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Clinical Trials/NCT05064657
NCT05064657
Completed
Not Applicable

The Effect of Two Different Applications on Reducing Pain and Fear During Draw Blood From Children

Selcuk University1 site in 1 country111 target enrollmentJuly 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Procedural
Sponsor
Selcuk University
Enrollment
111
Locations
1
Primary Endpoint
Children's Fear Scale mean score
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study was conducted to evaluate the effects of two different distraction methods on reducing pain and fear during blood collection from children.

The study was conducted between January 2020 and May 2021.

Detailed Description

The study was a pretest-posttest, parallel group randomized controlled experimental design. H0: The pain and fear mean scores of the intervention group, in which the distraction method (ball squeezing and blowing bubbles) was applied during the blood collection process, was not different from the control group. The study was carried out with the participation of 111 children aged 6-12 years and their parents, who underwent blood collection in the emergency department of a state hospital. Children were randomly assigned to blowing bubbles (n:37), ball squeezing (n:37) and control (n:37) groups. Bubble blowing and ball squeezing methods were used to distract attention during the blood collection process. Data were collected with Child and Family Information Form, Wong Baker Faces Pain Scale, Child Fear Scale. Pretest and posttest measurements were recorded separately by the child, parent and researcher. Descriptive statistics, Chi-square test, one-way analysis of variance, Tamhane's T2 test, t test for dependent groups were used in the analysis of the data. The statistical significance of the results was taken as p\<0,05

Registry
clinicaltrials.gov
Start Date
July 20, 2020
End Date
October 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fatma Taş Arslan

Professor

Selcuk University

Eligibility Criteria

Inclusion Criteria

  • Being between the ages of 6-12
  • The child's willingness to voluntarily participate in the study
  • Parent's willingness to participate in the study voluntarily
  • Parent and child can speak Turkish

Exclusion Criteria

  • The child has a disease that causes chronic pain
  • The child has a hearing or visual impairment
  • The child has a mental or neurological disability
  • The child has used drugs that will create an analgesic effect in the last 24 hours before the application

Outcomes

Primary Outcomes

Children's Fear Scale mean score

Time Frame: First ten minute

Children's Fear Scale is a scale of 0-4 showing five faces ranging from a neutral expression (0 = no concern) to the feared face (4 = severe anxiety). A score of 0 indicates no fear and a score of 4 indicates extremely fearful. Defines the change of fear level before and after during the blood collection.

Wong Baker Pain Faces Scale mean score

Time Frame: First ten minute

Wong-Baker Pain Faces Scale is widely used with people ages three and older, not limited to children. This self-assessment tool must be understood by the patient, so they are able to choose the face that best illustrates the physical pain they are experiencing. It is a tool to be used by a third person, parents, healthcare professionals, or caregivers, to assess the patient's pain. The scale is 0-10 scale. The six illustrated faces on the cards show a range of emotions, from a smiling face (0 'no pain) to a crying face (10 "worst pain"). 0 indicates no pain, 10 indicates the most severe pain. It defines the child's pain level before and after the blood collection.

Study Sites (1)

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