The Pain and Anxiety in Children With Intramuscular Injection

The Effect of Distraction Cards and Stress Ball on Pain and Anxiety in Children With Intramuscular Injection

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.

Study Overview

• Status: Completed
• Conditions: Intramuscular Myxoma
• Intervention / Treatment: Behavioral: Distraction Card; Behavioral: Stress Ball

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzuum
    • Erzurum, Erzuum, Turkey, 25240
      • Ataturk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: 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.	Behavioral: Distraction Card; Suitable for children over 3 years old. 1 set of 32 pieces of thick cardboard cards It has been prepared by child development experts in line with pedagogical principles. Size: 13cm x 8cm, Each card illustrates the skills and actions the children do.
Experimental: Stress Ball; The child will be informed about the stress ball and asked to play continuously	Behavioral: Stress Ball; Brain Shaped Stress Ball, White rope in the form of mesh around the inner silicone Size: Approx 2.4 inches (6 cm), Color: Colorful, When squeezed, the silicone structure comes out in the mesh spaces and turns into a bunch of grapes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, acute	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.	12 week
Anxiety, spitefulness	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.	12 week

Collaborators and Investigators

• Sponsor: Ataturk University
• Collaborators: MSc Merve Eroğlu

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; Children; Pain, Acute
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Myxoma
• Other Study ID Numbers: B.30.2.ATA.O.01.00/265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No