Do Vacutainers With Animal Characters Reduce Fear and Anxiety?

NCT ID: NCT06345911

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-03-30

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.

Conditions

Procedural Pain; Acute Pain; Fear; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Experimental group

Intervention Type: 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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Burdur Mehmet Akif Ersoy University

OTHER

Sponsor Role: lead

Responsible Party

Selda Ateş Beşirik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selda Ateş Beşirik, PhD.

Role: PRINCIPAL_INVESTIGATOR

Burdur Mehmet Akif Ersoy University

Locations

Karaman Education and Research Hospital

Karaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

NEU-49/899

Identifier Type: -

Identifier Source: org_study_id