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

Not Applicable

Completed

• Conditions: Child Behavior
• Interventions: Other: Kaleidoscope; Other: Music; Other: Virtual reality glasses

• Registration Number: NCT05533827
• Lead Sponsor: Bandırma Onyedi Eylül University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-11-01
• Study Completion: 2021-12-01
• Study First Submitted: 2022-08-17
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-05
• Last Update Submitted: 2022-09-05
• Study First Posted: 2022-09-09
• Last Update Posted: 2022-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality glasses	Music	Virtual reality glasses
Kaleidoscope	Virtual reality glasses	Kaleidoscope
Music	Music	Music listening
Kaleidoscope	Kaleidoscope	Kaleidoscope
Music	Virtual reality glasses	Music listening
Music	Kaleidoscope	Music listening
Virtual reality glasses	Virtual reality glasses	Virtual reality glasses
Kaleidoscope	Music	Kaleidoscope
Virtual reality glasses	Kaleidoscope	Virtual reality glasses

Primary Outcome Measures

Name	Time	Method
Fear of medical procedures	5 minutes after intervention	Fear of medical procedures
Pain level	5 minutes after intervention	Pain level
Anxiety level	5 minutes after intervention	Anxiety level

Trial Locations

Locations (1)

Banıdrma Onyedi Eylul University; 🇹🇷 Bandırma, Balıkesir, Turkey