Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety in Children

NCT05758584 | Completed

• 1 other identifier: pain_fear_anxiety...///
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety

Keywords

pain; anxiety; children; nurse; phlebotomy

Outcome Measures

Primary Outcomes (1)

• change on pain intensity as measured by Visual Analog Scale

  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.

  "5-10 minutes before procedure", "during procedure" and "5 minutes after" blood collection process

Secondary Outcomes (2)

• 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

Study Arms (3)

Group 1

EXPERIMENTAL

Vibrating tourniquet group

Other: Intervention

Group 2

EXPERIMENTAL

Distraction cards group

Other: Distraction card

Group 3

NO INTERVENTION

Control group

Interventions

Intervention OTHER

Vibrating tourniquet

Also known as: Vibrating tourniquet

Group 1

Distraction card OTHER

Distraction card

Group 2

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children who cannot be successfully drawn in the first application
• Children with oncological disease, epilepsy, migraine, or vestibular disorder.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences Turkey

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 29728296 BACKGROUND

• 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.

  PMID: 28712986 BACKGROUND

• 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.

  PMID: 29559294 BACKGROUND

• 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.

  PMID: 33711642 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Register Nurse

Model Details: randomized controlled study

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: March 7, 2023
• Study Start: July 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 7, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)