Procedural PainReVaDoNCT03888690
Effect of Virtual Reality Distraction on Procedural Pain for Children and Adolescents in Onco-Hematology Unit.
A study testing Virtual Reality Headset in people with Procedural Pain and Procedural Anxiety, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Demonstrate the effectiveness of the Virtual Reality (VR) distraction on pain reduction in children and adolescents in onco-hematology unit compared to standard practice. Evaluate the impact of VR on the level of anxiety induced by invasive procedures Report traceability of assessment of pain and anxiety scores, and… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Procedural Pain, Procedural Anxiety, Virtual Reality
- What is being tested?
- Virtual Reality Headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 30 Jun 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children or Adolescent supported in onco-hematologic unit.
Who cannot join
- Serious behavioral disorders
- Serious neurosensory deficit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Evaluating the Effectiveness of the Virtual Reality Distraction Compared to Current Practice, on Reducing Procedural Pain in Children and Adolescents Supported in Pediatric Onco-Hematology Unit.
- Demonstrate the effectiveness of the Virtual Reality (VR) distraction on pain reduction in children and adolescents in onco-hematology unit compared to standard practice.
- Evaluate the impact of VR on the level of anxiety induced by invasive procedures
- Report traceability of assessment of pain and anxiety scores, and reproducibility of procedural analgesia techniques.
- Evaluate the impact of VR on the short-term consequences of procedural pain, especially in terms of phobia of care.
Read the detailed description
Diagnosis and therapeutic management of onco-hematological pathologies in children and adolescents require multiple invasive procedures that cause pain and discomfort. These are paramedical procedures (blood sampling on the peripheral vein, placement of infusions, placement of Hubert's needles on an implantable device, ...) and medical procedures (lumbar punctures, medullary punctures, ...).
The short-term (phobia of care) and long-term consequences (memory of pain, behavioral disorders, nociceptive sensitization) are clearly reported in the medical literature, and the importance of thinking about pharmacological and non-pharmacological techniques well-established procedural pain prevention.
The quality of the management of the pain and anxiety induced by these invasive oprocedures in pediatric onco-hematology conditions the adhesion to the care and the treatments, and thus constitutes a challenge in the care of the patients. The non-pharmacological methods are numerous and still insufficiently used by the care teams. Virtual Reality is on interesting option.
- Conditions
- Procedural Pain, Procedural Anxiety, Virtual Reality
- Being tested
- Virtual Reality Headset
- Keywords
- Children, Adolescent, non pharmacological interventions, onco-hematologic
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetDevice
Standardized procedures, with or without Virtual Reality Headset.
| Study group | Role | What they receive |
|---|---|---|
| With and then without VR | Active comparator | Virtual Reality with standardized procedures for first intervention, Standardized procedures for second intervention, without VR. Receives: Device: Virtual Reality Headset |
| Without and then with VR | Active comparator | Standardized procedures without VR for first intervention, Virtual Reality with standardized procedures for second intervention. Receives: Device: Virtual Reality Headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Analogical visual scale
Measured: 1 hour
Secondary outcomes (2)
Anxiety scores
Yale scale
Measured: 1 hour
Traceability of the procedure
Pain management scorecard
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Crossover
- Model description
- Interventional monocentric regional study opened in crossover test with randomization of sequence (sequence 1 "with then without Virtual Reality", sequence 2 "without then with Virtual reality").
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludovic MANSUY, Principal investigator, CHRU NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888690
- Sponsor's protocol ID
- CHRU NANCY
- Acronym
- ReVaDo
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chow CH, Van Lieshout RJ, Schmidt LA, Dobson KG, Buckley N. Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery. J Pediatr Psychol. 2016 Mar;41(2):182-203. doi: 10.1093/jpepsy/jsv094. Epub 2015 Oct 17.
PubMed 26476281Felluga M, Rabach I, Minute M, Montico M, Giorgi R, Lonciari I, Taddio A, Barbi E. A quasi randomized-controlled trial to evaluate the effectiveness of clowntherapy on children's anxiety and pain levels in emergency department. Eur J Pediatr. 2016 May;175(5):645-50. doi: 10.1007/s00431-015-2688-0. Epub 2016 Jan 12.
PubMed 26755209Al-Khotani A, Bello LA, Christidis N. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial. Acta Odontol Scand. 2016 Aug;74(6):494-501. doi: 10.1080/00016357.2016.1206211. Epub 2016 Jul 13.
PubMed 27409593Aydin D, Sahiner NC, Ciftci EK. Comparison of the effectiveness of three different methods in decreasing pain during venipuncture in children: ball squeezing, balloon inflating and distraction cards. J Clin Nurs. 2016 Aug;25(15-16):2328-35. doi: 10.1111/jocn.13321. Epub 2016 Apr 26.
PubMed 27112434
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Evaluating the Effectiveness of the Virtual Reality Distraction Compared to Current Practice, on Reducing Procedural Pain in Children and Adolescents Supported in Pediatric Onco-Hematology Unit.
- ClinicalTrials.gov ID
- NCT03888690
- Acronym / sponsor ID
- ReVaDo / CHRU NANCY
- Conditions
- Procedural Pain, Procedural Anxiety, Virtual Reality
- Keywords
- Children, Adolescent, non pharmacological interventions, onco-hematologic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 25 Mar 2019 (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.
- Demonstrate the effectiveness of the Virtual Reality (VR) distraction on pain reduction in children and adolescents in onco-hematology unit compared to standard practice.
- Evaluate the impact of VR on the level of anxiety induced by invasive procedures
- Report traceability of assessment of pain and anxiety scores, and reproducibility of procedural analgesia techniques.
- Evaluate the impact of VR on the short-term consequences of procedural pain, especially in terms of phobia of care.
Detailed description
Diagnosis and therapeutic management of onco-hematological pathologies in children and adolescents require multiple invasive procedures that cause pain and discomfort. These are paramedical procedures (blood sampling on the peripheral vein, placement of infusions, placement of Hubert's needles on an implantable device, ...) and medical procedures (lumbar punctures, medullary punctures, ...).
The short-term (phobia of care) and long-term consequences (memory of pain, behavioral disorders, nociceptive sensitization) are clearly reported in the medical literature, and the importance of thinking about pharmacological and non-pharmacological techniques well-established procedural pain prevention.
The quality of the management of the pain and anxiety induced by these invasive oprocedures in pediatric onco-hematology conditions the adhesion to the care and the treatments, and thus constitutes a challenge in the care of the patients. The non-pharmacological methods are numerous and still insufficiently used by the care teams. Virtual Reality is on interesting option.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional monocentric regional study opened in crossover test with randomization of sequence (sequence 1 "with then without Virtual Reality", sequence 2 "without then with Virtual reality").
| Arm | Type | Receives |
|---|---|---|
| With and then without VR | Active comparator | Device: Virtual Reality HeadsetVirtual Reality with standardized procedures for first intervention, Standardized procedures for second intervention, without VR. |
| Without and then with VR | Active comparator | Device: Virtual Reality HeadsetStandardized procedures without VR for first intervention, Virtual Reality with standardized procedures for second intervention. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children or Adolescent supported in onco-hematologic unit.
Key exclusion criteria (2 listed)
- Serious behavioral disorders
- Serious neurosensory deficit
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 HeadsetStandardized procedures, with or without Virtual Reality Headset. | Device | With and then without VR, Without and then with VR |
Primary outcome
Pain scores
Time frame: 1 hour
Analogical visual scale
2 secondary outcomes
Anxiety scores
Time frame: 1 hour
Traceability of the procedure
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Background: PubMed 26476281Chow CH, Van Lieshout RJ, Schmidt LA, Dobson KG, Buckley N. Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery. J Pediatr Psychol. 2016 Mar;41(2):182-203. doi: 10.1093/jpepsy/jsv094. Epub 2015 Oct 17.
- Results publication: PubMed 26755209Felluga M, Rabach I, Minute M, Montico M, Giorgi R, Lonciari I, Taddio A, Barbi E. A quasi randomized-controlled trial to evaluate the effectiveness of clowntherapy on children's anxiety and pain levels in emergency department. Eur J Pediatr. 2016 May;175(5):645-50. doi: 10.1007/s00431-015-2688-0. Epub 2016 Jan 12.
- Results publication: PubMed 27409593Al-Khotani A, Bello LA, Christidis N. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial. Acta Odontol Scand. 2016 Aug;74(6):494-501. doi: 10.1080/00016357.2016.1206211. Epub 2016 Jul 13.
- Results publication: PubMed 27112434Aydin D, Sahiner NC, Ciftci EK. Comparison of the effectiveness of three different methods in decreasing pain during venipuncture in children: ball squeezing, balloon inflating and distraction cards. J Clin Nurs. 2016 Aug;25(15-16):2328-35. doi: 10.1111/jocn.13321. Epub 2016 Apr 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.
Ludovic MANSUY principal investigator
CHRU NANCY
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 Headset in people with Procedural Pain and Procedural Anxiety, run by Central Hospital, Nancy, France at 1 site in France.
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 1 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: status not confirmed, as of the sponsor's last update on 25 Mar 2019. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle PEROT (03-83-15-46-31, isaperot@orange.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: 1 hour). 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 NCT03888690, which also lists 4 linked publications.
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 25 Mar 2019.