The Pain and Anxiety in Children With Intramuscular Injection

NCT05444634 | Completed

• 1 other identifier: B.30.2.ATA.O.01.00/265
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Intramuscular Myxoma

Keywords

Children; Pain, Acute; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

distraction card

EXPERIMENTAL

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

Stress Ball

EXPERIMENTAL

The child will be informed about the stress ball and asked to play continuously

Behavioral: Stress Ball

Control

NO INTERVENTION

Interventions

Distraction Card BEHAVIORAL

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.

distraction card

Stress Ball BEHAVIORAL

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.

Stress Ball

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead
• MSc Merve Eroğlu: collaborator

Study Sites (1)

Ataturk University

Erzurum, Erzuum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: July 6, 2022
• Study Start: May 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)