Clinical trial NCT06345911: Do Vacutainers With Animal Characters Reduce Fear and Anxiety?
Official title: The Effectiveness of Using Animal-Themed Vacutainers to Reduce Fear and Anxiety in Children During Bloodletting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Acute Pain
Fear
Anxiety
Keywords: Bloodletting
Animal Vacutainer
Procedural Pain
Fear
Distraction
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 180
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Children's Fear Scale
timeFrame: Through painful procedure completion, an average of 10 minutes
measure: Wong-Baker FACES Pain Rating Scale
timeFrame: Through painful procedure completion, an average of 10 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Education and Research Hospital
Study officials:
affiliation: Burdur Mehmet Akif Ersoy University
name: Selda Ateş Beşirik, PhD.
role: PRINCIPAL_INVESTIGATOR
References: