Effect Of Game-Based Breathing Exercise On Pain, Fear, And Anxiety In Children During Venipuncture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-12
SponsorUludag University
About this trial
Venipuncture is one of the most common invasive procedures in children and is often associated with significant pain, fear, and anxiety.This randomized controlled study will aim to evaluate the effects of a video game-based breathing exercise intervention on pain, fear, and anxiety levels in children aged 7-12 years undergoing routine venipuncture. While the intervention group will receive a video game-based breathing exercise using the BREATHING+ system in addition to standard care, the control group will receive routine venipuncture procedures only. The study population will consist of children aged 7-12 years who meet the inclusion criteria and whose parents/legal guardians provide informed consent. Participants will be randomly assigned to intervention and control groups. Pain, fear, and anxiety levels will be assessed at three time points: before the procedure, during the procedure, and immediately after the procedure. Data will be collected using the Visual Analog Scale (VAS), Children's Anxiety Scale-State (CAS-S), and Children's Fear Scale (CFS), along with a structured questionnaire form. All assessments will be conducted at the predefined time points.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• Being between 7-12 years of age
Undergoing a venipuncture procedure
Able to understand and speak Turkish
Having written informed consent from the parent/legal guardian and age-appropriate verbal assent from the child
Disqualifiers
• History of epilepsy or recurrent seizures
Presence of severe congenital chronic disease, congenital anomaly, or behavioral disorder
Presence of visual or hearing impairment, or cognitive/developmental delay
Use of psychoactive medications
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention Group (Video Game-Based Breathing Exercise During Venipuncture)
Other interventionChildren in the intervention group will receive a video game-based breathing exercise in addition to standard venipuncture.
Video Game-Based Breathing Exercise Device
DeviceThe system consists of a head-mounted headset unit and a mouthpiece sensor that detects expiration. It operates the game through a mouthpiece that senses the child's exhalation via the oral route and does not involve any medication, electrical stimulation, or invasive procedures.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control Group (Standard Venipuncture Procedure)No intervention 0 interventions
Group B: Intervention Group (Video Game-Based Breathing Exercise During Venipuncture)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Visual Analog Scale (VAS)
It consists of a 10 cm long straight line. The point "0" indicates "no pain" and the point "10" indicates "unbearable pain". It can be used in children aged 7 years and older. The child is asked to mark the point that represents the severity of their pain. It has been stated that this scale is more sensitive and reliable than other unidimensional scales. The VAS has been found to be a reliable scale in the evaluation of acute pain.
Time frame
1 minute before the intervention, during the intervention, and immediately after the intervention2
Children's Anxiety Scale-State (CAS-S)
The Children's Anxiety Scale-State (CAS-S) was adapted into Turkish by Özalp Gerçeker et al. in 2018, and its validity and reliability were established for children aged 4-10 years (validity index: 1.00). This scale will be used to assess children's state anxiety during venipuncture. It consists of a thermometer-like visual format in which children indicate their anxiety level by marking a point on the scale. Children who are not cognitively appropriate will be excluded from the assessment. Scores range from 0 to 10, evaluated in 0.5-point increments and rounded to the nearest whole number.
Time frame
1 minute before the intervention, and immediately after the intervention3
Child Fear Scale (CFS)
The Children's Anxiety Scale is used to assess the child's level of anxiety. It is a single-item scale consisting of five gender-neutral facial expressions ranging from a neutral face (0 = no anxiety) to a fearful face (4 = severe anxiety), scored between 0 and 4.
Time frame
1 minute before the intervention, during the intervention, and immediately after the interventionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Uludag University
Lead sponsor
Fenerbahce University
Sponsor institution
Source ClinicalTrials.gov
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