Virtual RealityVR-PHONCT05675358
Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients
A study testing Virtual Reality in people with Virtual Reality and Pain, Acute, run by Dokuz Eylul University at 2 sites in Turkey (Türkiye).
Trial summary
In this study, the effect of virtual reality, which is one of the pain relief methods, on the pain, fear and emotional appearance associated with the procedure, was evaluated in children aged 4-12 years who will undergo phelobotomy in a Pediatric Hematology and Oncology outpatient clinic. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Virtual Reality, Pain, Acute, Pediatric Cancer
- What is being tested?
- Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Mar 2022to 3 Sep 2022
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- the age range is between 4-12
- to apply to the pediatric hematology and oncology outpatient clinic and to have blood taken
- consent of the child and parent to voluntarily participate in the study
- The child does not have a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality.
Who cannot join
- having a fever (>37.5C) and severe dehydration
- Before the invasive procedure, the patient was given anagesics.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Gülçin Özalp Gerçeker
Izmir, 35100
Gülçin Özalp Gerçeker
Izmir
About this study
In this study, the effect of virtual reality, which is one of the pain relief methods, on the pain, fear and emotional appearance associated with the procedure, was evaluated in children aged 4-12 years who will undergo phelobotomy in a Pediatric Hematology and Oncology outpatient clinic.
Read the detailed description
This prospective randomized controlled study was conducted in the pediatric hematology and oncology polyclinic blood collection unit of a university hospital in Turkey.
Patients undergoing phelobotomy were allocated to virtual reality or control groups according to a stratified randomization scheme.
- Conditions
- Virtual Reality, Pain, Acute, Pediatric Cancer
- Being tested
- Virtual Reality
- Keywords
- virtual reality, phlebotomy, pain, fear, anxiety, emotional apperance
- Medical subject headings
- Acute Pain, Neoplasms, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
Oculus Quest 2 256 GB All-In-One Vr Virtual Reality Glasses were used in the study.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | In the study, Oculus Quest 2 256 GB All-In-One Vr Virtual Reality Glasses were used, and the Epic Roller Coasters train game, an application that would attract the attention of children, was determined by the researchers. The virtual reality application was started 2 minutes before the procedure and continued until the procedure was completed. Receives: Behavioral: Virtual Reality |
| control | No intervention | The child in the control group did not receive any additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assesed by 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
Measured: procedure - during the phelobotomy
Fear assesed by Child Fear Scale
The Child Fear Scale (CFS), this one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear.
Measured: procedure -during the phelobotomy
Anxiety assesed by Children Anxiety Meter-State
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10).
Measured: procedure- during the phelobotomy
Secondary outcomes (1)
emotional apperance assesed by Emotional Appearance Scale for Children
This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'.
Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5.
Measured: Baseline - before the phelobotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start3 Mar 2022
- Primary completion3 Aug 2022
- Study completion3 Sep 2022
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 Virtual RealityStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- Afyonkarahisar Health Sciences University
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Gülçin Özalp Gerçeker, pHD, RN, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675358
- Sponsor's protocol ID
- ASBU 2022/89
- Acronym
- VR-PHO
- Status last verified
- Dec 2022
- First submitted
- 29 Dec 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kanad N, Ozalp Gerceker G, Eker I, Sen Susam H. The effect of virtual reality on pain, fear and emotional appearance during blood draw in pediatric patients at the hematology-oncology outpatient clinic: A randomized controlled study. Eur J Oncol Nurs. 2024 Feb;68:102495. doi: 10.1016/j.ejon.2023.102495. Epub 2023 Dec 26.
PubMed 38184927
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients
- ClinicalTrials.gov ID
- NCT05675358
- Acronym / sponsor ID
- VR-PHO / ASBU 2022/89
- Conditions
- Virtual Reality, Pain, Acute, Pediatric Cancer
- Keywords
- virtual reality, phlebotomy, pain, fear, anxiety, emotional apperance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Afyonkarahisar Health Sciences University
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Sep 2022 (actual)
- First posted
- 9 Jan 2023 (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 this study, the effect of virtual reality, which is one of the pain relief methods, on the pain, fear and emotional appearance associated with the procedure, was evaluated in children aged 4-12 years who will undergo phelobotomy in a Pediatric Hematology and Oncology outpatient clinic.
Detailed description
This prospective randomized controlled study was conducted in the pediatric hematology and oncology polyclinic blood collection unit of a university hospital in Turkey.
Patients undergoing phelobotomy were allocated to virtual reality or control groups according to a stratified randomization scheme.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Behavioral: Virtual RealityIn the study, Oculus Quest 2 256 GB All-In-One Vr Virtual Reality Glasses were used, and the Epic Roller Coasters train game, an application that would attract the attention of children, was determined by the researchers. The virtual reality application was started 2 minutes before the procedure and continued until the procedure was completed. |
| control | No intervention | –The child in the control group did not receive any additional intervention. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- the age range is between 4-12
- to apply to the pediatric hematology and oncology outpatient clinic and to have blood taken
- consent of the child and parent to voluntarily participate in the study
- The child does not have a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality.
Key exclusion criteria (2 listed)
- having a fever (>37.5C) and severe dehydration
- Before the invasive procedure, the patient was given anagesics.
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 RealityOculus Quest 2 256 GB All-In-One Vr Virtual Reality Glasses were used in the study. | Behavioural | virtual reality |
Primary outcome
Pain assesed by Wong-Baker FACES
Time frame: procedure - during the phelobotomy
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
Fear assesed by Child Fear Scale
Time frame: procedure -during the phelobotomy
The Child Fear Scale (CFS), this one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear.
Anxiety assesed by Children Anxiety Meter-State
Time frame: procedure- during the phelobotomy
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10).
1 secondary outcome
emotional apperance assesed by Emotional Appearance Scale for Children
Time frame: Baseline - before the phelobotomy
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 2023.
- Derived from this study: PubMed 38184927Kanad N, Ozalp Gerceker G, Eker I, Sen Susam H. The effect of virtual reality on pain, fear and emotional appearance during blood draw in pediatric patients at the hematology-oncology outpatient clinic: A randomized controlled study. Eur J Oncol Nurs. 2024 Feb;68:102495. doi: 10.1016/j.ejon.2023.102495. Epub 2023 Dec 26.
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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.
Gülçin Özalp Gerçeker, pHD, RN principal investigator
Dokuz Eylul University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Virtual Reality and Pain, Acute, run by Dokuz Eylul University at 2 sites 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 2 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 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Wong-Baker FACES (time frame: procedure - during the phelobotomy). 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?
On the ClinicalTrials.gov record for NCT05675358, 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 2023.