Acute PainNCT06192498
Effects of Virtual Reality Glasses, Kaleidoscope and Distraction Cards on Pain and Anxiety During Blood Draw in Children
A study testing Virtual Reality Glasses, Kaleidoscope and Distraction Cards in people with Acute Pain and Virtual Reality, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using Virtual Reality Glasses, Kaleidoscope and Distraction Cards in reducing pain and anxiety during blood draw in children. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Virtual Reality, Kaleidoscope
- What is being tested?
- Virtual Reality Glasses, Kaleidoscope and Distraction Cards
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 30 Dec 2019
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of 7-11,
- Volunteering of the child and parent to participate in the study,
- Blood draw for routine control purposes,
- Blood draw should be done by the same nurse,
- The needle on which blood draw will be performed must be of the same thickness.
Who cannot join
- The child has any acute or chronic disease,
- The child has a mental disability, vision, speech or communication problems,
- The parent has hearing, vision or verbal communication difficulties,
- The child used analgesics in the last 6 hours,
- Infection, disruption of skin integrity and rash in the area where the application will be made,
- Exclusion criteria were that the parent or child wanted to leave the study at any point.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Education and Research Hospital
Karaman
About this study
Official title: Comparison of the Effectiveness of Virtual Reality Glasses, Kaleidoscope and Distraction Cards in Reducing Pain and Anxiety During Blood Draw in Children: A Randomized Controlled Study
The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using Virtual Reality Glasses, Kaleidoscope and Distraction Cards in reducing pain and anxiety during blood draw in children.
Read the detailed description
n the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. In light of this information, this study aimed to compare the effect of distraction by using Virtual Reality Glasses, Kaleidoscope and Distraction Cards in reducing pain and anxiety during blood draw in children.
This study is a prospective, randomized and controlled trial. Children aged 7 to 11 years who required blood draw were divided into three groups; Virtual Reality Glasses, Kaleidoscope, Distraction Cards and Control. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's pain levels were assessed and reported by the parents and observers and the children themselves who self-reported using Wong-Baker FACES. The children's anxiety levels were also assessed using the Children's Fear Scale.
The study population consisted of children aged 7 to 11 years who presented to the children's blood draw room of the hospital.
Sample of the study consisted of a total of 400 children who met the sample selection criteria and were selected via randomization method.
Children were randomized into three groups: Virtual Reality Glasses group (n= 100), Kaleidoscope group (n= 100), Distraction Cards group (n= 100) and Control group (n= 100).
Data were collected using the Interview and Observation Form, Wong-Baker FACES Pain Rating Scale, Children's Fear Scale.
- Conditions
- Acute Pain, Virtual Reality, Kaleidoscope, Distraction Cards, Nursing Caries, Children, Only
- Being tested
- Virtual Reality Glasses, Kaleidoscope, Distraction Cards
- Medical subject headings
- Acute Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GlassesOther
Virtual Reality(VR) Glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses before starting the application and it continued until the end of the Blood Draw procedure.
KaleidoscopeOther
Kaleidoscope were introduced to the children pre-procedure. The children were made to watch Kaleidoscope before starting the application and it continued until the end of the Blood Draw procedure.
Distraction CardsOther
Distraction Cards were introduced to the children pre-procedure. The children were made to apply Distraction Cards before starting the application and it continued until the end of the Blood Draw procedure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Glasses Group | Experimental | Virtual Reality(VR) Glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses before starting the application and it continued until the end of the Blood Draw procedure. Receives: Other: Virtual Reality Glasses |
| Kaleidoscope Group | Experimental | Kaleidoscope were introduced to the children pre-procedure. The children were made to watch Kaleidoscope before starting the application and it continued until the end of the Blood Draw procedure. Receives: Other: Kaleidoscope |
| Distraction Cards Group | Experimental | Distraction Cards were introduced to the children pre-procedure. The children were made to apply Distraction Cards before starting the application and it continued until the end of the Blood Draw procedure. Receives: Other: Distraction Cards |
| Control Group | No intervention | In this group, children received routine blood draw procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker FACES Pain Rating Scale
In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.
Measured: Through painful procedure completion, an average of 10 minutes
Children's Fear Scale
CFS is used for measuring the child's anxiety level. CFS is a scale which makes an evaluation from 0 to 4 consisting of five facial expressions drawn to show expressions that vary from neutral expression (0=no anxiety) to scared face (4=severe anxiety).
Measured: Through painful procedure completion, an average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Aug 2018
- Primary completion7 Oct 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Ateş Beşirik, Burdur Mehmet Akif Ersoy University
- Investigators
- Selda Ateş Beşirik, PhD., Principal investigator, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192498
- Sponsor's protocol ID
- 07-2018/22
- Status last verified
- Jan 2024
- First submitted
- 21 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ates Besirik S, Canbulat Sahiner N. Comparison of the effectiveness of three different distraction methods in reducing pain and anxiety during blood drawing in children: A randomized controlled study. J Pediatr Nurs. 2024 Nov-Dec;79:225-233. doi: 10.1016/j.pedn.2024.09.009. Epub 2024 Sep 19.
PubMed 39303378
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Virtual Reality Glasses, Kaleidoscope and Distraction Cards in Reducing Pain and Anxiety During Blood Draw in Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06192498
- Acronym / sponsor ID
- 07-2018/22
- Conditions
- Acute Pain, Virtual Reality, Kaleidoscope, Distraction Cards, Nursing Caries, Children, Only
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 5 Jan 2024 (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.
The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using Virtual Reality Glasses, Kaleidoscope and Distraction Cards in reducing pain and anxiety during blood draw in children.
Detailed description
n the literature, it is stated that nurses should use pharmacological and non-pharmacological methods in pain and anxiety management in painful procedures. Evidence-based studies are needed to show the effectiveness of non-pharmacological methods in reducing pain during invasive procedures and to investigate the effects of easy-to-apply methods on pain. In light of this information, this study aimed to compare the effect of distraction by using Virtual Reality Glasses, Kaleidoscope and Distraction Cards in reducing pain and anxiety during blood draw in children.
This study is a prospective, randomized and controlled trial. Children aged 7 to 11 years who required blood draw were divided into three groups; Virtual Reality Glasses, Kaleidoscope, Distraction Cards and Control. Data were obtained through face-to-face interviews with the children, their parents, and the observer before and after the procedure. The children's pain levels were assessed and reported by the parents and observers and the children themselves who self-reported using Wong-Baker FACES. The children's anxiety levels were also assessed using the Children's Fear Scale.
The study population consisted of children aged 7 to 11 years who presented to the children's blood draw room of the hospital.
Sample of the study consisted of a total of 400 children who met the sample selection criteria and were selected via randomization method.
Children were randomized into three groups: Virtual Reality Glasses group (n= 100), Kaleidoscope group (n= 100), Distraction Cards group (n= 100) and Control group (n= 100).
Data were collected using the Interview and Observation Form, Wong-Baker FACES Pain Rating Scale, Children's Fear Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Glasses Group | Experimental | Other: Virtual Reality GlassesVirtual Reality(VR) Glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses before starting the application and it continued until the end of the Blood Draw procedure. |
| Kaleidoscope Group | Experimental | Other: KaleidoscopeKaleidoscope were introduced to the children pre-procedure. The children were made to watch Kaleidoscope before starting the application and it continued until the end of the Blood Draw procedure. |
| Distraction Cards Group | Experimental | Other: Distraction CardsDistraction Cards were introduced to the children pre-procedure. The children were made to apply Distraction Cards before starting the application and it continued until the end of the Blood Draw procedure. |
| Control Group | No intervention | –In this group, children received routine blood draw procedure. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children between the ages of 7-11,
- Volunteering of the child and parent to participate in the study,
- Blood draw for routine control purposes,
- Blood draw should be done by the same nurse,
- The needle on which blood draw will be performed must be of the same thickness.
Key exclusion criteria (6 listed)
- The child has any acute or chronic disease,
- The child has a mental disability, vision, speech or communication problems,
- The parent has hearing, vision or verbal communication difficulties,
- The child used analgesics in the last 6 hours,
- Infection, disruption of skin integrity and rash in the area where the application will be made,
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 |
|---|---|---|
| Virtual Reality GlassesVirtual Reality(VR) Glasses were introduced to the children pre-procedure. The children were made to watch a video with VR glasses before starting the application and it continued until the end of the Blood Draw procedure. | Other | Virtual Reality Glasses Group |
| KaleidoscopeKaleidoscope were introduced to the children pre-procedure. The children were made to watch Kaleidoscope before starting the application and it continued until the end of the Blood Draw procedure. | Other | Kaleidoscope Group |
| Distraction CardsDistraction Cards were introduced to the children pre-procedure. The children were made to apply Distraction Cards before starting the application and it continued until the end of the Blood Draw procedure. | Other | Distraction Cards Group |
Primary outcome
Wong-Baker FACES Pain Rating Scale
Time frame: Through painful procedure completion, an average of 10 minutes
In the study, pain level evaluations, the children's self-evaluations, parents' evaluations and the researcher's evaluations were carried out using the WB-FACES scale. This scale was developed by Donna Wong and Connie Morain Baker in 1988. The scale is graded between 0-10 points. A smiling face on the far left symbolizes "no pain" (0 very happy/no pain) and the pain increases from left to right. On the other hand, a crying face on the far right symbolizes "unbearable pain" (10 'hurts worst'). As the numbers increase in this scoring system, facial expressions also change referring to an increase in pain levels.
Children's Fear Scale
Time frame: Through painful procedure completion, an average of 10 minutes
CFS is used for measuring the child's anxiety level. CFS is a scale which makes an evaluation from 0 to 4 consisting of five facial expressions drawn to show expressions that vary from neutral expression (0=no anxiety) to scared face (4=severe anxiety).
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 9 Jan 2024.
- Derived from this study: PubMed 39303378Ates Besirik S, Canbulat Sahiner N. Comparison of the effectiveness of three different distraction methods in reducing pain and anxiety during blood drawing in children: A randomized controlled study. J Pediatr Nurs. 2024 Nov-Dec;79:225-233. doi: 10.1016/j.pedn.2024.09.009. Epub 2024 Sep 19.
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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.
Selda Ateş Beşirik, PhD. principal investigator
Burdur Mehmet Akif Ersoy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Glasses, Kaleidoscope and Distraction Cards in people with Acute Pain and Virtual Reality, run by Burdur Mehmet Akif Ersoy 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 5 inclusion and 6 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 9 Jan 2024. 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?
Wong-Baker FACES Pain Rating Scale (time frame: Through painful procedure completion, an average of 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06192498, which also lists 1 linked publication.
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 9 Jan 2024.