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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05196854




Registration number
NCT05196854
Ethics application status
Date submitted
21/12/2021
Date registered
19/01/2022
Date last updated
27/04/2023

Titles & IDs
Public title
Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1
Scientific title
Feasibility and Comparison Study of Home Blood Pressure Monitoring and Clinical Hypnosis in Children With Neurofibromatosis Type 1
Secondary ID [1] 0 0
73244
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Neurofibromatosis 1 0 0
Blood Pressure 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Skin 0 0 0 0
Dermatological conditions
Cancer 0 0 0 0
Other cancer types
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Group 1. Standard Home Blood Pressure Measurement
Other interventions - Group 2. Hypnosis script prior to home blood pressure measurement

Other: Group 1: Standard Blood Pressure measurement at home - Standard home blood pressure measurement at home

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 interventions: Group 1. Standard Home Blood Pressure Measurement
Measurement of Blood Pressure using Home blood pressure monitor

Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Day 1. Clinic-based manual sphygmomanometer blood pressure measurement
Timepoint [1] 0 0
Day 1. Day of recruitment at the clinic appointment
Primary outcome [2] 0 0
Day 1. Clinic-based automatic oscillometer blood pressure measurement
Timepoint [2] 0 0
Day 1. Day of recruitment at the clinic appointment
Primary outcome [3] 0 0
Day 2 Home automatic oscillometer blood pressure measurement
Timepoint [3] 0 0
Day 2 at home
Primary outcome [4] 0 0
Day 3 Home automatic oscillometer blood pressure measurement
Timepoint [4] 0 0
Day 3 at home
Primary outcome [5] 0 0
Day 4 Home automatic oscillometer blood pressure measurement
Timepoint [5] 0 0
Day 4 at home
Secondary outcome [1] 0 0
Day 1. Clinic-based Children's Anxiety Meter Scale (CAM-S)
Timepoint [1] 0 0
Day1 in clinic
Secondary outcome [2] 0 0
Day 2,3 and 4 Daily Children's Anxiety Meter Scale (CAM-S) score
Timepoint [2] 0 0
Daily on Day 2, 3 and 4 at home.
Secondary outcome [3] 0 0
Day 2 Children's Anxiety Meter Scale (CAM-S) score
Timepoint [3] 0 0
Day 2 at home.
Secondary outcome [4] 0 0
Day 3 Daily Children's Anxiety Meter Scale (CAM-S) score
Timepoint [4] 0 0
Day 3 at home.
Secondary outcome [5] 0 0
Day 4 Children's Anxiety Meter Scale (CAM-S) score
Timepoint [5] 0 0
Day 4 at home.
Secondary outcome [6] 0 0
Day 4, Study specific survey of parents/caregivers perceptions
Timepoint [6] 0 0
Day 4 only

Eligibility
Key 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,
Minimum age
5 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/04/2023
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Murdoch Children's Research Institute - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05196854
Trial related presentations / 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):
Public notes

Contacts
Principal investigator
Name 0 0
Gabriel Dabscheck, MBBS FRACP
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries