NCT05104021

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

August 19, 2021

Last Update Submit

October 22, 2021

Conditions

Keywords

PainFearPediatric surgeryGameAppendicitis

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • The effect of environmental play on the pulse rate of children before mobilization

    pulse rate

    60 seconds

  • The effect of environmental play on the pulse rate of children after mobilization

    pulse rate

    60 seconds

  • The effect of environmental play on the blood pressure of children before mobilization

    blood pressure

    60 seconds

  • The effect of environmental play on the blood pressure of children after mobilization

    blood pressure

    60 seconds

Study Arms (2)

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".

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.

Interventions

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.

game group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul okan university

Tuzla, Istanbul, 34959, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAppendicitis

Interventions

Games, Experimental

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsIntraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, RN, MSc

Study Record Dates

First Submitted

August 19, 2021

First Posted

November 2, 2021

Study Start

November 1, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

November 2, 2021

Record last verified: 2021-10

Locations