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Completed

NCT Number: NCT05533827

The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical Procedure in Invasive Interventions

This study was conducted on the effects of visual and/or auditory distraction techniques applied to children aged 7-12 years who applied to Çanakkale Mehmet Akif Ersoy State Hospital Gynecology and Pediatric Emergency Service during invasive procedures (blood sampling, intravenous access or intramuscular injection in the deltoid region). Kaleidoscope, music concert, virtual reality glasses) is a randomized controlled experimental study to determine the effect of children on pain, anxiety and fear of medical procedures.

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Key information

Conditions

Child Behavior Behavior

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banıdrma Onyedi Eylul University

Bandırma, Balıkesir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The child is between the ages of 7 and 12
  • Admission of the child to the pediatric emergency service for diagnosis and treatment
  • The child's general condition is stable
  • Deciding on one of the interventions such as blood collection, vascular access, deltoid region intramuscular injection after the examination, and the absence of any other invasive intervention planning
  • The fact that the invasive intervention was performed in one go
  • The child does not have vision and hearing problems
  • The child has no pain (due to the disease, drug side effects, distension)
  • The child does not have a chronic disease (kidney, diabetes, etc.) that will require frequent invasive procedures.
  • The child's mental development level to be able to answer the questions asked
  • The child and parent speak and understand Turkish comfortably
  • The children and their parents are willing to participate in the research.
  • Parents give written consent

Exclusion criteria

  • The child has a history of epilepsy, vertigo and neurological disease
  • Having a history of fainting during blood draw
  • Having a disease that causes chronic pain
  • Wearing glasses or hearing aids
  • Complication development during invasive intervention (allergy, syncope, etc.)
  • If the child is in danger of life and is taken to the very urgent patient examination room (resuscitation room)
  • Deciding that the child is a forensic case after the examination

Treatment and study plan

kaleidoscope

Other

Kaleidoscope

Music

Other

Music

Virtual reality glasses

Other

Virtual reality glasses

Primary outcomes

  1. Pain level

    Time frame: 5 minutes before intervention

    Pain level

  2. Pain level

    Time frame: 5 minutes after intervention

    Pain level

  3. Anxiety level

    Time frame: 5 minutes before intervention

    Anxiety level

  4. Anxiety level

    Time frame: 5 minutes after intervention

    Anxiety level

  5. Fear of medical procedures

    Time frame: 5 minutes before intervention

    Fear of medical procedures

  6. Fear of medical procedures

    Time frame: 5 minutes after intervention

    Fear of medical procedures

Sponsors and collaborators

Lead sponsor

Bandırma Onyedi Eylül University

Other

Registry information

Official study title

The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2022
Registry last updated
Sep 9, 2022

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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