HealthyNCT05104021
Environmental Game After Appendicitis Surgery
A study testing game in people with Healthy, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to determine the effect of environmental play and mobilization on fear and pain levels of children aged 6-12 years who had acute appendicitis surgery. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- game
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 May 2019
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being between 6-12 years old,
- Being open to communication and cooperation,
- No visual or hearing impairment,
- Appendectomy surgery,
- First mobilization after surgery.
- Parent's willingness to participate in the study can be sorted.
Who cannot join
- Having a mental or neurological disability,
- Children with hearing and vision impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul okan university
Tuzla, Istanbul, 34959
About this study
Official title: The Effect of Mobilization of Environmental Play on Fear and Pain Levels in the Postoperative Period Between 6-12 Years Old Children With Acute Appendicitis
This study was conducted to determine the effect of environmental play and mobilization on fear and pain levels of children aged 6-12 years who had acute appendicitis surgery.
Read the detailed description
It was conducted with children aged 6-12 years in the postoperative period in a randomized controlled manner. Children in the intervention (n:50) group were mobilized by playing environmental games.The children in the control group (n:50) underwent routine mobilization of the clinic.
The data were collected with the "Child Follow-up Form", which was created to evaluate the child's demographic characteristics, physiological parameters, pain and fear.
- Conditions
- Healthy
- Being tested
- game
- Keywords
- Pain, Fear, Pediatric surgery, Game, Appendicitis
- Medical subject headings
- Pain, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gameDevice
The game is played with a maximum of four people. Beginning points are marked with blue, red, yellow and green colors, the game progress direction is The starting color for the player is determined with the help of arrows. Dice with the biggest number The child who throws starts the game first from the starting point that belongs to him. Play ground Each child who completes a circuit around him reads from his second point. it tries to go inwards (to the world square) in the direction it points. Equivalent to card check box The next child draws one of the face down cards. the instruction written on the back of the card.
implements. Then he puts the card on the back of the other cards. Cards are reward (go forward), penalty (backward) git) cards. Coming second to the same frame during the game The child first starts the game from the starting point of the child in the square. First The child who manages to enter the world square wins the game.
| Study group | Role | What they receive |
|---|---|---|
| game group | Experimental | Children who accepted to participate in the game were taken to the playground with minimum two and maximum four people. After the children were introduced to each other, the rules of the game were explained. Between the children playing, dice were rolled to determine the starting order of the game. The player who scored the highest number had the right to start the game first. With the help of the stopwatch, the playing time was started, and the children played the game in accordance with the rules.
For the child who first reached the square of the world, the time was stopped and recorded in the "Child Follow-up Form". The game was played with a maximum game duration of 15 minutes. In the same way, the times of the children who reached the world square in the second, third and fourth places were recorded on the "Follow-up Form". Receives: Device: game |
| control group | No intervention | Children in the control group were allowed to walk for 15 minutes on a flat surface in the clinic accompanied by the researcher and their parents. As soon as the child came out of his room, the time was started with the help of a stopwatch. The time was stopped when the child went back to bed. The pain and fear scores of each child who completed the game and mobilization were evaluated separately and simultaneously by the child, parent and researcher with the help of the "Visual Analog Scale" and the "Child Fear Scale", and then the physiological parameter measurements were made by the researcher and the "Child Follow-up Form" was evaluated after the procedure. and data collection was terminated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of environmental play on premobilization pain score of children
Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
Measured: 30 seconds
The effect of environmental play on the postmobilization pain score of children
Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
Measured: 30 seconds
The effect of environmental play on children's fear score before mobilization
Child Fear Scale (CFS) was used for determine fear score in this research. Scale got 0 to 4 points (0 (good) to 4 (bad)).
Measured: 30 seconds
The effect of environmental play on children's fear score after mobilization
Child Fear Scale (CFS) was used for determine fear score in this research. Scale got 0 to 4 points (0 (good) to 4 (bad)).
Measured: 30 seconds
The effect of environmental play on the pulse rate of children before mobilization
pulse rate
Measured: 60 seconds
The effect of environmental play on the pulse rate of children after mobilization
pulse rate
Measured: 60 seconds
The effect of environmental play on the blood pressure of children before mobilization
blood pressure
Measured: 60 seconds
The effect of environmental play on the blood pressure of children after mobilization
blood pressure
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Nov 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Kanuni Sultan Suleyman Training and Research Hospital
- Responsible party
- Principal investigator, Melike Yilmaz Akdag, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104021
- Sponsor's protocol ID
- 2018.06.01
- Status last verified
- Oct 2021
- First submitted
- 19 Aug 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobilization of Environmental Play on Fear and Pain Levels in the Postoperative Period Between 6-12 Years Old Children With Acute Appendicitis
- ClinicalTrials.gov ID
- NCT05104021
- Acronym / sponsor ID
- 2018.06.01
- Conditions
- Healthy
- Keywords
- Pain, Fear, Pediatric surgery, Game, Appendicitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Kanuni Sultan Suleyman Training and Research Hospital
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 2 Nov 2021 (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 study was conducted to determine the effect of environmental play and mobilization on fear and pain levels of children aged 6-12 years who had acute appendicitis surgery.
Detailed description
It was conducted with children aged 6-12 years in the postoperative period in a randomized controlled manner. Children in the intervention (n:50) group were mobilized by playing environmental games.The children in the control group (n:50) underwent routine mobilization of the clinic.
The data were collected with the "Child Follow-up Form", which was created to evaluate the child's demographic characteristics, physiological parameters, pain and fear.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| game group | Experimental | Device: gameChildren who accepted to participate in the game were taken to the playground with minimum two and maximum four people. After the children were introduced to each other, the rules of the game were explained. Between the children playing, dice were rolled to determine the starting order of the game. The player who scored the highest number had the right to start the game first. With the help of the stopwatch, the playing time was started, and the children played the game in accordance with the rules. For the child who first reached the square of the world, the time was stopped and recorded in the "Child Follow-up Form". The game was played with a maximum game duration of 15 minutes. In the same way, the times of the children who reached the world square in the second, third and fourth places were recorded on the "Follow-up Form". |
| control group | No intervention | –Children in the control group were allowed to walk for 15 minutes on a flat surface in the clinic accompanied by the researcher and their parents. As soon as the child came out of his room, the time was started with the help of a stopwatch. The time was stopped when the child went back to bed. The pain and fear scores of each child who completed the game and mobilization were evaluated separately and simultaneously by the child, parent and researcher with the help of the "Visual Analog Scale" and the "Child Fear Scale", and then the physiological parameter measurements were made by the researcher and the "Child Follow-up Form" was evaluated after the procedure. and data collection was terminated. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Being between 6-12 years old,
- Being open to communication and cooperation,
- No visual or hearing impairment,
- Appendectomy surgery,
- First mobilization after surgery.
Key exclusion criteria (2 listed)
- Having a mental or neurological disability,
- Children with hearing and vision impairment
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 |
|---|---|---|
| gameThe game is played with a maximum of four people. Beginning points are marked with blue, red, yellow and green colors, the game progress direction is The starting color for the player is determined with the help of arrows. Dice with the biggest number The child who throws starts the game first from the starting point that belongs to him. Play ground Each child who completes a circuit around him reads from his second point. it tries to go inwards (to the world square) in the direction it points. Equivalent to card check box The next child draws one of the face down cards. the instruction written on the back of the card. implements. Then he puts the card on the back of the other cards. Cards are reward (go forward), penalty (backward) git) cards. Coming second to the same frame during the game The child first starts the game from the starting point of the child in the square. First The child who manages to enter the world square wins the game. | Device | game group |
Primary outcome
The effect of environmental play on premobilization pain score of children
Time frame: 30 seconds
Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
The effect of environmental play on the postmobilization pain score of children
Time frame: 30 seconds
Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
The effect of environmental play on children's fear score before mobilization
Time frame: 30 seconds
Child Fear Scale (CFS) was used for determine fear score in this research. Scale got 0 to 4 points (0 (good) to 4 (bad)).
The effect of environmental play on children's fear score after mobilization
Time frame: 30 seconds
Child Fear Scale (CFS) was used for determine fear score in this research. Scale got 0 to 4 points (0 (good) to 4 (bad)).
The effect of environmental play on the pulse rate of children before mobilization
Time frame: 60 seconds
pulse rate
The effect of environmental play on the pulse rate of children after mobilization
Time frame: 60 seconds
pulse rate
The effect of environmental play on the blood pressure of children before mobilization
Time frame: 60 seconds
blood pressure
The effect of environmental play on the blood pressure of children after mobilization
Time frame: 60 seconds
blood pressure
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 2 Nov 2021.
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
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 game in people with Healthy, run by Okan University 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 6 inclusion and 2 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 2 Nov 2021. 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?
The effect of environmental play on premobilization pain score of children (time frame: 30 seconds). The study lists 8 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 2 Nov 2021.