Day SurgeryNCT05320614
Education for Children Who Will Have Planned Surgery With Web-based and Therapeutic Game Method
A study testing Web-Based Education and Routine maintenance Training in people with Day Surgery, run by Muğla Sıtkı Koçman University at 2 sites in Turkey (Türkiye).
Trial summary
This research was planned to determine the effects of the web-based education given at home to children aged 7-12 in planned surgeries and the therapeutic game method applied in the hospital on pre-operative anxiety and fear, postoperative pain and sleep. This study is a randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Day Surgery
- What is being tested?
- Web-Based Education and Routine maintenance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Mar 2022to 20 Dec 2023
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Agreeing to participate in the research,
- Those who will have a planned surgery between the ages of 7-12,
- Having and able to use a computer/tablet and internet connection at home,
- Having the ability to use a computer / tablet,
- Pediatric patients given written consent by their parents
Who cannot join
- At least one previous experience of surgery
- Having communication problems (sight, hearing, mental),
- Diagnosed with anxiety disorder,
- Genetic/congenital disease,
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
MSKU
Muğla, Menteşe, 48000
Derya DEMİR UYSAL
Muğla, 48000
About this study
Official title: The Effect Of Web-Based Educatıon And Therapeutıc Game Method Gıven To Chıldren In Planned Surgery On Pre-Surgery Anxıety And Fear On Post-Operatıve Paın And Sleep
This research was planned to determine the effects of the web-based education given at home to children aged 7-12 in planned surgeries and the therapeutic game method applied in the hospital on pre-operative anxiety and fear, postoperative pain and sleep.
This study is a randomized controlled experimental study.
Read the detailed description
Illness and especially hospitalization in the preoperative and postoperative period cause trauma with physiological, emotional and behavioral problems for children. With the help of web-based education and therapeutic game methods by pediatric nurses, anxiety, fear and pain seen in children and families can be reduced and skills to cope with negative emotions can be improved.
This research was planned to determine the effects of the web-based education given at home to children aged 7-12 in planned surgeries and the therapeutic game method applied in the hospital on pre-operative anxiety and fear, postoperative pain and sleep.
This study is a randomized controlled experimental study. The study is planned to be performed in the pediatric surgery clinic of the Training and Research Hospital.
For sample selection, children will be stratified in terms of age variables and divided into two strata as 7-9 years old and 10-12 years old. In order to ensure homogeneity between the groups, children will be selected into the study and control groups using a simple randomization method and a random numbers table. To the children in the study group and their parents; information about the child's surgery, educational brochures including the conditions to be considered before, during and after the operation, during the discharge period, operating room tour, educational games, etc. Training will be given on the website using and a therapeutic game will be played in the game room at the hospital the day before the surgery. The children in the control group and their parents will be given routine care and information about the pre-operative preparation in the service. Descriptive statistics, Chi-square test will be used in the evaluation of the data. A value of p<0.05 will be considered statistically significant.
- Conditions
- Day Surgery
- Being tested
- Web-Based Education, Routine maintenance Training
- Keywords
- Web-based education,, therapeutic play, anxiety, pain, fear
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based EducationOther
Web-Based Education Information about the operation that the child will undergo; animation films about the hospital, the operating room and the medical equipment to be used; training with presentation including methods of coping with anxiety, fear and pain, postoperative wound care, possible complications in nutrition and nursing care; educational games Education with Therapeutic Play Method Training with the therapeutic game method for 30-45 minutes in the game room in the service one day before the surgery
Routine maintenance TrainingOther
Explaining the routine care given to the child and parent in the control group by the pediatric surgery nurse in the service.
| Study group | Role | What they receive |
|---|---|---|
| case 1 | Experimental | Case Group:Web-Based Education Information about the operation that the child will undergo; animation films about the hospital, the operating room and the medical equipment to be used; training with presentation including methods of coping with anxiety, fear and pain, postoperative wound care, possible complications in nutrition and nursing care; educational games Education with Therapeutic Play Method Training with the therapeutic game method for 30-45 minutes in the game room in the service one day before the surgery Receives: Other: Web-Based Education |
| control 1 | Experimental | Control Group: Explaining the routine care given in the service by the pediatric surgery nurse to the child and parent in the control group. Receives: Other: Routine maintenance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Fear Scale:
This scale is scored between 0-4 based on five different facial expressions, a higher scale score indicates more fear.
Measured: On the day of the operation, one hour before the operation, the child is asked to rate his/her fear according to this scale.
Secondary outcomes (1)
Yale Modified Preoperative Anxiety Scale Child Form
This scale has four parameters, each parameter is scored between 0-4, the second parameter is scored between 0-6. A total of minimum 4 and maximum 18 points can be obtained from the scale. High scores indicate high anxiety.
Measured: An evaluation is made by the researcher 30 minutes before the operation and when the anesthesia mask is shown in the operating room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start10 Mar 2022
- Primary completion24 Apr 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Day 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Collaborators
- Aydin Adnan Menderes University
- Responsible party
- Principal investigator, Derya Demir Uysal, Muğla Sıtkı Koçman University
- Investigators
- Hüsniye ÇALIŞIR, Prof.Dr, Study director, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320614
- Sponsor's protocol ID
- MSKU UYSAL-001
- Status last verified
- Jan 2025
- First submitted
- 4 Mar 2022
- Last updated
- 13 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Web-Based Educatıon And Therapeutıc Game Method Gıven To Chıldren In Planned Surgery On Pre-Surgery Anxıety And Fear On Post-Operatıve Paın And Sleep
- ClinicalTrials.gov ID
- NCT05320614
- Acronym / sponsor ID
- MSKU UYSAL-001
- Conditions
- Day Surgery
- Keywords
- Web-based education,, therapeutic play, anxiety, pain, fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Collaborators
- Aydin Adnan Menderes University
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 11 Apr 2022 (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 research was planned to determine the effects of the web-based education given at home to children aged 7-12 in planned surgeries and the therapeutic game method applied in the hospital on pre-operative anxiety and fear, postoperative pain and sleep.
This study is a randomized controlled experimental study.
Detailed description
Illness and especially hospitalization in the preoperative and postoperative period cause trauma with physiological, emotional and behavioral problems for children. With the help of web-based education and therapeutic game methods by pediatric nurses, anxiety, fear and pain seen in children and families can be reduced and skills to cope with negative emotions can be improved.
This research was planned to determine the effects of the web-based education given at home to children aged 7-12 in planned surgeries and the therapeutic game method applied in the hospital on pre-operative anxiety and fear, postoperative pain and sleep.
This study is a randomized controlled experimental study. The study is planned to be performed in the pediatric surgery clinic of the Training and Research Hospital.
For sample selection, children will be stratified in terms of age variables and divided into two strata as 7-9 years old and 10-12 years old. In order to ensure homogeneity between the groups, children will be selected into the study and control groups using a simple randomization method and a random numbers table. To the children in the study group and their parents; information about the child's surgery, educational brochures including the conditions to be considered before, during and after the operation, during the discharge period, operating room tour, educational games, etc. Training will be given on the website using and a therapeutic game will be played in the game room at the hospital the day before the surgery. The children in the control group and their parents will be given routine care and information about the pre-operative preparation in the service. Descriptive statistics, Chi-square test will be used in the evaluation of the data. A value of p<0.05 will be considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case 1 | Experimental | Other: Web-Based EducationCase Group:Web-Based Education Information about the operation that the child will undergo; animation films about the hospital, the operating room and the medical equipment to be used; training with presentation including methods of coping with anxiety, fear and pain, postoperative wound care, possible complications in nutrition and nursing care; educational games Education with Therapeutic Play Method Training with the therapeutic game method for 30-45 minutes in the game room in the service one day before the surgery |
| control 1 | Experimental | Other: Routine maintenance TrainingControl Group: Explaining the routine care given in the service by the pediatric surgery nurse to the child and parent in the control group. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Agreeing to participate in the research,
- Those who will have a planned surgery between the ages of 7-12,
- Having and able to use a computer/tablet and internet connection at home,
- Having the ability to use a computer / tablet,
- Pediatric patients given written consent by their parents
Key exclusion criteria (4 listed)
- At least one previous experience of surgery
- Having communication problems (sight, hearing, mental),
- Diagnosed with anxiety disorder,
- Genetic/congenital disease,
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 |
|---|---|---|
| Web-Based EducationWeb-Based Education Information about the operation that the child will undergo; animation films about the hospital, the operating room and the medical equipment to be used; training with presentation including methods of coping with anxiety, fear and pain, postoperative wound care, possible complications in nutrition and nursing care; educational games Education with Therapeutic Play Method Training with the therapeutic game method for 30-45 minutes in the game room in the service one day before the surgery | Other | case 1 |
| Routine maintenance TrainingExplaining the routine care given to the child and parent in the control group by the pediatric surgery nurse in the service. | Other | control 1 |
Primary outcome
Child Fear Scale:
Time frame: On the day of the operation, one hour before the operation, the child is asked to rate his/her fear according to this scale.
This scale is scored between 0-4 based on five different facial expressions, a higher scale score indicates more fear.
1 secondary outcome
Yale Modified Preoperative Anxiety Scale Child Form
Time frame: An evaluation is made by the researcher 30 minutes before the operation and when the anesthesia mask is shown in the operating room.
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 13 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.
Hüsniye ÇALIŞIR, Prof.Dr study director
Aydin Adnan Menderes University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Education and Routine maintenance Training in people with Day Surgery, run by Muğla Sıtkı Koçman University 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 5 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 13 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?
Child Fear Scale: (time frame: On the day of the operation, one hour before the operation, the child is asked to rate his/her fear according to this scale.). 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 13 Jan 2025.