The Effect of Two Method to Reducing Pain and Fear During Draw Blood From Children

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; Pain, Procedural; Child, Only
• Intervention / Treatment: Procedure: Bubble blowing method

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

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Selcuklu
    • Konya, Selcuklu, Turkey, 42060
      • Selcuk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; No intervention
Experimental: Experimental Group; Experimental Group (ball squeezing) The group were used a ball squeezing method during the blood collection process. The children were given a ball during the blood draw and told to tighten and loosen it.	Procedure: Bubble blowing method; The investigators were used "Bubble blowing method" and "ball squeezing method". To child were used a ball squeezing method during the blood collection process.; Other Names: Ball squeezing method
Active Comparator: Active Comparator; Active Comparator ( bubble blowing) The group were used a bubble blowing method during the blood collection process. During the blood collection process, the children were asked to blow bubbles by giving the apparatus inside the foam bubble to their free arm.	Procedure: Bubble blowing method; The investigators were used "Bubble blowing method" and "ball squeezing method". To child were used a ball squeezing method during the blood collection process.; Other Names: Ball squeezing method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wong Baker Pain Faces Scale mean score	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.	First ten minute
Children's Fear Scale mean score	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.	First ten minute

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Study Director: Fatma Tas Arslan, Prof., Selcuk University; Principal Investigator: Neşe Oluç, Msc, Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: pain; child; fear; distraction methods; procedural
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural
• Other Study ID Numbers: SelcukU-01-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No