Usefulness of Virtual Reality in the Management of Pain Associated With Venipuncture in Pediatrics: a Multi-center Randomized Clinical Trial
Phase: NA
Conditions: Virtual Reality, Pediatric ALL, Pain, Procedural
Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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RESEARCH PROTOCOL 
USEFULNESS OF VIRTUAL REALITY IN THE MANAGEMENT 
OF PAIN ASSOCIATED WITH VENIPUNCTURE IN PEDIATRICS: 
A MULTI-CENTER RANDOMIZED CLINICAL TRIAL (RealPED) 
 
Date: December 22, 2021 
 
PRINCIPAL INVESTIGATOR:  
Raquel Gil Piquer 
 
COLLABORATORS: 
 
Yolanda Mañes Jiménez, María España Marí, Purificación Solanes 
Donet, Nieves García Lledó, Natividad Pons Fernández, Susana 
Moltó Nogues, Sandra Marchirant Alarcón, Amparo López Martorell, 
Amparo Soler Gandía, Mª Carmen Sanz Penadés, Raquel Miravalls 
Torres 
 
 
INDEX 
1. Introduction  
2. Justification 
3. Hypothesis  
4. Objectives  
5. Patients and methods  
6. Bibliography 
 
 

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INTRODUCTION 
Pain in Paediatrics  
Throughout history, different definitions of pain have been formulated. The International 
Association for the Study of Pain (IASP) in 1979 defined pain as "an unpleasant sensory and 
emotional experience associated with actual or potential tissue damage, or described in terms of 
such damage"(1). In 1994, the end of the definition – "described in terms of such harm" – was 
excluded, because it was considered to exclude the paediatric population, the elderly or people 
with difficulties in expressing themselves. All definitions agree that pain is a personal and 
multifactorial experience with physiological, behavioural, emotional, developmental and 
sociocultural components, which result to a different perception of pain(2). 
The perception of childhood pain has been a source of controversy for years. Although it is 
currently accepted that infants and children may present pain, there is still a high rate of 
undertreatment of paediatric pain at the hospital level(3). The first step in treating pain is to make 
an adequate assessment of it(4). For this, we have three types of strategy: self-report or self-
evaluation, observation of behaviour and physiological assessment. 
Management of pain associated with procedures 
Certain procedures, such as venepuncture for a routine blood test, can cause pain, anxiety or fear in 
children. We have pharmacological and non-pharmacological analgesia techniques to treat pain and 
anxiety associated with procedures. Their implementation in hospitals and health centers has an 
impact on a better quality of care and greater satisfaction of children and their families.  
Some of the most widely used pharmacological methods are topical anaesthetics like EMLA. In 
addition, we have useful drugs in the treatment of anxiety associated with procedures, such as 
nitrous oxide or intranasal midazolam. (5). Non-pharmacological methods can complement 
pharmacological methods. They are generally effective and economical. They can be classified into 
(6):  
 
Support methods: promote psychosocial assistance to the child. Example: parental presence 
during procedures.  
 
Cognitive methods: try to influence the thoughts and imagination of children. Example: active 
or immersive distraction (playing, holding a conversation) and passive or non-immersive 
distraction (music therapy, watching TV).   
 
Behavioural methods: they are based on the child's own actions. Example: deep breathing. 
 
Physical methods: involve the sense of touch. Example: caresses, hugs.  
 
Virtual reality as a method of non-pharmacological analgesia  
Play, in a broad sense, is the main occupation of healthy children, so that through play their 
development is promoted and constitutes a means of communication and expression(7).  To date, 
studies have been conducted on various types of gambling. In a literature review in which the 
literature published between 2005 and 2015(8) was reviewed, it is stated that different games or 
toys have been shown to be effective in reducing pain and anxiety generated during venepuncture. 
Among them we find music tables, portable video games, virtual reality glasses and the 
kaleidoscope. 
 

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Virtual reality, like the other types of game, is another method of active distraction. However, it has 
its own characteristics that differentiate it from play therapy in general. Virtual reality is defined as 
"a computer-generated, interactive, three-dimensional environment into which the person is 
introduced"(9).  There are numerous studies conducted in paediatric age with virtual reality to 
reduce pain associated with procedures. Most of them have been performed in hospitalized 
patients or patients of the Emergency Department, who need intravenous insertion or blood test. 
In a randomized clinical trial conducted in our country with children aged 6 to 14 years(10), pain 
and anxiety associated with venepuncture and intravenous insertion were evaluated in a group that 
used virtual reality and in a control group with usual care (distraction with objects, questions of 
daily life).  
In this study, they obtained lower means of pain and anxiety in the virtual reality group, although 
without statistically significant differences, probably due to the small sample size (17 participants). 
Management of pain associated with procedures in Xàtiva-Ontinyent Health Department  
In Xàtiva-Ontinyent Health Department, a population of 194,799 inhabitants is served. Of these, 
26,165 are under the age of 15. Scheduled blood tests are performed at health centers of the 
department and at the two hospitals. 
Non-pharmacological analgesia methods such as the presence of parents, distraction of the patient 
talking about daily life and pharmacological analgesia methods such as the application of EMLA are 
usually used.  
1- JUSTIFICATION 
In Spain there is a high prevalence at the national level of paediatric pain, often related to 
procedures such as venepuncture. Currently, due to the rise of new technologies, there are 
numerous studies carried out with virtual reality as a method of analgesia, but they are very diverse 
in terms of the type of patient and procedure.   
With this project, we intend to verify the effectiveness of virtual reality in reducing pain and anxiety 
associated with scheduled blood collection in the paediatric population. 
2- HYPOTHESIS  
The use of virtual reality glasses decreases the pain associated with venepuncture in children. 
3- OBJECTIVES 
Main objective: to determine the effectiveness of the use of virtual reality in reducing pain and 
anxiety associated with scheduled blood tests.  
Secondary objectives: 
- To evaluate the satisfaction of parents or caregivers.  
- To evaluate the satisfaction of the professional in charge of venepuncture. 
4- PATIENTS AND METHODS  
5.1- STUDY DESIGN 
Multicenter randomized clinical trial carried out in 5 Health Centers and in the 2 Hospitals of the 
Xàtiva-Ontinyent Health Department, in which scheduled blood extractions are performed. The 
test will be carried out following the CONSORT guidelines(11). Patients are distributed in a 1:1 

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ratio to the intervention group (use of virtual reality during blood test) and to the control group 
(usual care). In the intervention group, OCULOS QUEST 2 Virtual Reality glasses will be used in 
which a video will be displayed from the beginning of the technique (preparation of material) to 
the end (compression). In the control group, venepuncture will be performed through usual care 
(distraction by nursing talking to the patient or through the use of topical anaesthetic in chronic 
patients undergoing multiple extractions). 
5.2- SELECTION OF THE SAMPLE 
The patients potentially eligible for the study will be those who come to perform a routine blood 
test to the centers participating in the study to perform a blood collection during the study 
recruitment period. 
The Questionpro calculator (https://www.questionpro.com/es/calculadora-de-muestra.html) 
was used to calculate the sample size. With a confidence level of 95%, a margin of error of +/- 5, 
and an available population of 70 children, the required sample is 60 patients. 
- Inclusion criteria:  
Children aged between 7 and 12 years, who agree, both they and their parents or tutors, to 
participate in the study by signing the informed consent.   
- Exclusion criteria: 
 
Children under 7 years old for not having completed the development of visual 
function(12).  
 
Children over 12 years old, since by expanding the age range, it would be a very 
heterogeneous sample. 
 
Not having signed the informed consent. 
 
Children with psychomotor and neurocognitive delay, due to the difficult assessment of 
anxiety. 
 
Children with visual or hearing disabilities, because they cannot adapt virtual reality 
glasses to their conditions. 
- Randomization:  
The sequence that will be carried out to carry out the study is: 
1- Inform and recruit the participant. 
2- Sign informed consent. 
3- Open the envelope with the randomization. 
4- Perform the technique (blood test with usual care or with virtual reality).  
- Pseudonymisation: 
After including patients in the study, they will be assigned a code that will be formed by the 
initials of the two surnames followed by the last 3 digits of the number of the health card 
number. 
5.3- OUTCOME MEASURES 
 - Primary outcome measures: 
- Pain associated with venepuncture (Visual Analogue Scale) (Figure 1) (13) 

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Figure 1. Visual Analogue Scale. 
 
 
- Anxiety associated with venepuncture: Groningen distress scale (Table 1) (14) 
Table 1. Groningen distress scale 
GRADE 
STATUS OF CHILD 
MUSCLE TENSION 
CRY 
1 
Calm and no cry 
No 
No 
2 
Tension without 
crying 
Clenches fists, pale 
knuckles, grinds 
teeth, closes eyes, 
muscle contraction, 
body stiffness 
No 
3 
Tension with some 
cry 
Like 2 
Intermittent 
4 
Tension and 
continuous cry 
Like 2 
Continuous 
5 
Aggression / 
screams / physical 
resistance 
Agitation, violent 
movements of the 
body and 
extremities, a lot of 
resistance to the 
procedure 
Continuous, 
screams 
- Secondary outcome measures: 
- 
Number of attempts for analytics (1 to 5). 
- 
Time required for analysis (minutes). 
- 
Difficulty level of the technique (easy, normal or difficult) 
- 
Parents satisfaction (1 = unsatisfied, 10 = very satisfied) 
- 
Nurse anxiety (1 = totally calm 10 = very anxious) 
- 
Pacient age at the moment of venipuncture (years) 
- 
Pacient sex     
- 
Venipuncture in the last 6 months (yes or not) 

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- 
Parental presence at the moment of venipuncture (yes or not) 
5.4- ETHICAL ASPECTS  
Prior to participation in the study, the parents or guardians of the patients will sign the informed 
consent. 
5.5- STATISTICAL ANALYSIS  
All the information obtained in the study will be tabulated in a database designed for this 
purpose in the SPSS program (Statistical Package for the Social Sciences) version 22, maintaining 
the anonymity of the patients. Descriptive analysis of the variables will be performed. The 
qualitative variables will be expressed with frequency distribution. Chi square will be applied to 
compare the qualitative variables and Mann Whitney U for ordinals. A significance level of p < 
0.05 is established. 
5- BIBLIOGRAPHY 
1. International Association for the Study of Pain (IASP) [Internet]. IASP press. 1994. Disponible en: 
https://www.iasp-pain.org/Education/Content.aspx?ItemNumber=1698  
2. Mínguez Navarro MC. Utilización de un sistema de videodistracción para disminuir la ansiedad y 
el dolor en niños durante la venopunción en un servicio de Urgencias Pediátricas [tesis doctoral]. 
Madrid: Universidad Autónoma de Madrid, Facultad de Medicina; 2013.  
3. Reinoso Barbero F. Prevalencia del dolor en los pacientes pediátricos hospitalizados en España. 
Rev 
Esp 
Anestesiol 
Reanim 
[Internet]. 
2013;60(8):421–3. 
Disponible 
en: 
http://dx.doi.org/10.1016/j.redar.2012.12.013  
4. Pancekauskaité G, Jankauskaité L. Paediatric Pain Medicine: Pain Differences, Recognition and 
Coping Acute Procedural Pain in Paediatric Emergency Room. Med (Kaunas). 2018;54(6):94. 
5. Fernández Santervás Y, Álvarez Arenas JM. Sedoanalgesia. En: Cruz Hernández M, García García 
JJ, Cruz Martínez O, Mintegi Raso S, Moreno Villares JM, editores. Manual de Pediatría. 4a Edición. 
Majadahonda: Ergon; 2020. p. 1571–7.  
6. OMS. Parte 2: Estrategias terapéuticas. En: Alivio del dolor y tratamiento paliativo en el cáncer 
infantil. Ginebra; 1999. p. 15–25.  
7. Martín del Cañizo M. Manejo del dolor a través de terapia de juego: revisión sistemática. Rev Ter 
Ocup Galicia. 2017;14(25):195–206.  
8. Castro Cuervo C, Sánchez Alonso P. Uso de métodos frente al dolor durante la venopunción en 
niños. NURE Investig. 2016;13(83):1–7.  
9. Buenache López A. La realidad virtual para el manejo del dolor en la edad pediátrica durante 
cuidados enfermeros en el ámbito hospitalario [trabajo final de grado]. Madrid: Universidad 
Autónoma de Madrid, Facultad de Medicina; 2020.  
10. Martin Valbuena S, Fernández Fernández JA, Fernández Fernández I. Eficacia de una 
intervención enfermera con realidad virtual en Urgencias Pediátricas: un ensayo clínico 
aleatorizado. Rev Enfermería Castilla y León. 2019;11(1):84–94.  
11. González de Dios J, Buñuel Álvarez J, González Rodríguez M. Listas guía de comprobación de 
ensayos clínicos: declaración CONSORT. Evid Pediatr. [Internet]. 2011;7(3):1–8. Disponible en: 
https://evidenciasenpediatria.es/files/41-11363-RUTA/72Fundamentos.pdf  

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12. Chen Y, Cheng S, Lee P, Lai C, Hou I, Chen C. Distraction using virtual reality for children during 
intravenous injections in an emergency department: A randomised trial. J Clin Nurs. 2020;(October 
2019):503–10.  
13. Guerrero Márquez G, Miguez Navarro MC, Sánchez García I, Plana Fernández M, Ramón Llácer 
M. Manejo del dolor en Urgencias Pediátricas. En: Protocolos diagnósticos y terapéuticos en 
Urgencias de Pediatría SEUP. 3rd ed. 2021.  
14. Sauceda-García JM, Valenzuela-Antelo JR, Valenzuela-Antelo JR, Maldonado-Durán JM. Estrés 
ante la venopunción en niños y adolescentes. Bol Med Hosp Infant Mex. 2006;63(162):1–8.