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

• ClinicalTrials.gov Identifier: NCT03913897
• Recruitment Status: Completed
• First Posted: April 12, 2019
• Last Update Posted: April 16, 2019
• Sponsor: Adiyaman University Research Hospital
• Information provided by (Responsible Party): Tuba Koc Ozkan, Adiyaman University Research Hospital

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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').

Eligibility Criteria

• 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,

Contacts and Locations

Locations

Turkey

Adiyaman University

Adiyaman, Turkey, 02100

Sponsors and Collaborators

Adiyaman University Research Hospital

More Information

• Responsible Party: Tuba Koc Ozkan, Principal Investigator, Adiyaman University Research Hospital
• ClinicalTrials.gov Identifier: NCT03913897
• Other Study ID Numbers: 2018/5-18
• First Posted: April 12, 2019
• Last Update Posted: April 16, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Acute Pain; Pain; Neurologic Manifestations