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

Primary Purpose

Pain, Procedural, Pain Management, Child, Only

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bubble blowing method
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Procedural focused on measuring pain, procedural, fear, child, distraction methods

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Selcuk University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Experimental Group

Active Comparator

Control Group

Arm Description

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.

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.

No intervention

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 29, 2021
Last Updated
October 20, 2021
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT05064657
Brief Title
The Effect of Two Method to Reducing Pain and Fear During Draw Blood From Children
Official Title
The Effect of Two Different Applications on Reducing Pain and Fear During Draw Blood From Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural, Pain Management, Child, Only
Keywords
pain, procedural, fear, child, distraction methods

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment First sub purpose was designed as parallel group, two intervention groups in pre-test and post-test order, and a randomized controlled control group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Procedure
Intervention Name(s)
Bubble blowing method
Other Intervention Name(s)
Ball squeezing method
Intervention Description
The investigators were used "Bubble blowing method" and "ball squeezing method". To child were used a ball squeezing method during the blood collection process.
Primary Outcome Measure Information:
Title
Wong Baker Pain Faces Scale mean score
Description
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.
Time Frame
First ten minute
Title
Children's Fear Scale mean score
Description
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.
Time Frame
First ten minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Tas Arslan, Prof.
Organizational Affiliation
Selcuk University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Neşe Oluç, Msc
Organizational Affiliation
Selcuk University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University
City
Konya
State/Province
Selcuklu
ZIP/Postal Code
42060
Country
Turkey

12. IPD Sharing Statement

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

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