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Nonpharmacological Methods for Children in Procedural Pain

Primary Purpose

Procedural Pain, Procedural Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Distraction cards
Virtual reality
Buzzy
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Procedural Pain focused on measuring Anxiety, Children, Nursing, Acute pain management

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Istanbul Medeniyet University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Distraction cards group

Virtual reality group

Buzzy® group

Control group

Arm Description

Distraction cards was applied to the children in this group during the venipuncture procedure.

Virtual reality intervention was applied to the children in this group during the venipuncture procedure.

Buzzy® was applied to the children in this group during the venipuncture procedure.

The control group received the routine venipuncture procedure and did not receive any other non-pharmacological intervention.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)
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.
Wong-Baker FACES Pain Rating Scale (WB-FACES)
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.
Children's Fear Scale (CFS)
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

Secondary Outcome Measures

Full Information

First Posted
June 3, 2020
Last Updated
June 4, 2020
Sponsor
Istanbul Medeniyet University
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1. Study Identification

Unique Protocol Identification Number
NCT04421430
Brief Title
Nonpharmacological Methods for Children in Procedural Pain
Official Title
The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy® (Randomized Controlled Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 16, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
August 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Pain, Procedural Anxiety
Keywords
Anxiety, Children, Nursing, Acute pain management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomized into the experimental and control groups using a block randomization method. Literature shows that age, gender, and fear are three factors affecting procedural pain and anxiety in children (Ball, Bindler, & Cowen, 2010; Twycross, 2009). Therefore, the variables of age (7-9 and 10-12 years), gender (girls and boys), and fear of procedure (yes and no) were used for block randomization. The blocks were repeated five times in each group (2X2X2X5), and 40 participants were assigned to each. The sealed envelope method was used to randomly assign participants to the groups.
Masking
Investigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Distraction cards group
Arm Type
Experimental
Arm Description
Distraction cards was applied to the children in this group during the venipuncture procedure.
Arm Title
Virtual reality group
Arm Type
Experimental
Arm Description
Virtual reality intervention was applied to the children in this group during the venipuncture procedure.
Arm Title
Buzzy® group
Arm Type
Experimental
Arm Description
Buzzy® was applied to the children in this group during the venipuncture procedure.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group received the routine venipuncture procedure and did not receive any other non-pharmacological intervention.
Intervention Type
Other
Intervention Name(s)
Distraction cards
Other Intervention Name(s)
Flippits1, MMJ Labs, Atlanta, Georgia, ABD
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Buzzy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
Through painful procedure completion, an average of 10 minutes
Title
Wong-Baker FACES Pain Rating Scale (WB-FACES)
Description
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.
Time Frame
Through painful procedure completion, an average of 10 minutes
Title
Children's Fear Scale (CFS)
Description
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
Time Frame
Through painful procedure completion, an average of 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aynur Aytekin Ozdemir, PhD
Organizational Affiliation
Istanbul Medeniyet University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medeniyet University
City
Istanbul
State/Province
Kadıköy
ZIP/Postal Code
34720
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be shared after the article is published.
Citations:
Citation
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).
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
3344163
Citation
Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
Results Reference
background
PubMed Identifier
21806301
Citation
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.
Results Reference
background
PubMed Identifier
33485746
Citation
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.
Results Reference
derived

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Nonpharmacological Methods for Children in Procedural Pain

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