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The Effect of Virtual Reality and Kaleidoscope on Pain and Anxiety Levels During Venipuncture in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03913897
Recruitment Status : Completed
First Posted : April 12, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Tuba Koc Ozkan, Adiyaman University Research Hospital

Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE April 12, 2019
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE June 26, 2018
Actual Primary Completion Date November 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Visual Analogue Scale [ Time Frame: 1 minute ]
    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 [ 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').
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Virtual Reality and Kaleidoscope on Pain and Anxiety Levels During Venipuncture in Children
Official Title  ICMJE Adiyaman University
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Acute Pain
Intervention  ICMJE Other: distraction methods
The children in the groups were distracted by virtual reality goggles and kaleidoscope 2 minutes before venipuncture, until the process was over
Study Arms  ICMJE
  • Experimental: virtual reality group
    The children in the groups were distracted by virtual reality goggles 2 minutes before venipuncture, until the process was over.
    Intervention: Other: distraction methods
  • Experimental: kaleidoscope group
    The children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over.
    Intervention: Other: distraction methods
  • No Intervention: control group
    No intervention was made to children in the control group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2019)
135
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 27, 2018
Actual Primary Completion Date November 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03913897
Other Study ID Numbers  ICMJE 2018/5-18
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tuba Koc Ozkan, Adiyaman University Research Hospital
Study Sponsor  ICMJE Adiyaman University Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Adiyaman University Research Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP