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).
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
- What is being tested?
- Kaleidescope and Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
- 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 group | Role | What they receive |
|---|---|---|
| The Kaleidescope Group | Experimental | Kaleidoscope was watched during blood drawing Receives: Behavioral: Kaleidescope |
| The VR Group | Experimental | watching the application by wearing virtual glasses to the child during the blood drawing Receives: Behavioral: Virtual Reality |
| Control Group | No intervention | No intervention was made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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.
- First posted3 Oct 2022
- Study start1 Jan 2020
- Primary completion1 Jul 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FearStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra TURAL BUYUK, Ondokuz Mayıs University
- Investigators
- Esra Tural Buyuk, Principal investigator, Phd, RN
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Reality and Kaleidoscope on Pain and Fear During Blood Draw in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05564260
- Acronym / sponsor ID
- 0.20.08/687-905- 10.10.2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Kaleidescope Group | Experimental | Behavioral: KaleidescopeKaleidoscope was watched during blood drawing |
| The VR Group | Experimental | Behavioral: Virtual Realitywatching the application by wearing virtual glasses to the child during the blood drawing |
| Control Group | No intervention | –No intervention was made. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KaleidescopeAlso: distraction methodswatching kaleidescope | Behavioural | The Kaleidescope Group |
| Virtual RealityAlso: distraction methodswearing virtual reality glasses | Behavioural | The VR Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esra Tural Buyuk principal investigator
Phd, RN
1 site in 1 country: see every site and its status.
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.