The Pain and Anxiety in Children With Intramuscular Injection

Not Applicable

Completed

• Conditions: Intramuscular Myxoma
• Interventions: Behavioral: Stress Ball; Behavioral: Distraction Card

• Registration Number: NCT05444634
• Lead Sponsor: Ataturk University

Brief Summary

This study was planned as a randomized controlled experimental study to determine the effect of distraction cards and stress ball on pain and anxiety in children with intramuscular injection.

Detailed Description

Pharmacological and non-pharmacological methods are used in the management of pain and anxiety in children. Non-pharmacological methods are noninvasive, inexpensive, have no side effects and are independent functions of the nurse.This study was planned as a randomized controlled experimental study to determine the effect of distraction cards and stress ball on pain and anxiety in children with intramuscular injection. The study was conducted between May 2022 and August 2022. It will be done with children aged 3-6 years who come to the emergency unit of the State Hospital, who are given intramuscular injection.

"Descriptive Information Form", "Wong Baker Faces Pain Rating Scale", "Venham Anxiety Rating Picture Scale" will be used in data collection.

Study Timeline

• Study First Submitted: 2022-04-29
• Study Start: 2022-05-01
• Study First Submitted QC: 2022-07-02
• Study First Posted: 2022-07-06
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 3-6 years old
• Intramuscular administration of ondansetron hcl active ingredient drug
• Mentally and physically handicapped
• Does not have a disease that causes chronic pain
• Open to communication
• Fluent in Turkish

Exclusion Criteria

• Children of parents who did not give written consent
• Children who do not give verbal consent appropriate to the child's developmental level

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stress Ball	Stress Ball	The child will be informed about the stress ball and asked to play continuously
distraction card	Distraction Card	Immediately before the procedure, the child will be asked questions about the distraction cards. Questions about the cards will continue to be asked immediately after the intramuscular injection is finished.

Primary Outcome Measures

Name	Time	Method
Pain, acute	12 week	Wong Baker Faces Pain Rating Scale: This scale was developed by Donna Wong and Connie Morain Baker in 1981 and later revised in 1983.; The scale is suitable for describing the pain status of children aged 3-18 years.; Children can express many pain areas and their severity with this scale. There are 6 facial expressions in the scale. The scores of "0", "2", "4", "6", "8", "10" were indicated for each facial expression, respectively.; Facial expressions are given points with the lowest "0" and the highest "10". A score of "0" was defined as no pain, while a score of "10" was defined as unbearable pain.
Anxiety, spitefulness	12 week	Venham Anxiety Rating Picture Scale: The scale was developed by Larry L. Venham and Elise Gaulin Kremer in 1979. The scale is used to determine the anxiety status of children over 3 years old. There are 8 cards in the scale and two pictures on each card. Cards 1 to 8 are shown to the child in turn.; Of the pictures, the anxious picture is given 1 point, while the non-anxious picture is given 0 points.; The lowest is 0 points, while the highest is 8 points. In the 0 to 8 scoring system, the higher the score, the higher the anxiety rate.

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, Erzuum, Turkey