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

NCT ID: NCT05758584

Last Updated: 2023-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group 1

Vibrating tourniquet group

Group Type EXPERIMENTAL

Intervention

Intervention Type OTHER

Vibrating tourniquet

Group 2

Distraction cards group

Group Type EXPERIMENTAL

Distraction card

Intervention Type OTHER

Distraction card

Group 3

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention

Vibrating tourniquet

Intervention Type OTHER

Distraction card

Distraction card

Intervention Type OTHER

Other Intervention Names

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Vibrating tourniquet

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Hümeyra Erdem

Register Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Health Sciences Turkey

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 29728296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28712986 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29559294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33711642 (View on PubMed)

Other Identifiers

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pain_fear_anxiety...///

Identifier Type: -

Identifier Source: org_study_id

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