Do Vacutainers With Animal Characters Reduce Fear and Anxiety?

Anxiety Clinical Trial

Official title:

The Effectiveness of Using Animal-Themed Vacutainers to Reduce Fear and Anxiety in Children During Bloodletting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06345911
• Other study ID #: NEU-49/899
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: March 2024
• Source: Burdur Mehmet Akif Ersoy University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 30, 2022
• Est. primary completion date: February 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Anxiety
• Anxiety Disorders
• Fear
• Pain, Procedural
• Procedural Pain

Intervention

Behavioral:
• 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. 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.

Locations

Country	Name	City	State
Turkey	Karaman Education and Research Hospital	Karaman

Sponsors (1)

Lead Sponsor	Collaborator
Burdur Mehmet Akif Ersoy University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.