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Do Vacutainers With Animal Characters Reduce Fear and Anxiety?

B

Burdur Mehmet Akif Ersoy University

Status

Completed

Conditions

Fear
Anxiety
Acute Pain
Procedural Pain

Treatments

Behavioral: Experimental group

Study type

Interventional

Funder types

Other

Identifiers

NCT06345911
NEU-49/899

Details and patient eligibility

About

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.

Full 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.

Enrollment

180 patients

Sex

All

Ages

4 to 7 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 2 patient groups

Experimental group
Experimental group
Description:
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.
Treatment:
Behavioral: Experimental group
Control group
No Intervention group
Description:
The child was subjected to routine bloodletting intervention with the vacutainer.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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