The Effects of Virtual Reality and Kaleidoscope on Pain and Fear During Blood Draw in Children: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- Pain assesed by child, parent, nurse with Wong-Baker FACES
Study Overview
Brief Summary
In literature review, many studies have been found to support the positive effects of various nonpharmacological methods in the alleviation of pain and fear created by invasive procedures.This study was carried out to determine the effects of kaleidoscope and cartoon watching using the virtual reality glasses on the pain and fear states of children during blood draw procedure.
Detailed Description
This study was carried out to determine the effects of kaleidoscope and cartoon watching using the virtual reality glasses on the pain and fear states of children during blood draw procedure.
H0: There are no significant differences in the mean pain and fear scores of the children who used kaleidoscope and cartoon watching using virtual reality glasses methods.
H1: Mean pain and fear score of the children who used kaleidoscope during blood draw procedure is lower than the ones who did not.
H2: Mean pain and fear score of the children who used virtual reality glasses during blood draw procedure is lower than the ones who did not.
This study was carried out with 7-12 year old children who were admitted to blood draw unit of a hospital in Turkey between January 21-April 21, 2020. Sample size was calculated as 156 including 52 individuals per each group in the study (52 in the kaleidoscope group, 52 in the virtual reality group and 52 in the control group). However, 2 children were lost in all groups due to the inability to draw blood with one entry and data were completed with a total of 150 children. Groups were generated by using randomization method. Participant Information Form: This form included sociodemographic characteristics (age, sex, presence of chronic disease) of the children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 7 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •being literate for the child and parent
- •being 7-12 years old
- •having no vision or hearing problems
- •having no chronic or mental health problem.
Exclusion Criteria
- •the child with physical and psychological deficit to prevent him from wearing the glasses to be worn on his head so that he can watch virtual reality.
- •having vision or hearing problems
- •having chronic or mental health problem.
Arms & Interventions
The Kaleidescope Group
Kaleidoscope was watched during blood drawing
Intervention: Kaleidescope (Behavioral)
The VR Group
watching the application by wearing virtual glasses to the child during the blood drawing
Intervention: Virtual Reality (Behavioral)
Control Group
No intervention was made.
Outcomes
Primary Outcomes
Pain assesed by child, parent, nurse with Wong-Baker FACES
Time Frame: during procedure
Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst). Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).
Pain assesed by Visual Analohg Scale (VAS)
Time Frame: during procedure
Visual Analog Scale (VAS): Visual Analog Scale, which is used to measure severity of pain consists of a horizontal or vertical ruler at a length of 10 cm or 100 mm which has "no pain" on one side and "the most severe pain possible" on the other side. While there is "no pain" expression on the left side of the ruler, there is "unberable pain" expression on the right side. VAS is described as understandable and easy-to-use for the children over 7 years old. Its validity and reliability have been shown in the previous studies
Fear assesed by The Children's Fear Scale (CFS)
Time Frame: during procedure
This is a one-item self-report scale which is used to measure pain-associated fear. This one-item scale is composed of five neutral faces in terms of sex. There is a face showing no fear on the left and a face showing extreme fear on the right. The response of the evaluator shows the level of fear. It can be used by the parents and researchers before and during the procedure for the children aged 5-10 years old
Secondary Outcomes
No secondary outcomes reported
Investigators
Esra TURAL BUYUK
Principal Investigator
Ondokuz Mayıs University