Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection

October 12, 2019 updated by: Tuba Koc Ozkan, Adiyaman University Research Hospital

Aim:This study was conducted to investigate the effects of music, kaleidoscope and video watching methods on children's pain perception and anxiety level during the blood collection procedures.

Methods: This randomized controlled experimental study was carried out with 134 children in the 5-10 age group in the pediatric blood collection unit of a Training and Research Hospital between August and November 2018. In the study, nonpharmacological methods were applied to the children in the experimental groups (Music Group (n=33), Kaleidoscope Group (n=36), Video Group (n=31). The routine blood collection procedure was used for the children in the control group (n=34). The data were collected using the "Introductory Information Form", "Children's Fear and Anxiety Scale (CFAS)", and the "Wong-Baker Faces Pain Rating Scale (WB-FPRS)".

Study Overview

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Adiyaman, Turkey, 02100
        • Adiyaman University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • being healthy
  • ability to express himself/herself verbally
  • no analgesic taken in the last 6 hours
  • having no visual or auditory problems

Exclusion Criteria:

  • chronic disease
  • mental disease
  • neurological disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: music group
The children in the groups were distracted by listening music 2 minutes before venipuncture, until the process was over.
The children in the groups were distracted by music 2 minutes before venipuncture, until the process was over
Experimental: kaleidescope group
The children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over.
The children in the groups were distracted by kaleidoscope 2 minutes before venipuncture, until the process was over
Experimental: video group
The children in the groups were distracted by watching cartoon 2 minutes before the blood collection, until the process was over.
The children in the groups were distracted by watching video 2 minutes before venipuncture, until the process was over
No Intervention: control group
No intervention was made to children in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children Fear Scale
Time Frame: 1 minute
The Children Fear Scale was used to evaluate the children's fear and anxiety. Children Fear Scale is a 0-4 scale, showing five faces that range from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). Preprocedural and procedural pain, and anxiety were evaluated
1 minute
Wong Baker Face Pain Scale
Time Frame: 1 minute
The Wong Baker Faces scale is a 0-10 scale. Six faces on the cards show a range of emotions from a smiling face (0 very happy/no pain) to a crying face (10 'hurts worst').
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

October 1, 2019

First Posted (Actual)

October 3, 2019

Study Record Updates

Last Update Posted (Actual)

October 15, 2019

Last Update Submitted That Met QC Criteria

October 12, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adiyaman University/2018/2-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Pain

Clinical Trials on music group

Subscribe