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

NCT05064657 | Completed

• 1 other identifier: SelcukU-01-2020
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Procedural; Pain Management; Child, Only

Keywords

pain; procedural; fear; child; distraction methods

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Experimental Group

EXPERIMENTAL

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

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

Control Group

NO INTERVENTION

No intervention

Interventions

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.

Also known as: Ball squeezing method

Active Comparator; Experimental Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42060, Turkey (Türkiye)

Location

Related Publications (1)

• Oluc N, Tas Arslan F. The effect of two different methods on reducing the pain and fear during phlebotomy to children: A randomized controlled trial. Int Emerg Nurs. 2024 Feb;72:101386. doi: 10.1016/j.ienj.2023.101386. Epub 2023 Nov 18.

  PMID: 37984025 DERIVED

MeSH Terms

Conditions

Pain, Procedural; Agnosia; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Fatma Tas Arslan, Prof.

  Selcuk University

  STUDY DIRECTOR

• Neşe Oluç, Msc

  Selcuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: October 1, 2021
• Study Start: July 20, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

TU (1)