Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1
Condition: Hypertension; Neurofibromatosis 1; Blood Pressure
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Hypertension
Study type: Interventional

Summary: 
      This study has two primary objectives. The first is to determine if it is feasible and
      reliable for children and families with a diagnosis of Neurofibromatosis Type 1 (NF1) to use
      of blood pressure (BP) monitor at home.

      The second is to determine if there is a difference between a child's measured home BP using
      standard instructions or using a clinical hypnosis script. This will be determined by a
      randomised control trial design.

      Standard and hypnosis Home BP will be compared to the gold standard measurement of BP
      measured by a trained health care professional in clinic.

      Children who participate will complete a clinic-based BP with a health care professional,
      then will be randomised into either the standard home BP measurement or using a hypnosis
      script prior to BP measurement.
    

Detailed description: 
      Neurofibromatosis Type 1 (NF1) is a rare autosomal dominate genetic disorder that affects an
      estimated that 1 in 2500 people or 10000 Australians. NF1 affects multiple systems throughout
      the body. The prevalence of hypertension(HTN) in children and adolescents in the general
      population is approximately 3.5%. Children and adolescents with a diagnosis of NF1 have an
      increased incidence of HTN, and has been documented as high as 6.1% to 12%. This is two times
      higher than the general population.

      Clinical adherence to the recommendation of recording annual blood pressure on patients has
      not been audited. The anecdotal experience of the authors is that most children do not have
      annual blood pressure (BP) measurements. With the increased uptake of telehealth following
      the COVID-19 pandemic, children and families may not be reviewed in person for significant
      periods of time as they prefer consultations over telehealth. As a result, children may miss
      having their annual blood pressure measured. As a young people with a diagnosis of NF1 have
      twice the risk of HTN, annual BP measurement is essential.

      The American Academy Paediatrics guideline outlines the best practice for BP measurement to
      ensure true BP reading: The child should be seated in a quiet room for 3-5 minutes before
      measurement, with back supported and feet uncrossed on the floor. The blood pressure should
      be measured on the right arm, using the correct sized cuff. This should be completed by a
      trained clinician. As part of this study, all participants will have a manual
      sphygmomanometer in clinic-based BP taken on day of recruitment.

      One of the primary objectives of this study is to determine if is feasible to use home blood
      pressure monitoring to screen children with NF1 for hypertension.

      Clinical Hypnosis is used as a non-pharmacological technique for reducing procedural anxiety,
      distress and discomfort with patients. Hypnosis scripts have been successfully used as
      non-pharmacological adjuncts to reduce pain and anxiety in adult patients undergoing
      interventional radiological procedures, demonstrating that the benefits of hypnosis
      techniques can be accessible to patients with little or no training or preparation.
      Furthermore, healthcare workers who are not experts in hypnosis can be trained to deliver
      scripts effectively.

      If a hypnosis script used while taking home blood pressure readings allows for a calm child
      and an equivalent clinic BP measure, hypnosis script and home BP monitoring could have
      greater application across the Royal Children's Hospital.

      Therefore the second aim of the study is to see if there is a difference in a child's BP
      measurements comparing a standard home BP measurement or utilising a calming hypnosis script
      prior to home BP measurement. This will be compared to the gold standard clinic-based BP
      measurement completed by a trained professional. The child's self-reported level of anxiety
      using the Children's Anxiety Meter Scale (CAM-S) will be measured after every BP measurement.
      In addition, family's perceptions of the process of home BP monitoring will also be
      collected.
    

Intervention name(s): Group 1. Standard Home Blood Pressure Measurement; Group 2. Hypnosis script prior to home blood pressure measurement
Intervention type(s): Other; Other
Intervention description(s): Measurement of Blood Pressure using Home blood pressure monitor; Pre-recorded clinical hypnosis script (approx 5 mins long) used prior to standard home blood pressure measurement. Clinical Hypnosis is used as a non-pharmacological technique for reducing procedural anxiety, distress and discomfort with patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised Control Trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Procedural Anxiety; Clinical Hypnosis; Neurofibromatosis; Hypertension; Blood pressure monitoring