Back to resultsThe Effect of Virtual Reality and Kaleidoscope on Pain and Anxiety Levels During Venipuncture in Children
Primary Purpose
Acute Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
distraction methods
Sponsored by
About this trial
This is an interventional prevention trial for Acute Pain focused on measuring acute pain, blood collection, nursing, children, distraction
Eligibility Criteria
Inclusion Criteria:
- being aged between 4 and 10 years for the child,
- applying for health control purpose,
- not having any chronic, mental or neurological illness,
- not using any analgesic in the last 6 hours before the venipuncture procedure.
Exclusion Criteria:
-having a chronic, mental or neurological illness,
Sites / Locations
- Adiyaman University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
virtual reality group
kaleidoscope group
control group
Arm Description
The children in the groups were distracted by virtual reality goggles 2 minutes before venipuncture, until the process was over.
The children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over.
No intervention was made to children in the control group
Outcomes
Primary Outcome Measures
Children Fear Scale
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
Secondary Outcome Measures
Visual Analogue Scale
The visual analogue scale has been used for evaluating pain levels. Children were asked to mark the level of their pain on a l00 mm., Visual Analogue scale marked at one end as "no pain" and at the other as "worst pain imaginable.
Wong Baker Face Pain Scale
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').
Full Information
NCT ID
NCT03913897
First Posted
April 10, 2019
Last Updated
April 11, 2019
Sponsor
Adiyaman University Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03913897
Brief Title
The Effect of Virtual Reality and Kaleidoscope on Pain and Anxiety Levels During Venipuncture in Children
Official Title
Adiyaman University
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
November 27, 2018 (Actual)
Study Completion Date
November 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adiyaman University Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Aim: The study was carried out in randomized control to determine the effect of two different distractions on pain and anxiety during blood collection.
Methods: The population of the study consisted of children between ages of 4-10 years who applied for venipuncture to a training and research hospital in Turkey between July and December 2018. A total of 139 children were included in the study, 46 of them with virtual reality goggles and 43 of them with control group. Information Form, Child Anxiety Scale, Visual Analogue Scale and Wong Baker Pain Scale were used in the collection of data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
acute pain, blood collection, nursing, children, distraction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
virtual reality group
Arm Type
Experimental
Arm Description
The children in the groups were distracted by virtual reality goggles 2 minutes before venipuncture, until the process was over.
Arm Title
kaleidoscope group
Arm Type
Experimental
Arm Description
The children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over.
Arm Title
control group
Arm Type
No Intervention
Arm Description
No intervention was made to children in the control group
Intervention Type
Other
Intervention Name(s)
distraction methods
Intervention Description
The children in the groups were distracted by virtual reality goggles and kaleidoscope 2 minutes before venipuncture, until the process was over
Primary Outcome Measure Information:
Title
Children Fear Scale
Description
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
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
The visual analogue scale has been used for evaluating pain levels. Children were asked to mark the level of their pain on a l00 mm., Visual Analogue scale marked at one end as "no pain" and at the other as "worst pain imaginable.
Time Frame
1 minute
Title
Wong Baker Face Pain Scale
Description
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').
Time Frame
1 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
being aged between 4 and 10 years for the child,
applying for health control purpose,
not having any chronic, mental or neurological illness,
not using any analgesic in the last 6 hours before the venipuncture procedure.
Exclusion Criteria:
-having a chronic, mental or neurological illness,
Facility Information:
Facility Name
Adiyaman University
City
Adiyaman
ZIP/Postal Code
02100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Virtual Reality and Kaleidoscope on Pain and Anxiety Levels During Venipuncture in Children
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