RecruitingNot ApplicableNCT06354608

The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children

The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children: A Randomised Controlled Study


Sponsor

University of Yalova

Enrollment

120 participants

Start Date

Oct 25, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear.


Eligibility

Min Age: 4 YearsMax Age: 6 Years

Inclusion Criteria11

  • The child and family agree to participate in the research,
  • The child is between the ages of 4-6,
  • The child does not have a chronic and mental health problem,
  • Absence of visual, auditory problems or mental retardation at a level that can fill the scales,
  • No history of sedative, analgesic or narcotic substance use within 24 hours before admission,
  • Absence of a disease causing chronic pain,
  • Not having a febrile illness at the time of application,
  • Being treated in the pediatric emergency unıt at the time of the study,
  • Intramuscular injection in the vastus lateralis region,
  • Ondansetron will be injected intramuscularly in the vastus lateralis area, as directed by the doctor.
  • Performing the operation at once.

Exclusion Criteria6

  • The child and family's refusal to participate in the research,
  • Having a visual and auditory problem
  • The child is less than 4 years old or older than 6 years old
  • The child has a chronic and mental health problem
  • The child experiences pain,
  • To have taken analgesic medication in the last 6 hours.

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Interventions

BEHAVIORALAudio Book Group

Audiobook will be applied during the entire IM injection procedure and until the end of the procedure. After the procedure is over, the children will be taken to the waiting area. After being allowed to rest for 1-2 minutes, the child will be asked to rate their level of pain and fear during the procedure. A parent who is with the child and observes the child's behavior, and the same nurse who is independent from the study, will independently rate the child's pain and fear level during the procedure.

DEVICELocal Vibration Group

In the local vibration group, IM injection will be performed with a vibrating massage device. After the procedure is finished, the children will be taken to the waiting section. After being allowed to rest for 1-2 minutes, the child will be asked to rate their level of pain and fear during the procedure. A parent who is with the child and observes the child's behavior and the same nurse who is independent from the study will independently rate the pain and fear level of the child during the procedure.


Locations(1)

University of Yalova

Yalova, Turkey (Türkiye)

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NCT06354608


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