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Environmental Game After Appendicitis Surgery

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
game
Sponsored by
Okan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy focused on measuring Pain, Fear, Pediatric surgery, Game, Appendicitis

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Having a mental or neurological disability,
  • Children with hearing and vision impairment

Sites / Locations

  • Istanbul okan university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

game group

control group

Arm Description

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".

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.

Outcomes

Primary Outcome Measures

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)).
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)).
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)).
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)).
The effect of environmental play on the pulse rate of children before mobilization
pulse rate
The effect of environmental play on the pulse rate of children after mobilization
pulse rate
The effect of environmental play on the blood pressure of children before mobilization
blood pressure
The effect of environmental play on the blood pressure of children after mobilization
blood pressure

Secondary Outcome Measures

Full Information

First Posted
August 19, 2021
Last Updated
October 22, 2021
Sponsor
Okan University
Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05104021
Brief Title
Environmental Game After Appendicitis Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University
Collaborators
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Pain, Fear, Pediatric surgery, Game, Appendicitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
game group
Arm Type
Experimental
Arm Description
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".
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
game
Intervention Description
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.
Primary Outcome Measure Information:
Title
The effect of environmental play on premobilization pain score of children
Description
Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
Time Frame
30 seconds
Title
The effect of environmental play on the postmobilization pain score of children
Description
Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
Time Frame
30 seconds
Title
The effect of environmental play on children's fear score before mobilization
Description
Child Fear Scale (CFS) was used for determine fear score in this research. Scale got 0 to 4 points (0 (good) to 4 (bad)).
Time Frame
30 seconds
Title
The effect of environmental play on children's fear score after mobilization
Description
Child Fear Scale (CFS) was used for determine fear score in this research. Scale got 0 to 4 points (0 (good) to 4 (bad)).
Time Frame
30 seconds
Title
The effect of environmental play on the pulse rate of children before mobilization
Description
pulse rate
Time Frame
60 seconds
Title
The effect of environmental play on the pulse rate of children after mobilization
Description
pulse rate
Time Frame
60 seconds
Title
The effect of environmental play on the blood pressure of children before mobilization
Description
blood pressure
Time Frame
60 seconds
Title
The effect of environmental play on the blood pressure of children after mobilization
Description
blood pressure
Time Frame
60 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Having a mental or neurological disability, Children with hearing and vision impairment
Facility Information:
Facility Name
Istanbul okan university
City
Tuzla
State/Province
Istanbul
ZIP/Postal Code
34959
Country
Turkey

12. IPD Sharing Statement

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Environmental Game After Appendicitis Surgery

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