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

Child Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05533827
• Other study ID #: BandirmaOnyediEylulUU
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: September 2022
• Source: Bandirma Onyedi Eylül University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior

Intervention

Other:
• Kaleidoscope
Kaleidoscope
• Music
Music
• Virtual reality glasses
Virtual reality glasses

Locations

Country	Name	City	State
Turkey	Banidrma Onyedi Eylul University	Bandirma	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level	Pain level	5 minutes before intervention
Primary	Pain level	Pain level	5 minutes after intervention
Primary	Anxiety level	Anxiety level	5 minutes before intervention
Primary	Anxiety level	Anxiety level	5 minutes after intervention
Primary	Fear of medical procedures	Fear of medical procedures	5 minutes before intervention
Primary	Fear of medical procedures	Fear of medical procedures	5 minutes after intervention