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Completed

NCT Number: NCT05444634

The 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.

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Key information

Conditions

Intramuscular Myxoma Acute Pain Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, Erzuum, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain, acute

    Time frame: 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.

  2. Anxiety, spitefulness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Collaborators

  • MSc Merve Eroğlu

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2022
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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