Clinical trial NCT05758584: Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety in Children
Official title: Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety Levels During Phlebotomy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: pain
anxiety
children
nurse
phlebotomy
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled study
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: change on pain intensity as measured by Visual Analog Scale
timeFrame: "5-10 minutes before procedure", "during procedure" and "5 minutes after" blood collection process
Secondary outcomes:
measure: Score change on state anxiety level as measured by Child Anxiety Scale State Scale (ÇAS-D)
timeFrame: "5-10 minutes before procedure" and "5 minutes after procedure" blood collection process
measure: Score change on fear level as measured by Children's Fear Scale
timeFrame: "5-10 minutes before procedure" and "5 minutes after procedure" blood collection process
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences Turkey
Study officials:
References:
citation: Bergomi P, Scudeller L, Pintaldi S, Dal Molin A. Efficacy of Non-pharmacological Methods of Pain Management in Children Undergoing Venipuncture in a Pediatric Outpatient Clinic: A Randomized Controlled Trial of Audiovisual Distraction and External Cold and Vibration. J Pediatr Nurs. 2018 Sep-Oct;42:e66-e72. doi: 10.1016/j.pedn.2018.04.011. Epub 2018 May 1.
citation: Bukola IM, Paula D. The Effectiveness of Distraction as Procedural Pain Management Technique in Pediatric Oncology Patients: A Meta-analysis and Systematic Review. J Pain Symptom Manage. 2017 Oct;54(4):589-600.e1. doi: 10.1016/j.jpainsymman.2017.07.006. Epub 2017 Jul 14.
citation: Gerceker GO, Binay S, Bilsin E, Kahraman A, Yilmaz HB. Effects of Virtual Reality and External Cold and Vibration on Pain in 7- to 12-Year-Old Children During Phlebotomy: A Randomized Controlled Trial. J Perianesth Nurs. 2018 Dec;33(6):981-989. doi: 10.1016/j.jopan.2017.12.010. Epub 2018 Mar 17.
citation: Diaz-Rodriguez M, Alcantara-Rubio L, Aguilar-Garcia D, Perez-Munoz C, Carretero-Bravo J, Puertas-Cristobal E. The Effect of Play on Pain and Anxiety in Children in the Field of Nursing: A Systematic Review. J Pediatr Nurs. 2021 Nov-Dec;61:15-22. doi: 10.1016/j.pedn.2021.02.022. Epub 2021 Mar 10.