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

Not Applicable

Completed

• Conditions: Acute Pain
• Interventions: Other: distraction methods

• Registration Number: NCT03913897
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-26
• Primary Completion: 2018-11-27
• Study Completion: 2018-11-27
• Status Verified: 2019-04
• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-11
• Last Update Submitted: 2019-04-11
• Study First Posted: 2019-04-12
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
virtual reality group	distraction methods	The children in the groups were distracted by virtual reality goggles 2 minutes before venipuncture, until the process was over.
kaleidoscope group	distraction methods	The children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over.

Primary Outcome Measures

Name	Time	Method
Children Fear Scale	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

Name	Time	Method
Wong Baker Face Pain Scale	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').
Visual Analogue Scale	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.

Trial Locations

Locations (1)

Adiyaman University; 🇹🇷 Adiyaman, Turkey