Pediatric CancerNCT06605339
Virtual Reality on Pain, Fear and Emotional Experience During Port Needle Insertion
A study testing Virtual Reality in people with Pediatric Cancer, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
In pediatric hematology-oncology patients, the need for a central venous catheter may arise in some cases to provide treatment. Totally implanted vascular access devices are known as "ports," and port catheters are commonly used due to their lower risk of infection. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- 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
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 30 Dec 2024
- 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 child having a port catheter in place.
- The child agreeing to voluntarily participate in the study.
- The parent agreeing to voluntarily participate in the study.
- Obtaining consent forms from both the child and the parent.
Who cannot join
- The child had a physical or psychological deficits that would prevent the child from wearing the headset needed to watch virtual reality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality on Pain, Fear and Emotional Experience During Port Needle Insertion in Pediatric Hematology and Oncology Patients
In pediatric hematology-oncology patients, the need for a central venous catheter may arise in some cases to provide treatment. Totally implanted vascular access devices are known as "ports," and port catheters are commonly used due to their lower risk of infection. To maintain the port system and prevent infection, the port needle should be replaced every 5-7 days. During the course of treatment, pediatric hematology-oncology patients undergo frequently repeated procedures associated with high levels of pain and distress. Pain and distress resulting from repeated procedures are often uncomfortable symptoms for pediatric patients and their families. There are pharmacological and non-pharmacological methods to reduce pain and anxiety during port needle procedures in pediatric hematology-oncology patients. One pharmacological method, distraction, increases pain tolerance by focusing attention away from the painful stimulus. This technique is used as a powerful tool for pain and anxiety management in pediatric pain. Virtual reality glasses, used as a distraction method, provide access to an interactive, three-dimensional, computer-simulated environment through a head-mounted device that blocks out real-world views. It is stated that distraction with virtual reality is a beneficial non-pharmacological method for children during hospital-based needle applications for pediatric patients. This study evaluated the effect of virtual reality on pain, fear, and emotional appearance related to needle procedures in pediatric hematology-oncology patients during port needle changes.
Read the detailed description
The study was conducted at the Pediatric Hematology and Oncology Clinic of Afyonkarahisar Health Sciences University Health Practice and Research Center.
Research Hypotheses:
H1: There is a difference in pain and fear scores among patients who watch videos using virtual reality glasses during port needle changes.
H2: There is a difference in emotional appearance scores among patients who watch videos using virtual reality glasses during port needle changes.
Randomization:
A stratified randomization scheme was used for distributing the sample into groups. Stratification was done based on gender (female, male), age group (4-7, 8-12), and port duration (<1 month, >1 month).
Patients requiring port needle changes were assigned to groups according to the randomization scheme. No additional intervention was made for patients in the control group; they were observed during the procedure after obtaining consent. Patients in the study group were introduced to the virtual headset and informed that they could watch a video using the virtual reality headset during the procedure. The "Epic Roller Coasters" video game was initiated. If the child wanted to remove the glasses during the procedure, they were excluded from the study. Before the procedure, the fear score was determined by asking both the patient and the parent using the Children's Fear Scale. After the procedure, the pain levels were evaluated independently by the child, the mother, the attending nurse, and the researcher. Following the intervention, the child's emotional appearance was assessed by the nurse.
- Conditions
- Pediatric Cancer
- Being tested
- Virtual Reality
- Keywords
- pediatric, cancer, virtual reality, pain, fear, emotional behavior
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
Virtual Reality Distraction
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The child in the control group did not receive any additional intervention. |
| 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 |
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: after the port needle insertion
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: after the port needle insertion
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: after the port needle insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Mar 2022
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies 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
- Investigator
- Enrolment
- 50 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
- Gulcin Ozalp Gerceker, Assoc. Prof., Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605339
- Sponsor's protocol ID
- ASBU portVR
- Status last verified
- Mar 2025
- First submitted
- 18 Sep 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality on Pain, Fear and Emotional Experience During Port Needle Insertion in Pediatric Hematology and Oncology Patients
- ClinicalTrials.gov ID
- NCT06605339
- Acronym / sponsor ID
- ASBU portVR
- Conditions
- Pediatric Cancer
- Keywords
- pediatric, cancer, virtual reality, pain, fear, emotional behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Afyonkarahisar Health Sciences University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 20 Sep 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.
In pediatric hematology-oncology patients, the need for a central venous catheter may arise in some cases to provide treatment. Totally implanted vascular access devices are known as "ports," and port catheters are commonly used due to their lower risk of infection. To maintain the port system and prevent infection, the port needle should be replaced every 5-7 days. During the course of treatment, pediatric hematology-oncology patients undergo frequently repeated procedures associated with high levels of pain and distress. Pain and distress resulting from repeated procedures are often uncomfortable symptoms for pediatric patients and their families. There are pharmacological and non-pharmacological methods to reduce pain and anxiety during port needle procedures in pediatric hematology-oncology patients. One pharmacological method, distraction, increases pain tolerance by focusing attention away from the painful stimulus. This technique is used as a powerful tool for pain and anxiety management in pediatric pain. Virtual reality glasses, used as a distraction method, provide access to an interactive, three-dimensional, computer-simulated environment through a head-mounted device that blocks out real-world views. It is stated that distraction with virtual reality is a beneficial non-pharmacological method for children during hospital-based needle applications for pediatric patients. This study evaluated the effect of virtual reality on pain, fear, and emotional appearance related to needle procedures in pediatric hematology-oncology patients during port needle changes.
Detailed description
The study was conducted at the Pediatric Hematology and Oncology Clinic of Afyonkarahisar Health Sciences University Health Practice and Research Center.
Research Hypotheses:
H1: There is a difference in pain and fear scores among patients who watch videos using virtual reality glasses during port needle changes.
H2: There is a difference in emotional appearance scores among patients who watch videos using virtual reality glasses during port needle changes.
Randomization:
A stratified randomization scheme was used for distributing the sample into groups. Stratification was done based on gender (female, male), age group (4-7, 8-12), and port duration (<1 month, >1 month).
Patients requiring port needle changes were assigned to groups according to the randomization scheme. No additional intervention was made for patients in the control group; they were observed during the procedure after obtaining consent. Patients in the study group were introduced to the virtual headset and informed that they could watch a video using the virtual reality headset during the procedure. The "Epic Roller Coasters" video game was initiated. If the child wanted to remove the glasses during the procedure, they were excluded from the study. Before the procedure, the fear score was determined by asking both the patient and the parent using the Children's Fear Scale. After the procedure, the pain levels were evaluated independently by the child, the mother, the attending nurse, and the researcher. Following the intervention, the child's emotional appearance was assessed by the nurse.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The child in the control group did not receive any additional intervention. |
| 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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The child having a port catheter in place.
- The child agreeing to voluntarily participate in the study.
- The parent agreeing to voluntarily participate in the study.
- Obtaining consent forms from both the child and the parent.
Key exclusion criteria (1 listed)
- The child had a physical or psychological deficits that would prevent the child from wearing the headset needed to watch virtual reality
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 RealityVirtual Reality Distraction | Behavioural | Virtual reality |
Primary outcome
Pain assesed by Wong-Baker FACES
Time frame: after the port needle insertion
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: after the port needle insertion
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.
emotional apperance assesed by Emotional Appearance Scale for Children
Time frame: after the port needle insertion
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.
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 19 Mar 2025.
- 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.
Gulcin Ozalp Gerceker, Assoc. Prof. principal investigator
Dokuz Eylul 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 in people with Pediatric Cancer, run by Dokuz Eylul 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 1 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 19 Mar 2025. 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 Wong-Baker FACES (time frame: after the port needle insertion). 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 19 Mar 2025.