Reitze et al. BMC Pediatrics(2024) 24:501
https://doi.org/10.1186/s12887-024-04952-3

BMC Pediatrics

RESEARCH

Open Access

Impact of virtual reality on peri-interventional
pain, anxiety and distress in a pediatriconcology outpatient clinic: a randomized
controlled trial
Alicia Reitze1, Marie Voigt1, Frank Klawonn2,3, Martin Dusch4, Lorenz Grigull5 and Urs Mücke1*
Abstract
Purpose 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 ofpain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric oncology outpatient clinic.
Methods In a randomized, controlled cross-over design, patients aged 6–18 years experience potentially painfulinterventions accompanied by VR. Observational instruments include NRS, FPS-r, BAADS, mYPAS-SF, PedsQL and
SSKJ3-8R. All patients undergo two observations: SOC (A) and VR (B) in a randomized order. In addition, parents andstaff are interviewed. Specific conditions for VR in an outpatient clinic setting derived from interprofessional focus
group discussion are being explored.
Results Between July 2021 and December 2022 57 eligible patients were included and randomized to the orders A/B(n = 28) and B/A (n = 29). Thirty-eight patients completed both observations. Characteristics in both groups did not
differ significantly. More than half of the patients had no previous experience with VR, 5% decided to discontinue VR
prematurely. Peri-interventional pain, anxiety and distress were significantly reduced by VR compared with SOC. 71%
of patients and 76% of parents perceived punctures with VR to be more relaxed than previous ones. 95% of patients
perceived fun with VR goggles. Detailed questionnaires on individual stress and anxiety were returned from 26 of 38
patients. Focus group discussion with staff yielded evidence for successful implementation of VR in an outpatient
clinic.
Conclusions The present study shows that VR can be used for peri-interventional reduction of pain, anxiety, anddistress in the special environment of a pediatric outpatient clinic. Specific conditions must be met for successful
implementation. Further studies are needed to identify particularly susceptible patients and to illuminate alternatives
for distraction that are feasible to implement with limited resources.
Trial registration number (ClinicalTrials.gov ID): NCT06235723; 01/02/2024; retrospectively registered. This study
adheres to the standard checklist of CONSORT guidelines.

*Correspondence:
Urs Mücke
muecke.urs@mh-hannover.de
Full list of author information is available at the end of the article© The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use,sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) andthe source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in thisarticle are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not includedin the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you willneed to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The
Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available
in this article, unless otherwise stated in a credit line to the data.

Reitze et al. BMC Pediatrics(2024) 24:501

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Key messages
What is known• Interventions in pediatrics cause anxiety, distress and pain.
• Pain-reducing methods require specific conditions in the context of an outpatient clinic.
• Virtual reality has the potential to reduce anxiety and pain in addition to other methods.
What is new• VR enjoys great popularity among pediatric oncology patients, parents, and staff.
• Self- and peer-assessment tools for pain, anxiety, and stress can be used for intra- and inter-individual comparison.
• For the implementation of VR to succeed in an outpatient clinic, specific conditions need to be taken into
account.
• Questionnaires could be used to identify particularly susceptible patients in advance.
Keywords Virtual reality, Pediatric oncology, Outpatient clinic, Peri-interventional pain

Introduction
Potentially painful and stressful interventions limit quality of life in pediatrics. Especially in pediatric oncology,
invasive procedures such as lumbar and bone marrow
punctures occur regularly as part of diagnosis and therapy. Particularly in the case of leukemia, which accounts
for about one-third of all childhood cancers, regularpunctures are part of the patients’ everyday life [1]. Also,
for hematological diseases punctures must be performed
frequently. Standard approaches such as local anesthetic
cream and analgesia can help reduce pain, but they do
not affect anxiety and distress directly. Peri-interventional effective methods are often lacking. Reasons are,for example, lack of personnel, insufficient training,
ignorance of possibilities, lack of technical prerequisites,
time and knowledge about individual needs, and deficits in interprofessional cooperation [2]. Distraction as amethod of stress and pain reduction is often known andattempted through conversation, smartphones, or books[3]. While virtual reality (VR) has been investigated forpain reduction e.g. in wound care and intravenous access,there is a lack of evidence on the effect of VR in the specific setting of an oncology outpatient clinic and thenecessary conditions for its application [4, 5]. In particular, studies on susceptible patients considering adverse
effects and necessary implementation steps in resourcelimited settings are relevant. The results and methodological quality of previous studies on VR in pediatriconcology are heterogeneous. Recent work suggests thepotential of VR as a complementary intervention [6].
In this study, we compare the peri-interventional use of
VR with the individual standard of care (SOC) in termsof reduction in pain, anxiety and distress. Additionally,observations from patients’, parents’ and staffs’ perspective are discussed concerning successful implementation.

Materials and methods
Study design and sample

The present study was a monocentric, prospective, randomized, open-label, cross-over investigation. It was
conducted at Hannover Medical School from July 2021 to
December 2022.
Patients aged 6–18 years, regardless of sex, who underwent a painful puncture (port puncture/placement of aperipheral venous catheter) or a stressful intervention(lumbar puncture/bone marrow puncture) using their
Broviac catheter, were included. Patients without a painful puncture were included in all analyses except for theassessment of pain levels. Detailed informed consent was
obtained from patients and guardians for study participation. Exclusion criteria were epilepsy, coronary arterydisease, history of severe vertigo, obstacles to putting on
and wearing VR glasses, and lack of informed consent
for study participation. Review of inclusion and exclusion criteria was performed by the study team during theweek prior to each appointment at the outpatient clinic.
The study was approved by the local ethics committee.
Study setting

The setting of the study represents a pediatric oncology outpatient clinic where patients are examined andundergo punctures or other potential painful proceduresin an intervention room. The treatment is provided bynursing staff and physicians of different levels of experience. Depending on the number of patients and workload, the opportunities to provide detailed guidance topatients vary widely in terms of individual stress andanxiety reduction. There are other known technical possibilities for distraction besides VR such as the use ofsmartphones.
Randomization

Sample size calculation was based on the WilcoxonMann-Whitney test. The calculation was performed with

Reitze et al. BMC Pediatrics(2024) 24:501

a defensively rounded effect size of 0.8 [7], an α-error of
0.05, and a power of 0.95. This resulted in a sample sizeof n = 37 per group. After consent was obtained, patientswere randomized into an order for use of the distraction
methods. Thus, patients received distraction by VR periinterventionally (B), then according to their standard ofcare (A), or in reverse order (A/B).
Virtual reality

Virtual reality was applied with the help of goggles. These
were demonstrated to the patients, then put on after
entering the room. Patients were able to choose between
three passive distraction videos. Active application (e.g.
games) was not used due to the necessary interventions avoiding sudden movements. The goggles could betaken off at any time. The time of VR usage, reasons forany discontinuation, and further adverse reactions were
documented.
Standard of care

The individual standard of care was determined by thepatients themselves. In addition to the choice of distraction method, this also included the optional use of local
anesthetic cream on the potential puncture site for port
or vein puncture. The respective choice was documented.
Detailed observations on individually selected methods
during the pre-interventional waiting period were notrecorded.
Data collection and assessment tools

Demographic data and prior experience information
were collected prior to the first intervention. Specificaspects of stress management and health related qualityof life were collected with help of SSKJ3-8R and PedsQL[8–10]. Different tools for assessing pain, anxiety, anddistress were used before, during, and after the painfulinterventions. Specifically, the following tools were used:
NRS (for patients of ten years and older) and FPS-r (forpatients of nine years and younger) for the assessmentof pain, mYPAS-SF for the measurement of anxiety and
BAADS for distress assessment [11–14]. After the intervention, assessments of enjoyment, likelihood of repetition, and observations of use by parents and staff wererecorded. After data collection was finished an interprofessional focus group with involved staff members wasused to facilitate conditions for successful implementation of VR. The five participants (nurses and doctors)
were asked to describe their experiences with VR during the study. Afterwards, they were asked to share anddiscuss personal tips that would be helpful for successful implementation. The discussion was moderated by aninvestigator and summarized based on the 10 tips formulated by consensus.

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Data analysis

Data preparation and analysis were performed with SPSS
version 27 and R version 4.2.3. Characteristics of thestudy population were described through methods ofdescriptive statistics. Comparison of groups was carriedout with the t-test for independent samples.

Results
During the study period, 88 patients were contacted andscreened for inclusion (see Fig. 1). Fifty-seven of the eligible patients (65%) could be included. Thirty (34%)
declined to participate. Mainly this was due to a lack ofinterest in or fear concerning VR. After randomization
into the sequence A/B (n = 28 ; SOC first, VR second)or B/A (n = 29 ; VR first, SOC second) 17/28 (61%) and21/29 (72%) could be analyzed. 19/57 (33%) were notincluded in the final analysis as drop-outs or lost-tofollow-up. Reasons for refusal to participate in the study
were documented (health reasons, no interest in glasses
and/or study, Fear of glasses in intervention context, no
problem with anxiety/pain, difficult conditions due tolanguage barriers, finding an appointment for informed
consent and observation). Uncertainty about the use of
VR during a puncture, lack of interest in the study, or
health reasons (worsening of health) were primary concerns here.
Demographics

Out of the 38 patients evaluated after completed crossover, 50% were male and 50% were female (see Table 1).
The average patient age was 11.5 years with a range of
6–18 years. The most common underlying diseases wereleukemia (26%) and thalassemia (29%). The catheters
used for the intervention were predominantly port catheters (55%). Patches with local anesthetics were used by
53% of the patients before skin punctures, whereas mostof them were undergoing a port puncture (see Table 1).
Characteristics such as age, sex or disease were similar
for patients who declined study participation (data notshown).
Peri-interventional use of VR and adverse events

76% of the patients chose to wear the VR glasses for theentire duration of the procedure, including both preparation and the puncture itself. The remaining 24% opted
to use the VR glasses only during the preparation phase,removing them once the staff had prepared everything
for the puncture. The time spent wearing the VR glasses
varied depending on the individual treatment procedures, with some patients wearing them for as little as
2 min and in very few cases of bloodletting for up to
60 min, averaging at around 11 min. Adverse eventsoccurred only rarely during use of the VR goggles. There
were no side effects in almost 90% of the cases. AroundReitze et al. BMC Pediatrics(2024) 24:501

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Fig. 1 Participant flow diagram of all primarily assessed patients

Table 1 Demographic and disease characteristics of the finallyanalyzed participants (n = 38)
Average age (median age) in years
Sex• Male• Female
Disease• Leukemia• Central nervous tumor• Lymphoma• Bone tumor• Other tumor• Thalassemia• Other anaemia
Catheter used for intervention• Port catheter• Peripheral intravenous catheter• Broviac catheter
Analgesia: use of local anesthetic cream in total• Port puncture with local anesthetic cream• Peripheral vein puncture with local anesthetic creamn (%)
11.5 (12.0)
19 (50%)19 (50%)10 (26%)3 (8%)
3 (8%)
2 (5%)
5 (13%)
11 (29%)4 (11%)
21 (55%)15 (40%)2 (5%)
20/38 (53%)
16/21 (76%)
4/15 (27%)

5% of the patients decided to discontinue the VR goggles prematurely due to discomfort. In individual cases,
slight dizziness and nausea were reported, which, however, could not be attributed directly to the use of the VR
goggles.
Previous experience and stress management

Patients were asked about their previous experienceswith the painful puncture and VR before taking part in
the study. This was measured with the help of a 5-point

likert scale. The experiences with the painful intervention were predominantly neither good nor bad. Figure 2
shows that the majority of study participants had similar
attitudes towards painful punctures before taking part in
the study. Most of the patients (61%) didn’t have any previous experience with VR. Previous distraction methods
used were predominantly “none” (63%), the use of smartphone or tablet (18%) and distraction by parents (16%).
Off the detailed survey forms issued (self-report), 26
were returned. In terms of stress vulnerability, the majority of the SSKJ questionnaire showed average stress experience. Individual patients showed an above-average(very vulnerable) or below-average (very resilient) stressexperience.
Peri-interventional pain outcomes

Pain levels were documented before, during and after the
potential painful intervention using FPS-r (6–9 years)
and NRS (10–18 years). This was done for every painful
puncture, two patients using a broviac catheter were notincluded here. While pain levels are very low before andafter the intervention, there is a rise in pain perception
peri-interventionally. Especially in group A (SOC) thisrise is visible: the average pain changes from 0.22 to 2.5 to
0.33. In group B (VR) the pain is significantly lower periinterventionally (p < 0.05): it changes from 0.08 to 1.58 to
0.53 (see Fig. 3). This shows patients seem to experiencesignificantly lower levels of pain using the VR goggles
during a painful puncture.

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Fig. 2 Prior experiences with the painful intervention measured with 5-point likert scale (n = 38)

Fig. 3 Pain outcomes measured with FPS-r/NRS (scale range: 0–10; n = 36)

Fig. 4 Anxiety outcomes measured with mYPAS-SF (scale range: 23–100, higher range stating higher levels of anxiety; n = 38)

Distress and anxiety outcomes

Subjective observations of patients and parents

Distress was documented using BAADS, whereas Anxiety was documented with help of mYPAS-SF. Both scales
were used when the patient was entering the intervention
room and just before/during the potentially painful intervention. For distress the sum of BAADS showed a significant reduction while using the VR-goggles in comparison
to SOC (average of 2.6 in the VR-group vs. 3.1 for SOC;
scale range 0–10; p < 0.01). Anxiety was measured separately for the two points in time, showing significantly
lower levels (average of 28.6 in the VR-group vs. 33.5 for
SOC; scale range 23–100) even before the actual usage ofthe goggles (p < 0.001). Peri-interventionally this reduction (average of 34.9 in the VR-group vs. 44.4 for SOC)
is even more apparent (p < 0.001; see Fig. 4). This shows
patients seem to experience significantly lower levels ofanxiety while using VR goggles during a painful puncture.

Relaxation and fun were measured using a 5-point likert
scale. Most patients stated they felt more relaxed with VR
accompanying the painful intervention. More than 90%
claimed they had a fun experience using the VR-goggles.
Nevertheless a few patients also stated they wouldn’t use
VR again, because they didn’t feel more relaxed than usually (see Fig. 5).The parents perspective shows,, equivalent to the patients point of view, that there is a highagreement with relaxation through and future usage of
VR. This was also measured using a 5-point likert scale.
Hints for the implementation of VR

For the successful implementation of VR as a distraction
method in an outpatient clinic setting, six main categories were identified. These include finance, responsibility,
expertise, time, teamwork and use of VR. As a result ofReitze et al. BMC Pediatrics(2024) 24:501

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Fig. 5 Observations on VR-usage from the patients perspective measured with 5-point likert scale (n = 38)

an interprofessional focus group discussion at the end of
the study period, the following 10 tips were formulated
by consensus of the group.1. Financial means for theacquisition and maintenance of the VR-equipment must
be ensured. 2. Applicability should be considered in the
choice of equipment (e.g. comfortable to wear for children, disinfection option). 3. When implementing VR
in the outpatient clinic, nurses and physicians must be
involved together. 4. The storage location and access tothe VR goggles have to be coordinated within the team.
5. Responsibilities must be in few people. 6. Medical students and volunteers are suitable as additional staff for
explaining VR to patients. 7. VR provider must be trained
to avoid overstraining in stressful situations and technicalproblems. 8. Sufficient time must be planned for explaining the goggles when they are used for the first time. 9.
Parents should be involved in the demonstration andexplanation (role model function). 10. Evaluations of theapplication should take place regularly in order to quickly
identify everyday problems.

Discussion
Peri-interventional use of VR as an approach to reduce pain
and anxiety

The present study investigated the peri-interventional
impact of VR as a distraction tool on the parameters of
pain, anxiety, and distress in a pediatric oncology outpatient clinic. The effect of distraction during potentiallypainful examinations in general and the influence of VR
in particular are well studied [15, 16]. While the qualityof previous studies on pediatrics is heterogeneous, there
is a lack of studies on its use in pediatric oncology outpatient clinics with corresponding investigation of its
applicability in this specific setting [6]. The present study
shows that the peri-interventional use of VR can decrease
pain perception and pain-related anxiety. This could
also be shown by Gerçeker et al. [17] in pediatric oncology patients for port needle-related anxiety and pain. A
limitation is the high rate of refusals to participate in the

study and the number of drop-outs or lost-to-follow-ups.
Comparable challenges were also reported by Gold et al.
[4]. Reasons could be skepticism about the glasses, shorttime intervals in the outpatient clinic, or insufficient
information. Fear of adverse side effects or concern aboutloss of control could also contribute. This contrasts withthe large proportion of subjectively positive experiences.
Only 5% discontinued the glasses prematurely, whereas
95% expressed fun uing VR peri-interventionally. In
the future, patients should be identified in advance who
might particularly benefit from VR use or in whom aneffect might produce undesirable effects. Questionnaires
or screening instruments have not yet been developed
for this purpose. The studies on distress and anxiety
showed a significant reduction by VR. The clinical relevance is expressed in an increasing cooperativeness of thepatients, which is recorded by the scores. This allows aneasier procedure not only for patients but also for theirparents and the staff involved. In this setting, the individual’s previous experiences and needs with regard to
distraction methods, anxiety and stress should be given
greater consideration in the patient’s medical history inorder to make more room for the patient’s needs.
Requirements in the implementation of VR in an
outpatient clinic

A novel feature is the description of specific implementation instructions by an interprofessional focus group.
Tennant et al. also focused on health care professionals.
This research method can also be used to uncover local
resistance and address information needs in the implementation process. Tennant et al. also focused on VR and
its applicability [18]. There is disagreement as to which
professional group should best bring VR to children. Thisis consistent with our findings that new personnel andtime resources need to be made available. The additionaltime required of existing staff or the need to employ
additional, well-trained staff proved challenging. A “lowthreshold” introduction of VR glasses as a distraction

Reitze et al. BMC Pediatrics(2024) 24:501

method does not appear to make sense due to content
and technical challenges. Therefore personnel and time
resources must be made available to ensure effective support in terms of individually taking care of patients, theirfamilies and also the technical requirements.
Limitations and future research

One weakness of the study is the number of drop-outs
and refusals to participate in the study. Reasons for thisincluded uncertainty about the use of VR for punctures
or a lack of interest in participating in the study. Amongthe observations that were not completed, the main reasons were patients’ health and difficulties in scheduling.
This seems to be a realistic reflection of complex clinicalsituations. A higher number of researchers would havebeen advantageous here in terms of inclusion, but challenging for the standardization of observations. Gold et
al. also mention comparable numbers of participants andrefusals, which supports these speculations [4].
A limitation, in addition to the presented rate of fullycompleted cross-over observations, is the influence of theinvestigators due to the required observations for scoresand scales. Objective measurements of the examinedparameters are difficult in the clinical routine and in theoutpatient clinic. Extensive training of the investigators
should reduce a corresponding bias. The limited responseof detailed questionnaires to describe stress management in the collective reduces the validity. A reduced
number of survey items could increase the response
rate but limits the breadth of information generated. In
addition, it would be conceivable to examine patients
without any previous experience. Patients with no previous experience of the procedure were not included in
the study group, meaning that the effect on completelynaïve patients cannot be assessed with certainty. Previous experience was recorded using a Likert scale fromthe important patient perspective (see Fig. 2), but without correlating it with the exact number of previous
punctures. Future investigations of receptivity to VR asa distraction method should target personal factors andcapture experiences as a baseline for choosing the best
support.
Observation time points peri-interventionally werelimited to entering the room, the moment immediately
before the intervention, and a few minutes after theintervention. Video documentation with subsequent
close-meshed analysis could be used - but in a very
resource-intensive way - for a more detailed description.
Bias due to retrospective recording of patient, parent,
and staff experiences are conceivable.
Studies suggest the potential to reduce medications.
Nevertheless, anti-anxiety and analgesic medications
should not be withheld from any patient immediately
for bone marrow puncture. The primary purpose of VR

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goggles is to increase the quality of treatment. Due to thelimited number of cases, the subgroup analyses could
not provide any meaningful, clinically relevant results
regarding differences in the effect of VR in subgroups. All
options for reducing pain, anxiety and stress should beconsidered for the individual patient.
Although technological capabilities expand the rangeof diversionary methods, the primary focus remains on
trained, attentive, and flexible staff who must anticipate
the best way to provide peri-interventional support asconditions change and patients vary individually.
Future studies need to shed light on the influence of
VR as a complementary aspect of successful distraction
methods peri-interventionally and provide impetus to
identify particularly susceptible patients. Nevertheless,even the consideration of VR as a method of distraction
for pain and stress reduction can lead to a meaningful
discussion of the topic in terms of improving patient care.
Acknowledgements
We would like to thank the company SyncVR for the free use of the productfor independent research activities.
Author contributions
All authors contributed to the study conception and design. Material
preparation, data collection and analysis were performed by A.R., U.M. and
F.K. The first draft of the manuscript was written by A.R. and U.M. All authors
commented on previous versions of the manuscript. All authors read andapproved the final manuscript.
Funding
No funds were received for the realisation of this study.
Open Access funding enabled and organized by Projekt DEAL.
Data availability
The datasets used and analysed during the current study are available fromthe corresponding author on request.

Declarations
Ethics approval and consent to participate
This study was performed in accordance with the Declaration of Helsinki.
Approval was granted by the Ethics Committee of Hannover Medical School(18.05.2021/N. 9705_BO_S_2021). Written informed consent was obtained
from the patients and parents and staff.
Consent for publication
Not applicable.
Competing interests
The authors have no relevant financial or non-financial interests to disclose.
Author details
1
Hannover Medical School, Pediatric Oncology and Hematology, Hanover,Germany2Helmholtz Centre for Infection Research, Braunschweig, Germany
3
Ostfalia University, Wolfenbüttel, Germany
4
Hannover Medical School, Anesthesiology and Intensive Care Medicine,
Hanover, Germany
5
University Hospital Bonn, Center for Rare Diseases, Bonn, Germany
Received: 2 March 2024 / Accepted: 16 July 2024

Reitze et al. BMC Pediatrics(2024) 24:501

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