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Clinical Trials/NCT03913897
NCT03913897
Completed
Not Applicable

Adiyaman University

Adiyaman University Research Hospital1 site in 1 country135 target enrollmentJune 26, 2018
ConditionsAcute Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Pain
Sponsor
Adiyaman University Research Hospital
Enrollment
135
Locations
1
Primary Endpoint
Children Fear Scale
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 26, 2018
End Date
November 27, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Adiyaman University Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tuba Koc Ozkan

Principal Investigator

Adiyaman University Research Hospital

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,

Outcomes

Primary Outcomes

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 Outcomes

  • Wong Baker Face Pain Scale(1 minute)
  • Visual Analogue Scale(1 minute)

Study Sites (1)

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