Do Vacutainers With Animal Characters Reduce Fear and Anxiety?
The Effectiveness of Using Animal-Themed Vacutainers to Reduce Fear and Anxiety in Children During Bloodletting
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. In light of this information, this study aimed to compare the effects of vacutainers of three different animal characters on fear, anxiety, and pain in children during bloodletting.
The study is a prospective, randomized and controlled trial.Children aged 4 to 7 years who required blood draw were divided into three groups; two groups: experimental and control groups. Animal characters (butterfly, peacock and rabbit) chosen by children in the experimental group was attached to the vacutainer, and then their blood was drawn. The data were obtained by face-to-face interviews with the child, parent and observer before and after the procedure. Children's pain and fear/anxiety levels were evaluated using the Children's Fear Scale and theWong-Baker FACES Pain Scale, respectively.
The study population consisted of children aged 4 to 7 years who presented to the children's blood draw room of the hospital.
Sample of the study consisted of a total of 1800 children who met the sample selection criteria and were selected via randomization method.
Data were collected using the Interview and Observation Form, Children's Fear Scale, and Wong-Baker FACES Pain Rating Scale.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Karaman, Turkey
- Karaman education and research hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Experimental group
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.
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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.
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No Intervention: Control group
The child was subjected to routine bloodletting intervention with the vacutainer.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Children's Fear Scale
Time Frame: Through painful procedure completion, an average of 10 minutes
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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).
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Through painful procedure completion, an average of 10 minutes
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Wong-Baker FACES Pain Rating Scale
Time Frame: Through painful procedure completion, an average of 10 minutes.
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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.
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Through painful procedure completion, an average of 10 minutes.
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Collaborators and Investigators
Investigators
- Principal Investigator: Selda Ateş Beşirik, PhD., Burdur Mehmet Akif Ersoy University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEU-49/899
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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