The Effect of Virtual Reality and Kaleidoscope on Pain and Anxiety Levels During Venipuncture in Children
Adiyaman University
1 other identifier
interventional
135
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2018
CompletedFirst Submitted
Initial submission to the registry
April 10, 2019
CompletedFirst Posted
Study publicly available on registry
April 12, 2019
CompletedApril 16, 2019
April 1, 2019
5 months
April 10, 2019
April 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 minute
Secondary Outcomes (2)
Visual Analogue Scale
1 minute
Wong Baker Face Pain Scale
1 minute
Study Arms (3)
virtual reality group
EXPERIMENTALThe children in the groups were distracted by virtual reality goggles 2 minutes before venipuncture, until the process was over.
kaleidoscope group
EXPERIMENTALThe children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over.
control group
NO INTERVENTIONNo intervention was made to children in the control group
Interventions
The children in the groups were distracted by virtual reality goggles and kaleidoscope 2 minutes before venipuncture, until the process was over
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- having a chronic, mental or neurological illness,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Adiyaman University
Adıyaman, 02100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 10, 2019
First Posted
April 12, 2019
Study Start
June 26, 2018
Primary Completion
November 27, 2018
Study Completion
November 27, 2018
Last Updated
April 16, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share