Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety Levels During Phlebotomy in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- change on pain intensity as measured by Visual Analog Scale
Study Overview
Brief Summary
The aim of the study was to observe the effect of the use of vibrating tourniquet and distraction card on the pain, fear and anxiety levels felt during the blood collection process in children. The study was conducted between July 2021 and March 2022 as a randomized controlled study with totally 120 children in three groups. The 'Child and Parent Identification Form' was used for socio-demographic data about the child and the parent before phlebotomy. The 'Visual Analog Scale (VAS)', 'Child Fear Scale (CFS)' and 'Child Anxiety Scale-State Scale (ÇAS-D)' were used before, during and after the phlebotomy. Vibrating Tourniquet Group (intervention group 1) consists of a total of 40 children. Distraction Cards Group (intervention group 2) consists of a total of 40 children. Control group consists of a total of 40 children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The child is between the ages of 6-10,
- •The child has no pain just before the procedure,
- •The child has not taken any analgesic-effective medication in the last 6 hours,
- •The child does not have a hearing problem,
- •The child and the parent can speak and understand Turkish
- •The child has a sufficient level of mental development to understand speech -Parent and child are willing to participate in the research.
Exclusion Criteria
- •Children who cannot be successfully drawn in the first application
- •Children with oncological disease, epilepsy, migraine, or vestibular disorder.
Arms & Interventions
Group 1
Vibrating tourniquet group
Intervention: Intervention (Other)
Group 2
Distraction cards group
Intervention: Distraction card (Other)
Group 3
Control group
Outcomes
Primary Outcomes
change on pain intensity as measured by Visual Analog Scale
Time Frame: "5-10 minutes before procedure", "during procedure" and "5 minutes after" blood collection process
It is a 10 cm or 100 mm long horizontal or vertical line with anchor statements "no pain or pain at its least" at the left-most end and "unbearable pain or worst pain imaginable" at the right-most end. The VAS score is determined by measuring (in cm) the distance of the mark from the left end of the line.
Secondary Outcomes
- Score change on state anxiety level as measured by Child Anxiety Scale State Scale (ÇAS-D)("5-10 minutes before procedure" and "5 minutes after procedure" blood collection process)
- Score change on fear level as measured by Children's Fear Scale("5-10 minutes before procedure" and "5 minutes after procedure" blood collection process)
Investigators
Hümeyra Erdem
Register Nurse
Saglik Bilimleri Universitesi