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

NCT05533827 | Completed

• 1 other identifier: BandirmaOnyediEylulUU
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Keywords

music; Kaleidoscope; virtual reality glasses

Outcome Measures

Primary Outcomes (6)

• Pain level

  Pain level

  5 minutes before intervention

• Pain level

  Pain level

  5 minutes after intervention

• Anxiety level

  Anxiety level

  5 minutes before intervention

• Anxiety level

  Anxiety level

  5 minutes after intervention

• Fear of medical procedures

  Fear of medical procedures

  5 minutes before intervention

• Fear of medical procedures

  Fear of medical procedures

  5 minutes after intervention

Study Arms (4)

Kaleidoscope

EXPERIMENTAL

Kaleidoscope

Other: Kaleidoscope; Other: Music; Other: Virtual reality glasses

Music

EXPERIMENTAL

Music listening

Other: Kaleidoscope; Other: Music; Other: Virtual reality glasses

Virtual reality glasses

EXPERIMENTAL

Virtual reality glasses

Other: Kaleidoscope; Other: Music; Other: Virtual reality glasses

Control

NO INTERVENTION

Control

Interventions

Kaleidoscope OTHER

Kaleidoscope

Kaleidoscope; Music; Virtual reality glasses

Music OTHER

Music

Kaleidoscope; Music; Virtual reality glasses

Virtual reality glasses OTHER

Virtual reality glasses

Kaleidoscope; Music; Virtual reality glasses

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bandırma Onyedi Eylül University: lead

Study Sites (1)

Banıdrma Onyedi Eylul University

Bandırma, Balıkesir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Child Behavior

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: September 9, 2022
• Study Start: June 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 9, 2022

Record last verified: 2022-09

Locations

TU (1)