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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05104021
Other study ID # 2018.06.01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2018
Est. completion date May 1, 2019

Study information

Verified date October 2021
Source Okan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Istanbul okan university Tuzla Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Okan University Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)). 30 seconds
Primary 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)). 30 seconds
Primary 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)). 30 seconds
Primary 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)). 30 seconds
Primary The effect of environmental play on the pulse rate of children before mobilization pulse rate 60 seconds
Primary The effect of environmental play on the pulse rate of children after mobilization pulse rate 60 seconds
Primary The effect of environmental play on the blood pressure of children before mobilization blood pressure 60 seconds
Primary The effect of environmental play on the blood pressure of children after mobilization blood pressure 60 seconds
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