Clinical trial NCT05533827: The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical Procedure in Invasive Interventions
Official title: The Effect of Distraction Technique on Children's Pain, Anxiety and Fear of Medical
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior
Keywords: music
Kaleidoscope
virtual reality glasses
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 144
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain level
timeFrame: 5 minutes before intervention
measure: Pain level
timeFrame: 5 minutes after intervention
measure: Anxiety level
timeFrame: 5 minutes before intervention
measure: Anxiety level
timeFrame: 5 minutes after intervention
measure: Fear of medical procedures
timeFrame: 5 minutes before intervention
measure: Fear of medical procedures
timeFrame: 5 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Bandırma
country: Turkey
facility: Banıdrma Onyedi Eylul University
state: Balıkesir
Study officials:
References: