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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05064657
Other study ID # SelcukU-01-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 20, 2020
Est. completion date October 31, 2020

Study information

Verified date October 2021
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 111
Est. completion date October 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Selcuk University Konya Selcuklu

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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