Evidence

The clinical evidence behind Smileyscope

Smileyscope is supported by 20+ published studies, holds FDA / TGA / CE / MHRA clearance, and has been used across 400,000+ procedures

60%

Reduction in procedural pain

Chan 2019 [3]

40%

Reduction in anxiety

Chan 2019 [3]

92%

Avoided planned sedation  for paediatric MRI

Makhijani 2024 [5]

95%

Of clinicians say procedures are easier

Data on File RWEADS-2025v9

The evidence

A sedation-sparing adjunct for procedural sedation in children

Cravero JP, Roback MG

UpToDate cites Smileyscope as a nonpharmacologic, sedation-sparing adjunct for procedural sedation in children.

[1]

UpToDate (subscription)

The Infusion Therapy Standards of Practice

Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, et al.

The Infusion Therapy Standards of Practice uniquely name Smileyscope for vascular access pain management. The only VR device cited in the Standards.

[2]

Read the Standards of Practice guideline

Virtual reality for paediatric needle procedural pain

Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, et al.

Two randomised controlled trials, which are the largest RCTs in VR for procedural pain/anxiety to date. Examined children aged 4 to 11 years old, undergoing venous access procedures in the emergency department and outpatient phlebotomy. Found significant reductions in pain, anxiety, caregiver distress and use of restraints.

-60%

Pain (FPS-R)

-40%

Anxiety

-75%

Carer-rated distress

-48%

Use of restraint

[3]

VR for routine immunisations in needle-phobic children

Makhijani A, Jenkins N, Kaufman J, Hoq M, Priestley S, Elia S, et al.

Pilot study in needle-phobic children, including children with developmental disabilities, all of whom were scheduled for sedation. VR was able to avoid sedation for the majority of children, as well as improve patient/family satisfaction.

92%

Avoided planned sedation

100%

Of families would recommend

[4]

Using VR to assist coping in children undergoing clinical procedures

Samnakay S, Bell E, Evans D, Sommerfield D, Sommerfield A, Hauser N, et al.

Routine use across oncology, immunology, diabetes and general anaesthetic induction. High acceptability and improved coping reported across a range of busy clinical settings.

[5]

Acceptability and usability of Smileyscope during burn procedures

Storey K, Dimanopoulos TA, Plummer K, Kimble R, Xiang H, Griffin B.

Burn dressing changes, with perspectives from patients, carers and clinicians. Rated highly acceptable and usable by all three groups, with reduced pain, anxiety and improved epithelial tissue healing time.

[6]

PubMed Central PubMed

Enhancing paediatric MRI preparation with virtual reality tools

Johnson BP, Garrick A, Lawrence KA, Papafotiou J, Young T, Chen J, et al.

Qualitative study of current MRI preparation practices and the role of VR. Families and staff reported reduced stress and improved stillness, supporting sedation avoidance. Smileyscope's synopsis cites more than 90% general-anaesthetic avoidance in children originally scheduled for MRI under anaesthesia.

[7]

3D VR versus 2D video during induction of anaesthesia

Samnakay S, von Ungern-Sternberg BS, Evans D, Sommerfield AC, Hauser ND, Bell E, et al.

Randomised controlled trial comparing 3D VR with 2D video during the induction of anaesthesia in children. 3D VR reduced pre-induction anxiety more than 2D video.

[8]

A tailored COVID-19 vaccination pathway for children aged 5 to 11

Gordon SF, Lam J, Vasquez JT, Cercone R, Tenneti N, Hart J, et al.

Paediatric COVID-19 vaccination pathway in Victoria, Australia, ages 5 to 11. Well received as part of a child-friendly vaccination pathway increasing patient comfort and compliance, especially over a series of vaccinations.

[9]

PubMed Central PubMed

Reducing preoperative anxiety in paediatric patients with VR

Urban N.

Perioperative quality improvement project across a hospital-wide rollout.

87%

Of nurses and anaesthesia providers satisfied

[10]

Clinical efficacy of VR for acute procedural pain management

Chan E, Foster S, Sambell R, Leong P.

Systematic review and meta-analysis of 20 randomised controlled trials of VR during short clinical procedures. VR consistently lowered peak pain during short procedures. Immersive VR outperformed 2D and non-immersive VR.

[11]

PubMed Central PubMed

VR in paediatrics: effects on pain and anxiety

Tas FQ, van Eijk CAM, Staals LM, Legerstee JS, Dierckx B.

Updated systematic review and meta-analysis of VR for paediatric pain and anxiety. Confirms VR reduces paediatric pain and anxiety. The Smileyscope trials are rated among the strongest evidence in the field.

[12]

PubMed Central PubMed

VR during intrauterine device procedures

Collins J, Alexiuk N, Burgess J, Singh GJ, Forbes K, Jayadeva P, Day S.

London-based health service evaluation of VR during IUD and subdermal implant insertion, with a companion report on clinician experience.

93%

Would use it again

96%

Would recommend it

86%

Better than their previous IUD experience

[13, 14]

PubMed BASHH 2025 programme

VR for acute pain in outpatient hysteroscopy

Deo N, Khan KS, Mak J, Allotey J, Carreras FG, Fusari G, et al.

Randomised controlled trial during outpatient hysteroscopy. Lower reported pain during the procedure.

[15]

VR for analgesia during intrauterine device insertion

Higgins C, Zecena Morales C, Hocking J, Tyson K, Leung C, Larmour L, et al.

Randomised controlled trial during IUD insertion. Lower pain and a better overall procedure experience.

[16]

PubMed Central PubMed

VR headsets for work-related stress among midwives

Gantzopoulou A, Abdelnour-Nocera J, Belsi A, McDonald L, Macchia T, Cetinkaya G, et al.

Study of VR use for work-related stress among midwives. Reduced stress among staff.

[17]

Publisher (Springer)

VR for improved vasectomy experience

Codrington J, Qureshi F, Rahman F, Saltzman R, Deebel N, Cartaya S, et al.

Single-centre clinical trial during vasectomy, reported as a conference abstract. Reduced anxiety during the procedure.

[18]

VR for peri-procedural pain and anxiety at a spine clinic

Brown L, Chen ET, Binder DS.

Exploratory randomised controlled trial at an outpatient spine injection clinic. Reduced peri-procedural anxiety.

[19]

PubMed Central PubMed

VR for pain management in advanced heart failure

Groninger H, Stewart D, Fisher JM, Tefera E, Cowgill J, Mete M.

Randomised controlled study in inpatients with advanced heart failure. Improved pain scores and symptom burden.

[20]

VR to improve the quality of the hospital stay in neurosurgery

Vayssiere P, Constanthin PE, Baticam NS, Herbelin B, Degremont C, Blanke O, et al.

Ward use with neurosurgery inpatients during their hospital stay. Improved pain scores and patient satisfaction.

[21]

Publisher, open access

VR for tinnitus management

Deshpande AK, Bhatt I, Rojanaworarit C.

Randomised controlled trial in adults with tinnitus. Reduced perceived tinnitus intensity.

[22]

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References

[1]

Cravero JP, Roback MG. Procedural sedation in children: Approach. UpToDate. 2024.

UpToDate (subscription)

[2]

Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, et al. Infusion Therapy Standards of Practice, 8th Edition. Journal of Infusion Nursing. 2021;44(1S):S1–224.

Read the Standards of Practice guideline

[3]

Chan E, Hovenden M, Ramage E, Ling N, Pham JH, Rahim A, et al. Virtual Reality for Pediatric Needle Procedural Pain: Two Randomized Clinical Trials. The Journal of Pediatrics. 2019;209:160–167.

[4]

Makhijani A, Jenkins N, Kaufman J, Hoq M, Priestley S, Elia S, et al. Virtual reality for routine immunisations in needle phobic children with and without developmental disabilities: A pilot study. Vaccine. 2024;42(26):126481.

[5]

Samnakay S, Bell E, Evans D, Sommerfield D, Sommerfield A, Hauser N, et al. Assessing the Use and Acceptability of Virtual Reality to Assist Coping in Children Undergoing Clinical Procedures. Specialist Pediatric Nursing. 2025;30(1):e70002.

[6]

Storey K, Dimanopoulos TA, Plummer K, Kimble R, Xiang H, Griffin B. Acceptability and Usability of Smileyscope Virtual Reality for Paediatric Pain Management During Burn Procedures. Journal of Advanced Nursing. 2025;81(3):1568–1582.

PubMed Central PubMed

[7]

Johnson BP, Garrick A, Lawrence KA, Papafotiou J, Young T, Chen J, et al. Enhancing Pediatric Magnetic Resonance Imaging Preparation. Hospital Pediatrics. 2025;15(1):57–65.

[8]

Samnakay S, von Ungern-Sternberg BS, Evans D, Sommerfield AC, Hauser ND, Bell E, et al. 3-Dimensional Virtual Reality Versus 2-Dimensional Video for Distraction During the Induction of Anesthesia in Children. Anesthesia & Analgesia. 2025;141(3):629–638 [corrected].

[9]

Gordon SF, Lam J, Vasquez JT, Cercone R, Tenneti N, Hart J, et al. A tailored COVID-19 vaccination pathway for children 5–11 years in Victoria, Australia. Vaccine. 2023;41(22):3436–3445.

PubMed Central PubMed

[10]

Urban N. Reducing Preoperative Anxiety in Pediatric Patients with VR. Poster presented 2024; University of Miami / Nicklaus Children's Health System. No source located.

[11]

Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute procedural pain management: A systematic review and meta-analysis. PLOS ONE. 2018;13(7):e0200987.

PubMed Central PubMed

[12]

Tas FQ, van Eijk CAM, Staals LM, Legerstee JS, Dierckx B. Virtual reality in pediatrics, effects on pain and anxiety: A systematic review and meta-analysis update. Pediatric Anesthesia. 2022;32(12):1292–1304.

PubMed Central PubMed

[13, 14]

Collins J, Alexiuk N, Burgess J, Singh GJ, Forbes K, Jayadeva P, Day S. Feasibility and acceptability of virtual reality use during intrauterine device procedures: A London-based health service evaluation. BMJ Sexual & Reproductive Health. 2026;0:1–6.

PubMed BASHH 2025 programme

[14]

Ngu-Tazinya J, Collins J, Singh G, Cooney G, Forbes K, Alexiuk N, et al. Healthcare professional experiences of offering VR headsets to patients during IUD and subdermal implant procedures. BASHH Annual Conference 2025, Edinburgh, abstract MP006.

Conference programme

[15]

Deo N, Khan KS, Mak J, Allotey J, Carreras FG, Fusari G, et al. Virtual reality for acute pain in outpatient hysteroscopy: A randomised controlled trial. BJOG. 2021;128(1):87–95.

[16]

Higgins C, Zecena Morales C, Hocking J, Tyson K, Leung C, Larmour L, et al. Virtual Reality for Analgesia During Intrauterine Device Insertion: Randomized Controlled Trial. JMIR Serious Games. 2025;13:e72917.

PubMed Central PubMed

[17]

Gantzopoulou A, Abdelnour-Nocera J, Belsi A, McDonald L, Macchia T, Cetinkaya G, et al. Virtual Reality Headsets for Work-Related Stress Among Midwives. In: Human Work Interaction Design. Cham: Springer Nature Switzerland; 2026:93–109.

Publisher (Springer)

[18]

Codrington J, Qureshi F, Rahman F, Saltzman R, Deebel N, Cartaya S, et al. Virtual Reality for Improved Vasectomy Experience. The Journal of Sexual Medicine. 2024;21(Suppl 1):qdae001.250. Conference abstract.

[19]

Brown L, Chen ET, Binder DS. The use of virtual reality for peri-procedural pain and anxiety at an outpatient spine clinic injection visit. American Journal of Translational Research. 2020;12(9):5818–5826.

PubMed Central PubMed

[20]

Groninger H, Stewart D, Fisher JM, Tefera E, Cowgill J, Mete M. Virtual reality for pain management in advanced heart failure: A randomized controlled study. Palliative Medicine. 2021;35(10):2008–2016.

[21]

Vayssiere P, Constanthin PE, Baticam NS, Herbelin B, Degremont C, Blanke O, et al. Use of Virtual Reality to Improve the Quality of the Hospital Stay for Patients in Neurosurgery. Frontiers in Virtual Reality. 2021;2.

Publisher, open access

[22]

Deshpande AK, Bhatt I, Rojanaworarit C. Virtual reality for tinnitus management: A randomized controlled trial. International Journal of Audiology. 2021 (online first); print 2022;61(10):768–777.

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