SurgeryPerioperativeNCT07062835
Perioperative Preparation Application Developed for Children and Parents
A study testing Perioperative Paediatric Application in people with Surgery, run by Dilek Kucuk Alemdar at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Surgery
- What is being tested?
- Perioperative Paediatric Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2025to 30 Nov 2025
- 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 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Domestic Perioperative Preparation Application Developed for Children and Parents: Digital Serious Health Game-PeroPap (Perioperative Paediatric Application)
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.
Read the detailed description
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. The research will be carried out as a prospective, randomised, controlled experimental study in the Pediatric Surgery Clinic of Ordu University Training and Research Hospital Gynecology and Children's Hospital. The population of the study will consist of children aged 7-10 years who underwent day surgery between the dates of the study. The sample of the study will consist of 348 children and their parents who will undergo day surgery between the specified dates, who meet the case selection criteria and agree to participate in the study. The study participants will be assigned to two groups as experimental (n=174) and control group (n=174) by computer-assisted randomisation. In the first phase of the study, PeroPap design will be created with expert opinions using the serious game development framework. The digital serious health game application PeroPap will be developed as an evidence-based interactive game specifically designed to address relevant challenges faced by the user and change behaviour. Children and parents will be downloaded to their digital devices with Android or IOS operating system by scanning the QR code by the executive via internet connection. Two separate options will be created for the child and parent on the application. 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". The application will also include deep breathing exercises and mindfulness practices to reduce parents' anxiety. 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". Research data will be collected with the Child and Parent Descriptive Information Form, Child Perioperative Follow-up Form, Baxter Nausea Scale-BARF, Eastern Ontario Children's Hospital Pain Scale, Comfort Behaviours Checklist (CBCL), Multidimensional Perioperative Anxiety Scale in Children, Modified Yale Preoperative Anxiety Scale, Postoperative Pain Scale for Parents, State and Trait Anxiety Scale and PedsQL Health Care Parent Satisfaction Scale.
- Conditions
- Surgery
- Being tested
- Perioperative Paediatric Application, Control
- Keywords
- children, day surgery , Perioperative, Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative Paediatric ApplicationBehavioural
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".
ControlOther
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".
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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". Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 1 hour and 2 hours after surgery.
Secondary outcomes (2)
PedsQL Health Care Parental Satisfaction Scale
The questions in the scale aim to measure satisfaction with health care services and psychosocial satisfaction. The scale consists of 25 questions with 6 subheadings: information, family involvement, communication, technical skills, emotional needs and general satisfaction. The questions in the scale are evaluated on a 5-point scale. "0" means never satisfied, "1" means sometimes satisfied, "2" means most of the time satisfied, '3' means almost always satisfied, "4" means always satisfied.
Measured: 30 minutes before discharge
Postoperative Pain Scale for Parents:
It allows parents to assess pain at different times of the day for postoperative pain measurement. The scale includes 15 items, each with a "Yes" or "No" response. Questions with a "Yes" answer are scored and the total score that can be obtained from the scale is at least 15. Scores between 6 and 15 on the scale indicate that "the child has clinically significant pain", while a score between 0 and 6 on the EPAS indicates that the child has pain that does not require intervention.
Measured: 1 hour and 2 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start3 Jul 2025
- Primary completion30 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Model description
- The research will be carried out as a prospective, randomised, controlled experimental study.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilek Kucuk Alemdar
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Sponsor-investigator, Dilek Kucuk Alemdar, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062835
- Sponsor's protocol ID
- KAEK145
- Other IDs
- 2023-A4-04-38223
- Acronym
- Perioperative
- Status last verified
- May 2026
- First submitted
- 3 Jul 2025
- Last updated
- 8 May 2026
- 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 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domestic Perioperative Preparation Application Developed for Children and Parents: Digital Serious Health Game-PeroPap (Perioperative Paediatric Application)
- ClinicalTrials.gov ID
- NCT07062835
- Acronym / sponsor ID
- Perioperative / KAEK145
- Conditions
- Surgery
- Keywords
- children, day surgery , Perioperative, Application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Dilek Kucuk AlemdarUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 14 Jul 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.
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.
Detailed description
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. The research will be carried out as a prospective, randomised, controlled experimental study in the Pediatric Surgery Clinic of Ordu University Training and Research Hospital Gynecology and Children's Hospital. The population of the study will consist of children aged 7-10 years who underwent day surgery between the dates of the study. The sample of the study will consist of 348 children and their parents who will undergo day surgery between the specified dates, who meet the case selection criteria and agree to participate in the study. The study participants will be assigned to two groups as experimental (n=174) and control group (n=174) by computer-assisted randomisation. In the first phase of the study, PeroPap design will be created with expert opinions using the serious game development framework. The digital serious health game application PeroPap will be developed as an evidence-based interactive game specifically designed to address relevant challenges faced by the user and change behaviour. Children and parents will be downloaded to their digital devices with Android or IOS operating system by scanning the QR code by the executive via internet connection. Two separate options will be created for the child and parent on the application. 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". The application will also include deep breathing exercises and mindfulness practices to reduce parents' anxiety. 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". Research data will be collected with the Child and Parent Descriptive Information Form, Child Perioperative Follow-up Form, Baxter Nausea Scale-BARF, Eastern Ontario Children's Hospital Pain Scale, Comfort Behaviours Checklist (CBCL), Multidimensional Perioperative Anxiety Scale in Children, Modified Yale Preoperative Anxiety Scale, Postoperative Pain Scale for Parents, State and Trait Anxiety Scale and PedsQL Health Care Parent Satisfaction Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The research will be carried out as a prospective, randomised, controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Perioperative Paediatric Application Group | Experimental | Behavioral: Perioperative Paediatric ApplicationChildren 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. |
| Control | Active comparator | Other: Control. 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". |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Perioperative Paediatric ApplicationChildren 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". | Behavioural | Perioperative Paediatric Application Group |
| ControlIn 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 |
Primary outcome
Modified Yale Preoperative Anxiety Scale:
Time frame: 1 day before surgery, 1 hour before surgery, 15 minutes before surgery, 1 hour and 2 hours after surgery.
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)
Eastern Ontario Children's Hospital Pain Scale
Time frame: Postoperative 1st hour and 2nd hour.
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.
Multidimensional Perioperative Anxiety Scale:
Time frame: 1 day before surgery, 1 hour before, 15 minutes before, 1 hour and 2 hours after surgery.
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
Comfort Behavior Checklist (CBCL):
Time frame: 1 hour and 2 hours after surgery.
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
2 secondary outcomes
PedsQL Health Care Parental Satisfaction Scale
Time frame: 30 minutes before discharge
Postoperative Pain Scale for Parents:
Time frame: 1 hour and 2 hours after surgery.
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 8 May 2026.
- Individual participant dataSharing planned: No
Related trials for Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative Paediatric Application in people with Surgery, run by Dilek Kucuk Alemdar 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 7 inclusion and 4 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 8 May 2026. 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?
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?
Modified Yale Preoperative Anxiety Scale: (time frame: 1 day before surgery, 1 hour before surgery, 15 minutes before surgery, 1 hour and 2 hours after surgery.). The study lists 4 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 May 2026.