- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04421430
Nonpharmacological Methods for Children in Procedural Pain
June 4, 2020 updated by: Aynur Aytekin Ozdemir, Istanbul Medeniyet University
The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy® (Randomized Controlled Trial)
The aim of this study was to determine the effect of the distraction cards, virtual reality and Buzzy® methods on venipuncture pain and anxiety in children aged 7-12 years.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) recommends pharmacological and nonpharmacological methods to effectively manage and prevent acute procedural pain in children.
Nonpharmacological methods alone or in combination with pharmacological methods help reduce pain, and therefore, have become popular especially in recent years.
For pain management, nonpharmacological methods are easy to use, and cost- and time-effective methods with no side effects.
Studies have evaluated a large number of pharmacological and nonpharmacological interventions for procedural pain management in children.
However, most of those interventions are not used by healthcare professionals because they are expensive, time-consuming or hard to use.
Therefore, easy-to-use, practical, non-invasive, cost-effective, and reusable nonpharmacological methods, such as distraction cards, virtual reality and Buzzy®, can be used especially in acute settings.
Study Type
Interventional
Enrollment (Actual)
160
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
-
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Kadıköy
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Istanbul, Kadıköy, Turkey, 34720
- Istanbul Medeniyet University
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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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Due to undergo venipuncture for blood testing
- Suitable for venipuncture at antecubital location using a 21 Gauge X 1.5 inch needle
- Due to undergo venipuncture under the same environmental conditions (phlebotomy seat, heat, light, noise, etc.)
- Due to undergo venipuncture at the first attempt
Exclusion Criteria:
Children;
- had chronic diseases
- had neuro-developmentally delayed
- had visual, audio, or speech impairments
- were hospital stay for treatment
- had a history of sedative, analgesic or narcotic use within 24 hours before admission
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Distraction cards group
Distraction cards was applied to the children in this group during the venipuncture procedure.
|
The distraction cards contain various hidden pictures and patterns which are visible only when looked at carefully.
During a procedure, the child is expected to focus on the cards and answer the questions asked about what they see in them.
Just before the venipuncture, the researcher showed the distraction cards participants the distraction cards and asked them to check them and then asked them questions about what they saw on the cards and kept asking questions until the end of the venipuncture.
The distraction cards intervention and venipuncture were terminated at the same time.
Other Names:
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Experimental: Virtual reality group
Virtual reality intervention was applied to the children in this group during the venipuncture procedure.
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The virtual reality participants put on the virtual reality glasses and headsets about two minutes before the venipuncture and watched the 3D Dinosaur Animation movie throughout the procedure.
The virtual reality intervention and venipuncture were terminated at the same time.
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Experimental: Buzzy® group
Buzzy® was applied to the children in this group during the venipuncture procedure.
|
Buzzy® applies high frequency vibration and concentrated cold at injection site for procedural pain management and distraction before the shot in children and adults.
Buzzy® was placed on the injection site (antecubital fossa) of the Buzzy® participants, and cold application and vibration was turned on 60 seconds before the procedure.
After the 60 seconds, the nurse moved Buzzy® about 3 cm above the injection site and applied a tourniquet and performed the procedure.
Buzzy® was on throughout the procedure.
The Buzzy® intervention and venipuncture were terminated at the same time.
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No Intervention: Control group
The control group received the routine venipuncture procedure and did not receive any other non-pharmacological intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale (VAS)
Time Frame: Through painful procedure completion, an average of 10 minutes
|
The VAS is used to measure and monitor pain intensity.
VAS is a 10 cm or 100 mm long horizontal or vertical line with anchor statements "no pain or pain at its least" at the left-most end and "unbearable pain or worst pain imaginable" at the right-most end.
The participant is asked to mark a point on the line that best represents their pain level.
The VAS score is determined by measuring (in cm) the distance of the mark from the left end of the line.
VAS is an easy-to-understand and easy-to-measure scale for children aged 7 and over.
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Through painful procedure completion, an average of 10 minutes
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Wong-Baker FACES Pain Rating Scale (WB-FACES)
Time Frame: Through painful procedure completion, an average of 10 minutes
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The WB-FACES was developed by Wong and Baker in 1981 and revised in 1983.
The scale is used to diagnose pain in children aged 3-18 years.
It consists of six facial expressions, each one representing an increasing degree of pain scored on a scale 0 to 5 from left to right (0 = very happy/no pain, 5 = the worst pain imaginable).
The first face is a happy face representing "no pain" (0) while the last face is a crying face representing "the worst pain imaginable" (5).
Higher scores indicate low pain tolerance.
Participants are asked to choose the facial expression that best represents their pain.
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Through painful procedure completion, an average of 10 minutes
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Children's Fear Scale (CFS)
Time Frame: Through painful procedure completion, an average of 10 minutes
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The CFS was developed by McMurtry et al. (2011) to measure fear and anxiety in children.
It consists of five facial expressions that represent a range from neutral (0) to extreme fear (4).
Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedures
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Through painful procedure completion, an average of 10 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aynur Aytekin Özdemir, PhD, Istanbul Medeniyet University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
- Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
- Ball, J. W., Bindler, R. C., &Cowen, K. J. (2010). Child Health Nursing: Partnering withak Children and Families. (2 th ed.) London: Pearson Education (Chapter 2).
- Twycross A. (2009). Managing pain in children. In: Dowden, S. J., & Bruce, E., (eds.). A Clinical Guide (pp. 42-49). New Jersey: Blackwell Publishing Ltd.
- Erdogan B, Aytekin Ozdemir A. The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy(R) (Randomized Controlled Trial). J Pediatr Nurs. 2021 May-Jun;58:e54-e62. doi: 10.1016/j.pedn.2021.01.001. Epub 2021 Jan 21.
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)
November 16, 2017
Primary Completion (Actual)
May 31, 2018
Study Completion (Actual)
August 14, 2018
Study Registration Dates
First Submitted
June 3, 2020
First Submitted That Met QC Criteria
June 4, 2020
First Posted (Actual)
June 9, 2020
Study Record Updates
Last Update Posted (Actual)
June 9, 2020
Last Update Submitted That Met QC Criteria
June 4, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-10/9
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
It will be shared after the article is published.
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.
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