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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05444634
Enrollment
90
Registered
2022-07-06
Start date
2022-05-01
Completion date
2022-09-30
Last updated
2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intramuscular Myxoma

Keywords

Children, Pain, Acute, Anxiety

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.

Interventions

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.

BEHAVIORALStress 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.

Sponsors

MSc Merve Eroğlu
CollaboratorUNKNOWN
Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain, acute12 weekWong 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, spitefulness12 weekVenham 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026