Virtual Reality for Children's Blood Sampling
Condition: Pain; Fear; Child, Only
Study type: Observational

Summary: 
      Virtual Reality (VR) is technology that simulates an immersive 3 dimensional environment for
      the user and is often used for immersive gaming experiences. The investigators will use VR in
      children who undergo painful procedures such as blood sampling and cannulation to investigate
      if VR reduces pain. The study will be carried out in 32 children admitted to the Royal
      Manchester Children in the UK and will assess feasbility of use VR, child and parent reported
      pain and therefore generate pilot data. This data will be used to design larger randomised
      control studies.
    

Detailed description: 
      Objectives

        1. Conduct initial acceptability/feasibility testing of VRH use with children undergoing
           venepuncture or cannulation in an acute, often unplanned inpatient setting in a
           children's hospital.

        2. Assess level of child and parent reported pain during procedure as well as change in
           heart rate.

        3. Generate pilot data to design software and develop methods, outcome measures and
           patient/family engagement for a large randomised control trial (RCT) in the same setting
           to establish efficacy of VRH in reduction of perceived pain.

      Outcome

        1. Perceived and reported pain/anxiety scores for children undergoing venepuncture or
           cannulation with VRH.

        2. Change in heart rate before, during and after painful procedure

        3. Clinicians' feedback on the use of VRH in inpatient painful procedures

      STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYIS Practitioners will be encouraged
      to contact the research team each time they are to perform a procedure between 0830H and
      1600H and, unless already with another child using VRH, the research team will come to speak
      to parents to consent to the study. If consent is obtained then the procedure will be
      performed using current standard care as well as use of a VRH. The Oculus Go is a cheap and
      quick to set up headset. Off the shelf software will be selected that will distract but not
      require the movement of both arms. Software such as The Blu, Ocean Rift and Pet lab will be
      selected, dependent upon the age of the patient.

      VRH will be brought to the room planned for procedure and set up for the child as part of the
      preparation for venepuncture/cannulation. Prior to application of VRH children will be asked
      to score their current pain score using the Wong Baker Faces Score (WBFS)1. This will be
      transcribed by the researcher. VRH use will be commenced at least 3 minutes prior to
      commencement of painful procedure. The procedure will then be performed by the practitioner
      and VRH supervised by parent(s). The researcher will not participate in the procedure beyond
      initial setup of the VRH to ensure real world feasibility is being tested for. Once the
      procedure is completed, the child will be allowed to continue using the VRH while clinicians
      and parents involved in the procedure fill in the feedback forms.

      Feedback forms for parents will focus on perceived pain score and short qualitative review
      regarding acceptability, whether they would consider repeat application at subsequent
      venepuncture procedures, if VRH was well tolerated and whether they felt it helped. Feedback
      from clinicians will focus on ease of use of VRH, if they felt it facilitated procedure or
      whether it was felt to prolong the procedure. Forms will be filled in by parents and
      clinicians themselves and then handed to the researcher.

      Children will then have the VRH removed and be asked to score their current pain again using
      the WBFS. Children's WBFS will be compared pre and post procedure. Assessment of
      acceptability/feasibility for children will be based on 3 questions - 1. Do they like it, 2.
      Was VRH wear comfortable and 3. Did they feel unwell whilst wearing VRH. Questionnaire
      answers will also be used to design future trials and bespoke VR software.

      Questionnaires will then be pseudonymised and transcribed on to a secure computer for
      analysis of data. Interpretation of data will be performed by the clinical research team. Any
      statistical analysis required will be performed using SPSS Statistics 25 on pseydonymised
      datasets. Paper questionnaires will be kept in a locked drawer, in a locked room, on a locked
      research unit where access is only via swipe card. Access to paper questionnaires and digital
      data will only be for the immediate clinical research team of Professor Banerjee and Dr
      Worth.

      1 Wong-Baker FACES Foundation (2018). Wong-Baker FACES® Pain Rating Scale. Retrieved
      [11/10/19}] with permission from http://www.WongBakerFACES.org

      STUDY SETTING The study will be performed on all paediatric inpatient wards at Royal
      Manchester Hospital. The research team will be based on the CCRF (Children's Clinical
      Research Facility) and will move to each ward as required to provide VRH for procedures.
      Participants will be accessed via identification by clinicians performing painful procedures.

      Royal Manchester Children's Hospital is the busiest children's hospital in the UK.
      Venepuncture and cannulation are routinely performed by a wide variety of staff including
      doctors, nurses and the IV access team. It is therefore an ideal location to conduct this
      study. Participants will undergo recruitment, discussion with the research team, consent and
      procedure all in the same location within Royal Manchester Children's Hospital. Participation
      in the study will not impact upon patient care and will not require patients or parents to
      move anywhere or do anything they would not already be doing as part of their inpatient stay.

      Inclusion criteria Any child of age 5-12 years who are an inpatient in Royal Manchester
      Children's Hospital over a 4 week study period will be considered for consent if they require
      venepuncture or cannulation for a medical reason as determined by their lead medical team.

      All individuals will be considered for inclusion in this study regardless of age, disability,
      gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion
      and belief, sex, and sexual orientation except where the study inclusion and exclusion
      criteria EXPLICITLY state otherwise.

      Exclusion criteria Children under the age of 5 years (may not fit the headset, may become
      upset) and over the age of 12 years (pubertal, more mature understanding and expectations)
      will be excluded.

      Children not needed venepuncture or cannulation will not be invited.

      Children who have worn VRH previously and recognise dizziness/sickness or other ill health
      symptoms will not be asked to consent.

      Parent/ guardians of children who are unsure about VRH will be excluded.

      Parents will not be excluded if their first language is not English. As far as possible a
      translator will be arranged to translate child/parent responses and give feedback.

      Size of sample For this feasibility study, the investigators aim to recruit 32 children
      during a 4 week period. Using the primary outcome acceptability of patient use, 32 children
      will enable us to identify our acceptability target of 75% of patients with 95% CI 56.6-88.5%
      (Clopper-Pearson exact). This number will also provide meaningful representation of a spread
      of gender, age groups, complexity of underlying illness, cultural and ethnic backgrounds to
      design future studies.

      Recruitment The study will be advertised a month and two weeks prior to the start via email
      targeting all doctors, IV practitioners and nurses within Royal Manchester Children's
      Hospital informing them of the availability of VRH headsets for distraction during
      venepuncture/cannulation. Posters detailing similar information will be distributed across
      all paediatric wards and in treatment rooms. Information will also be available on the trust
      intranet.

      Consent Informed consent will be taken from parents of patients recruited to the study. Both
      patients and parents will be given a written information sheet to read prior to consent. Once
      they have read this they will have the opportunity to ask any questions of the research team.
      If they agree to take part then parents will be asked to sign a consent form. Children will
      be given the option to sign an assent form if they wish but this will not be compulsory.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children age 5-12 years, both males and females, can have any or no underlying condition,
        admitted to the Royal Manchester Children's Hospital and undergoing venepuncture or
        cannulation for clinical need.