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

Adiyaman University

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Other: distraction methods

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Adiyaman, Turkey, 02100
    • Adiyaman University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	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.	1 minute
Wong Baker Face Pain Scale	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').	1 minute

Collaborators and Investigators

• Sponsor: Adiyaman University Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 26, 2018
• Primary Completion (ACTUAL): November 27, 2018
• Study Completion (ACTUAL): November 27, 2018

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (ACTUAL): April 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: children; acute pain; nursing; distraction; blood collection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 2018/5-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No