Do Vacutainers With Animal Characters Reduce Fear and Anxiety?

NCT06345911 | Completed

• 1 other identifier: NEU-49/899
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using vacutainers of three different animal characters.

Conditions

Procedural Pain; Acute Pain; Fear; Anxiety

Keywords

Bloodletting; Animal Vacutainer; Procedural Pain; Fear; Distraction

Outcome Measures

Primary Outcomes (2)

• Children's Fear Scale

  CFS is used for measuring the child's anxiety level. CFS is a scale which makes an evaluation from 0 to 4 consisting of five facial expressions drawn to show expressions that vary from neutral expression (0=no anxiety) to scared face (4=severe anxiety).

  Through painful procedure completion, an average of 10 minutes

• Wong-Baker FACES Pain Rating Scale

  In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.

  Through painful procedure completion, an average of 10 minutes.

Study Arms (2)

Experimental group

EXPERIMENTAL

The animal characters were shown to the child before the bloodletting procedure. The child was asked to choose one of them and the one chosen by the child was attached to the vacutainer.

Behavioral: Experimental group

Control group

NO INTERVENTION

The child was subjected to routine bloodletting intervention with the vacutainer.

Interventions

Experimental group BEHAVIORAL

The animal characters were shown to the child before the bloodletting procedure. The child was asked to choose one of them and the one chosen by the child was attached to the vacutainer. The child and their parents were taken to the blood collection room. During the bloodletting procedure, the child was asked to focus on the animal character they had chosen.

Experimental group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child was selected by simple randomization.
• The child was between 4-7 years old.
• The child and parent were informed and their written consent was obtained prior to the procedure.
• The bloodletting procedure was performed by the same nurse.
• The child was given standard information before the bloodletting procedure.
• The needle used for the bloodletting procedure was of the same thickness.
• The child could evaluate the pain and fear scales.

You may not qualify if:

• The child was excluded from the study if they had the following criteria;
• The child had infection, skin integrity disturbance, and rash in the area where the procedure would be performed.
• The child had nerve damage in the previously treated area.
• The child's health status was critical and unstable.
• The child had developmental retardation that prevents them from responding to pain and fear scales.
• The child had taken any analgesic in the last 6 hours before the bloodletting procedure.
• The child did not want to participate.
• The child did not meet the selection criteria for the experimental and control groups.

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Karaman Education and Research Hospital

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural; Acute Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Selda Ateş Beşirik, PhD.

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: December 1, 2021
• Primary Completion: February 25, 2022
• Study Completion: March 30, 2022
• Last Updated: April 3, 2024

Record last verified: 2024-03

Locations

TU (1)