NCT03913897

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

April 10, 2019

Last Update Submit

April 11, 2019

Conditions

Keywords

acute painblood collectionnursingchildrendistraction

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

EXPERIMENTAL

The children in the groups were distracted by virtual reality goggles 2 minutes before venipuncture, until the process was over.

Other: distraction methods

kaleidoscope group

EXPERIMENTAL

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

Other: distraction methods

control group

NO INTERVENTION

No 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

kaleidoscope groupvirtual reality group

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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)

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations