Pediatric CancerNCT06235723
Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic
A study testing Virtual Reality in people with Pediatric Cancer and Procedural Anxiety, run by Hannover Medical School at 1 site in Germany.
Trial summary
Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain reduction by virtual reality (VR) during port and vein punctures is well studied. This study investigates peri-interventional reduction of pain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pediatric Cancer, Procedural Anxiety, Procedural Pain
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2021to 20 Dec 2023
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged 6-18 years
- any sex
- port puncture or placement of a peripheral venous catheter in pediatric outpatient clinic
- hematological or oncological diagnosis
- informed consent
Who cannot join
- epilepsy
- coronary artery disease
- history of severe vertigo
- obstacles to putting on and wearing VR glasses
- lack of informed consent for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic: a Randomized Controlled Trial
Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain reduction by virtual reality (VR) during port and vein punctures is well studied. This study investigates peri-interventional reduction of pain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric oncology outpatient clinic.
In a randomized, controlled cross-over design, patients aged 6-18 years experience potentially painful interventions accompanied by VR. All patients included in the study underwent port puncture or peripheral venous puncture in two observations : SOC (A) and VR (B) in a randomized order. Observational instruments include Numeral Rating Scale (NRS), Faces Pain Scale revised (FPS-r), Behavioral Approach Avoidance Distress Scale (BAADS), modified Yale Preoperative Anxiety Scale (mYPAS-SF). In addition, parents and staff are interviewed. Specific conditions for VR in an outpatient clinic setting are being discussed.
- Conditions
- Pediatric Cancer, Procedural Anxiety, Procedural Pain
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Pediatric Oncoloy, Outpatient Clinic, Peri-interventional Pain
- Medical subject headings
- Neoplasms, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Virtual Reality was used before and during punctures. For every observation patients underwent either port puncture or peripheral venous puncture. One examination was carried out according to the Standard-of-Care. The other one was carried out with the additional use of VR. Participants watched a passive distraction video.
| Study group | Role | What they receive |
|---|---|---|
| SOC (A) | No intervention | SOC = Standard-of-Care |
| VR (B) | Experimental | VR = Virtual Reality Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Pain measured with Numeric Rating Scale (NRS; scale 0-10; higher score stating higher levels of pain)
Virtual Reality vs. Standard-of-Care
Measured: pre-, peri-, post-interventional (before puncture when entering intervention room, during puncture and 5 minutes after puncture)
Procedural Anxiety measured with modified Yale Preoperative Anxiety Scale (mYPAS-SF; scale 23-100; higher score stating higher levels of anxiety)
Virtual Reality vs. Standard-of-Care
Measured: pre-, peri-interventional (before puncture when entering intervention room and during puncture)
Procedural Distress measured with Behavioral Approach Avoidance Distress Scale (BAADS; scale 0-10; higher score stating higher levels of distress)
Virtual Reality vs. Standard-of-Care
Measured: pre-, peri-interventional (before puncture when entering intervention room and during puncture)
Secondary outcomes (2)
Acceptance of VR in pediatric procedures (questionnaire using a 5-point-likert-scale)
Parents and patients were given different statements
Measured: post-interventional (immediately after the intervention)
Implementation factors for VR in pediatric outpatient clinics (qualitive questionnaire)
Involved staff were asked about experience/feedback
Measured: through study completion, ~ 1.5 years in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Jul 2021
- Primary completion20 Dec 2022
- Study completion20 Dec 2023
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 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urs Mücke, Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235723
- Sponsor's protocol ID
- VirtualReality2023
- Status last verified
- Feb 2024
- First submitted
- 23 Dec 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reitze A, Voigt M, Klawonn F, Dusch M, Grigull L, Mucke U. Impact of virtual reality on peri-interventional pain, anxiety and distress in a pediatric oncology outpatient clinic: a randomized controlled trial. BMC Pediatr. 2024 Aug 3;24(1):501. doi: 10.1186/s12887-024-04952-3.
PubMed 39097718
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06235723
- Acronym / sponsor ID
- VirtualReality2023
- Conditions
- Pediatric Cancer, Procedural Anxiety, Procedural Pain
- Keywords
- Virtual Reality, Pediatric Oncoloy, Outpatient Clinic, Peri-interventional Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 1 Feb 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.
Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain reduction by virtual reality (VR) during port and vein punctures is well studied. This study investigates peri-interventional reduction of pain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric oncology outpatient clinic.
In a randomized, controlled cross-over design, patients aged 6-18 years experience potentially painful interventions accompanied by VR. All patients included in the study underwent port puncture or peripheral venous puncture in two observations : SOC (A) and VR (B) in a randomized order. Observational instruments include Numeral Rating Scale (NRS), Faces Pain Scale revised (FPS-r), Behavioral Approach Avoidance Distress Scale (BAADS), modified Yale Preoperative Anxiety Scale (mYPAS-SF). In addition, parents and staff are interviewed. Specific conditions for VR in an outpatient clinic setting are being discussed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC (A) | No intervention | –SOC = Standard-of-Care |
| VR (B) | Experimental | Device: Virtual RealityVR = Virtual Reality |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- aged 6-18 years
- any sex
- port puncture or placement of a peripheral venous catheter in pediatric outpatient clinic
- hematological or oncological diagnosis
- informed consent
Key exclusion criteria (5 listed)
- epilepsy
- coronary artery disease
- history of severe vertigo
- obstacles to putting on and wearing VR glasses
- lack of informed consent for study participation.
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 was used before and during punctures. For every observation patients underwent either port puncture or peripheral venous puncture. One examination was carried out according to the Standard-of-Care. The other one was carried out with the additional use of VR. Participants watched a passive distraction video. | Device | VR (B) |
Primary outcome
Procedural Pain measured with Numeric Rating Scale (NRS; scale 0-10; higher score stating higher levels of pain)
Time frame: pre-, peri-, post-interventional (before puncture when entering intervention room, during puncture and 5 minutes after puncture)
Virtual Reality vs. Standard-of-Care
Procedural Anxiety measured with modified Yale Preoperative Anxiety Scale (mYPAS-SF; scale 23-100; higher score stating higher levels of anxiety)
Time frame: pre-, peri-interventional (before puncture when entering intervention room and during puncture)
Virtual Reality vs. Standard-of-Care
Procedural Distress measured with Behavioral Approach Avoidance Distress Scale (BAADS; scale 0-10; higher score stating higher levels of distress)
Time frame: pre-, peri-interventional (before puncture when entering intervention room and during puncture)
Virtual Reality vs. Standard-of-Care
2 secondary outcomes
Acceptance of VR in pediatric procedures (questionnaire using a 5-point-likert-scale)
Time frame: post-interventional (immediately after the intervention)
Implementation factors for VR in pediatric outpatient clinics (qualitive questionnaire)
Time frame: through study completion, ~ 1.5 years in total
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 13 Feb 2024.
- Derived from this study: PubMed 39097718Reitze A, Voigt M, Klawonn F, Dusch M, Grigull L, Mucke U. Impact of virtual reality on peri-interventional pain, anxiety and distress in a pediatric oncology outpatient clinic: a randomized controlled trial. BMC Pediatr. 2024 Aug 3;24(1):501. doi: 10.1186/s12887-024-04952-3.
- 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.
Urs Mücke, Dr. principal investigator
Hannover Medical School
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 and Procedural Anxiety, run by Hannover Medical School at 1 site in Germany.
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 5 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 13 Feb 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 Germany. 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?
Procedural Pain measured with Numeric Rating Scale (NRS; scale 0-10; higher score stating higher levels of pain) (time frame: pre-, peri-, post-interventional (before puncture when entering intervention room, during puncture and 5 minutes after puncture)). 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 NCT06235723, 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 13 Feb 2024.