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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05196854
Ethics application status
Date submitted
21/12/2021
Date registered
19/01/2022

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
Trial website
Trial related presentations / publications
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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05196854