a minimum of 0 points and a maximum of 2 points, items 4 (Body), 5 (Touch) and 6 (Legs) can score a minimum of 1 point and a maximum of 2 points. The total score from the scale is evaluated as a minimum of 4 and a maximum of 13 points. A high total score on the scale indicates that the child has high pain in the postoperative period.

  Postoperative 1st hour and 2nd hour.

• Multidimensional Perioperative Anxiety Scale:

  The scale is a visual analog scale prepared for children between the ages of 7-13 who will undergo day surgery, consisting of 5 items and scored between 0-100. An increase in the score obtained from the scale indicates that the child's perioperative anxiety increases

  1 day before surgery, 1 hour before, 15 minutes before, 1 hour and 2 hours after surgery.

• Comfort Behavior Checklist (CBCL):

  The PACCL consists of 30 behavioral indicators, pain and comfort scores. High scores indicate a high comfort level. If all questions are answered, the minimum score that can be obtained from the scale is 25 and the maximum score is 100

  1 hour and 2 hours after surgery.

Secondary Outcomes (2)

• PedsQL Health Care Parental Satisfaction Scale

  30 minutes before discharge

• Postoperative Pain Scale for Parents:

  1 hour and 2 hours after surgery.

Study Arms (2)

Perioperative Paediatric Application Group

EXPERIMENTAL

Children in the experimental group will start receiving interactive perioperative preparation training with the PeroPap application 1 day before surgery and play the PeroPap game. Children will learn about the operation process by watching and playing the PeroPap character's cartoon story about the operation process. They will also listen to the song "PeroPap is having surgery" and play the "PeroPap Game" in the application, which they can play before and after surgery.

Behavioral: Perioperative Paediatric Application

Control

ACTIVE COMPARATOR

. In order to meet the perioperative health care needs of the children and their parents in the control group, when they applied to the outpatient clinic for anaesthesia consultation on the working day before the operation, standard individualised care interventions will be provided according to their needs preoperatively and until their discharge, and children and parents will be given surgery preparation training with the education booklet "PeroPap is Having Surgery".

Other: Control

Interventions

Perioperative Paediatric Application BEHAVIORAL

Children in the experimental group will start receiving interactive perioperative preparation training with the PeroPap application 1 day before surgery and play the PeroPap game. Children will learn about the operation process by watching and playing the PeroPap character's cartoon story about the operation process. They will also listen to the song "PeroPap is having surgery" and play the "PeroPap Game" in the application, which they can play before and after surgery. At the same time, in the parent module, information will be provided for parents with the cartoon story "PeroPap is Having Surgery".

Perioperative Paediatric Application Group

Control OTHER

In order to meet the perioperative health care needs of the children and their parents in the control group, when they applied to the outpatient clinic for anaesthesia consultation on the working day before the operation, standard individualised care interventions will be provided according to their needs preoperatively and until their discharge, and children and parents will be given surgery preparation training with the education booklet "PeroPap is Having Surgery".

Control

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child is between 7 and 10 years old,
• The child receives general anesthesia
• The child is hospitalized for a surgical operation,
• Voluntariness of parents and children to participate in the study,
• The child has no visual, hearing or mental disabilities,
• The parent or child has an Android or IOS device with an internet connection,
• Written and verbal consent from parents and children.

You may not qualify if:

• The child has a hearing problem,
• The child and parent are not comfortable speaking and understanding Turkish,
• The child is not at the level of mental development to answer the questions asked,
• Lack of a primary caregiver.

Sponsors & Collaborators

• Dilek Kucuk Alemdar: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

Ordu University

Altinordu, Ordu, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Dilek Küçük Alemdar, Professor

CONTACT

+905468435840; dilekkucukalemdar@gmail.com

Onur Yalçın, Dr

CONTACT

0506 657 2363; onuryalcin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: After the children who meet the inclusion criteria are randomly assigned to the study groups, the children and their parents will be informed which group they are included in and their written consent will be obtained through the informed consent form. Since the project coordinator will provide information about the use of the application, it will not be blinded. However, the doctor who will perform the surgery will not know which group the children are in. In addition, in order to prevent detection bias, the output measurements of the study will be made by the nurse who does not know who is in the experimental group and who is in the control group. In order to prevent bias in the evaluation of the data, the study groups will be coded in the database as A and B by a person outside the scope of the research, and the data will be analyzed by a statistical expert independent of the research. It was aimed to prevent statistical and reporting bias by blinding in terms of output measurements
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The research will be carried out as a prospective, randomised, controlled experimental study.

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: July 3, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)