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

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ClinicalTrials.gov Identifier: NCT03913897
Recruitment Status : Completed
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Tuba Koc Ozkan, Adiyaman University Research Hospital

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.


Condition or disease Intervention/treatment Phase
Acute Pain Other: distraction methods Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adiyaman University
Actual Study Start Date : June 26, 2018
Actual Primary Completion Date : November 27, 2018
Actual Study Completion Date : November 27, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: virtual reality group
The children in the groups were distracted by virtual reality goggles 2 minutes before venipuncture, until the process was over.
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

Experimental: kaleidoscope group
The children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over.
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

No Intervention: control group
No intervention was made to children in the control group



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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').



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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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,


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913897


Locations
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Turkey
Adiyaman University
Adiyaman, Turkey, 02100
Sponsors and Collaborators
Adiyaman University Research Hospital

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Responsible Party: Tuba Koc Ozkan, Principal Investigator, Adiyaman University Research Hospital
ClinicalTrials.gov Identifier: NCT03913897     History of Changes
Other Study ID Numbers: 2018/5-18
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tuba Koc Ozkan, Adiyaman University Research Hospital:
acute pain
blood collection
nursing
children
distraction
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms