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

NCT ID: NCT05533827

Last Updated: 2022-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2021-12-01

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.

Conditions

Child Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Kaleidoscope

Kaleidoscope

Group Type: EXPERIMENTAL

Kaleidoscope

Intervention Type: OTHER

Kaleidoscope

Music

Intervention Type: OTHER

Music

Virtual reality glasses

Intervention Type: OTHER

Virtual reality glasses

Music

Music listening

Group Type: EXPERIMENTAL

Kaleidoscope

Intervention Type: OTHER

Kaleidoscope

Music

Intervention Type: OTHER

Music

Virtual reality glasses

Intervention Type: OTHER

Virtual reality glasses

Virtual reality glasses

Virtual reality glasses

Group Type: EXPERIMENTAL

Kaleidoscope

Intervention Type: OTHER

Kaleidoscope

Music

Intervention Type: OTHER

Music

Virtual reality glasses

Intervention Type: OTHER

Virtual reality glasses

Control

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Kaleidoscope

Kaleidoscope

Intervention Type: OTHER

Music

Music

Intervention Type: OTHER

Virtual reality glasses

Virtual reality glasses

Intervention Type: OTHER

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bandırma Onyedi Eylül University

OTHER

Sponsor Role: lead

Responsible Party

Nursen Goktas

Registered Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Banıdrma Onyedi Eylul University

Bandırma, Balıkesir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BandirmaOnyediEylulUU

Identifier Type: -

Identifier Source: org_study_id