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Completed

NCT Number: NCT05064657

The Effect of Two Method to 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.

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Key information

Conditions

Pain, Procedural Agnosia Child, Only Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, Selcuklu, 42060, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bubble blowing method

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 1, 2021
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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