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FearNCT05564260

The Effects of Virtual Reality and Kaleidoscope

A study testing Kaleidescope and Virtual Reality in people with Fear and Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 7 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Fear, Pain
What is being tested?
Kaleidescope and Virtual Reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2020to 1 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bafra State Hospital

    Samsun

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Virtual Reality and Kaleidoscope on Pain and Fear During Blood Draw in Children: A Randomized Controlled Trial

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.

Read the 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.

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. 14-16 Wong-Baker FACES Pain Rating Scale (FACES): This scale is used for children aged 3 years and older in order to rate severity of pain. In this numerical rating scale, scores given by the child range between 0 and 10. Faces show emotions from smiling (0= very happy/no pain) to crying (10= the most painful).17 In this study, children were assessed by the researcher and nurse in the clinic during post-procedure. Wong-Baker Faces Pain Rating Scale (FACES) is a commonly used scale to evaluate pain in pediatric group in Turkish population. 11,18 The Children's Fear Scale (CFS): 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.19,20 The directions of Children's Fear Scale was changed in line with the fear-related word capacity of the children developmentally.19 Psychometric properties of the scale in Turkish population were carried out by Gerceker, Ayar, Ozdemir et al. 20 Fear scale was assessed before and after the blood draw procedure by the child, parent and researcher during the study.

'VR BOX 3D' virtual reality glasses compatible with smartphones were used in the study. While using VR, there is no need for any power or connection unit other than the phone. All children in the study were made to watch the same video (Puss in Boots The Three Musketeers/Looney Tunes Road Runner) recommended by the experts based on children ages. Five children between 7-12 years old were made to watch selected videos before starting the study. There was no negative feedback

Conditions
Fear, Pain
Being tested
Kaleidescope, Virtual Reality
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KaleidescopeBehavioural

    Also called distraction methods

    watching kaleidescope

  • Virtual RealityBehavioural

    Also called distraction methods

    wearing virtual reality glasses

Study groups in NCT05564260
Study groupRoleWhat they receive
The Kaleidescope GroupExperimentalKaleidoscope was watched during blood drawing
Receives: Behavioral: Kaleidescope
The VR GroupExperimentalwatching the application by wearing virtual glasses to the child during the blood drawing
Receives: Behavioral: Virtual Reality
Control GroupNo interventionNo intervention was made.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain assesed by child, parent, nurse with Wong-Baker FACES

    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).

    Measured: during procedure

  2. Pain assesed by Visual Analohg Scale (VAS)

    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

    Measured: during procedure

  3. Fear assesed by The Children's Fear Scale (CFS)

    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

    Measured: during procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2022
  2. Study start1 Jan 2020
  3. Primary completion1 Jul 2020
  4. Study completion1 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05564260
Sponsor's protocol ID
0.20.08/687-905- 10.10.2019
Status last verified
Sep 2022
First submitted
28 Sep 2022
Last updated
3 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Kaleidescope and Virtual Reality in people with Fear and Pain, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain assesed by child, parent, nurse with Wong-Baker FACES (time frame: during procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.

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