Environmental Game After Appendicitis Surgery

Sponsor

Okan University (Other)

Overall Status

Completed

CT.gov ID

NCT05104021

Collaborator

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

8.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: game	N/A

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

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Nov 1, 2018

Actual Primary Completion Date :

May 1, 2019

Actual Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: game group 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".	Device: game 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.
No Intervention: control group 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.

Arm

Intervention/Treatment

Experimental: game group

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".

Device: game

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.

No Intervention: control group

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.

Outcome Measures

Primary Outcome Measures

The effect of environmental play on premobilization pain score of children [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 [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 [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 [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 [60 seconds]
pulse rate
The effect of environmental play on the pulse rate of children after mobilization [60 seconds]
pulse rate
The effect of environmental play on the blood pressure of children before mobilization [60 seconds]
blood pressure
The effect of environmental play on the blood pressure of children after mobilization [60 seconds]
blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul okan university	Tuzla	Istanbul	Turkey	34959

Sponsors and Collaborators

Okan University
Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Melike Yilmaz Akdag, Principal Investigator, RN, MSc, Okan University

ClinicalTrials.gov Identifier:

NCT05104021

Other Study ID Numbers:

2018.06.01

First Posted:

Nov 2, 2021

Last Update Posted:

Nov 2, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Melike Yilmaz Akdag, Principal Investigator, RN, MSc, Okan University

Additional relevant MeSH terms:

Appendicitis

Study Results

No Results Posted as of Nov 2, 2021