Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1

Feasibility and Comparison Study of Home Blood Pressure Monitoring and Clinical Hypnosis in Children With Neurofibromatosis Type 1

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Blood Pressure; Neurofibromatosis 1
• Intervention / Treatment: Other: Group 1. Standard Home Blood Pressure Measurement; Other: Group 2. Hypnosis script prior to home blood pressure 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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriel Dabscheck, MBBS FRACP; Phone Number: +61 3 9345 4293; Email: gabriel.dabscheck@rch.org.au
• Study Contact Backup: Name: Jessie Mackay, BPhty; Phone Number: 0414711336; Email: jessie.mackay@mcri.edu.au

Study Locations

• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3050
      • Murdoch Children'S Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Is between the ages of 5 and 18 years old at enrolment.
• Has a diagnosis of neurofibromatosis type 1(NF1), confirmed by a physician, and usually attends the NF clinic at The Royal Children's Hospital, Melbourne, Australia (RCH). Including children with known kidney and cardiac disease.
• Primary residence and residential postal address in Victoria.
• The child can sit quietly for 10-15 minutes at home to complete a blood pressure assessment.
• Provide a signed and dated participant and/or parent guardian information and consent form and or has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
• For inclusive diverse study group, Parent/caregiver who require an interpreter can be enrolled in this study. Only inhouse interpreter services able to be included,

Exclusion Criteria:

• Has clinically significant cognitive impairment or attention disorder preventing ability to sit in a chair for 15 minutes
• Has confirmed hypertension on previous testing
• Parent/caregiver who require an interpreter and cannot upload BP and Heart rate (HR) values online independently will be excluded from the study.
• Parent/caregiver requiring an interpreter, but the interpreter not present within the face-to-face appointment eg, phone interpreter services.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1: Standard Blood Pressure measurement at home; Standard home blood pressure measurement at home	Other: Group 1. Standard Home Blood Pressure Measurement; Measurement of Blood Pressure using Home blood pressure monitor
Experimental: Group 2. Hypnosis script prior to Home Blood Pressure measurement; Participant listens to a pre-recorded hypnosis script (approx 5 mins long) prior to standard home blood pressure measurement.	Other: Group 2. Hypnosis script prior to home blood pressure measurement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Day 1. Clinic-based manual sphygmomanometer blood pressure measurement	Three measures of Systolic/diastolic reading (mmHg) using manual sphygmomanometer by trained professional. Following The American Academy Pediatrics guidelines for best practice for blood pressure (BP) measurement to ensure true BP reading.	Day 1. Day of recruitment at the clinic appointment
Day 1. Clinic-based automatic oscillometer blood pressure measurement	One reading of systolic/diastolic reading (mmHg) using automatic oscillometer BP monitor by trained professional - Following The American Academy Pediatrics guidelines for best practice for blood pressure (BP) measurement to ensure true BP reading.	Day 1. Day of recruitment at the clinic appointment
Day 2 Home automatic oscillometer blood pressure measurement	Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.	Day 2 at home
Day 3 Home automatic oscillometer blood pressure measurement	Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.	Day 3 at home
Day 4 Home automatic oscillometer blood pressure measurement	Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.	Day 4 at home

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Day 1. Clinic-based Children's Anxiety Meter Scale (CAM-S)	Measurement of participant's reported state of anxiety in clinic when completing BP measurement using Children's Anxiety Meter Scale (CAM-S). CAM-S is a state of anxiety patient reported measure. It is coded 0-10 across a vertical analogue scale. 0 = calm, not nervous or worried 10 = very very nervous and worried	Day1 in clinic
Day 2,3 and 4 Daily Children's Anxiety Meter Scale (CAM-S) score	Daily measure of the participants reported state of anxiety when completing BP measurement at home using Children's Anxiety Meter Scale (CAM-S). CAM-S is a state of anxiety patient reported measure. It is coded 0-10 across a vertical analogue scale. 0 = calm, not nervous or worried 10 = very very nervous and worried	Daily on Day 2, 3 and 4 at home.
Day 2 Children's Anxiety Meter Scale (CAM-S) score	Daily measure of the participants reported state of anxiety when completing BP measurement at home using Children's Anxiety Meter Scale (CAM-S). CAM-S is a state of anxiety patient reported measure. It is coded 0-10 across a vertical analogue scale. 0 = calm, not nervous or worried 10 = very very nervous and worried	Day 2 at home.
Day 3 Daily Children's Anxiety Meter Scale (CAM-S) score	Daily measure of the participants reported state of anxiety when completing BP measurement at home using Children's Anxiety Meter Scale (CAM-S). CAM-S is a state of anxiety patient reported measure. It is coded 0-10 across a vertical analogue scale. 0 = calm, not nervous or worried 10 = very very nervous and worried	Day 3 at home.
Day 4 Children's Anxiety Meter Scale (CAM-S) score	Daily measure of the participants reported state of anxiety when completing BP measurement at home using Children's Anxiety Meter Scale (CAM-S). CAM-S is a state of anxiety patient reported measure. It is coded 0-10 across a vertical analogue scale. 0 = calm, not nervous or worried 10 = very very nervous and worried	Day 4 at home.
Day 4, Study specific survey of parents/caregivers perceptions	Study specific survey. Likert scales used to assess parent/caregiver perception with ease of use of home BP monitor, timeliness to complete measures and interference with family life compared to attending hospital appointment, ease of receiving and returning equipment, and financial cost to attend hospital appointment. Data will be reported for each item individually, as the proportion of parents/caregivers who responded positively on the Likert scale, where higher scores indicate less favorable responses.	Day 4 only

Collaborators and Investigators

• Sponsor: Murdoch Childrens Research Institute
• Investigators: Principal Investigator: Gabriel Dabscheck, MBBS FRACP, Murdoch Children'S Research Institute

Publications and helpful links

General Publications

• Flynn JT, Kaelber DC, Baker-Smith CM, Blowey D, Carroll AE, Daniels SR, de Ferranti SD, Dionne JM, Falkner B, Flinn SK, Gidding SS, Goodwin C, Leu MG, Powers ME, Rea C, Samuels J, Simasek M, Thaker VV, Urbina EM; SUBCOMMITTEE ON SCREENING AND MANAGEMENT OF HIGH BLOOD PRESSURE IN CHILDREN. Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents. Pediatrics. 2017 Sep;140(3):e20171904. doi: 10.1542/peds.2017-1904. Epub 2017 Aug 21. Erratum In: Pediatrics. 2017 Nov 30;: Pediatrics. 2018 Sep;142(3):

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): April 24, 2023

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 16, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Neurofibromatosis; Procedural Anxiety; Clinical Hypnosis; Blood pressure monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Neoplasms, Nerve Tissue; Peripheral Nervous System Diseases; Nervous System Neoplasms; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Nerve Sheath Neoplasms; Neurocutaneous Syndromes; Peripheral Nervous System Neoplasms; Hypertension; Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
• Other Study ID Numbers: 73244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The de-identified data set collected for this study will be available six months after publication of the primary outcome.

The study protocol, analysis plan and consent forms will also be available. The data may obtained from the Murdoch children's Research institute by emailing gabriel.dabscheck@rch.org.au Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the trial steering committee must see and approve the analysis plane describing how the data will be analysed, there must be and agreement around appropriate acknowledgement and and additional costs involve must be covered. Should the trial steering committee be unavailable, this role is delegated to the Murdoch children's Research Institute. Data will only be shared with a recognised research institution which has approved the proposed analysis plan.

• IPD Sharing Time Frame: 6 months after publication of primary outcome
• IPD Sharing Access Criteria: Data access agreement; Approval by Trial Steering Committee; Recognised Research Institute
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No