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

NCT05196854 | Completed

• 1 other identifier: 73244
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Neurofibromatosis 1; Blood Pressure

Keywords

Procedural Anxiety; Clinical Hypnosis; Neurofibromatosis; Hypertension; Blood pressure monitoring

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Day 1. Clinic-based Children's Anxiety Meter Scale (CAM-S)

  Day1 in clinic

• Day 2,3 and 4 Daily Children's Anxiety Meter Scale (CAM-S) score

  Daily on Day 2, 3 and 4 at home.

• Day 2 Children's Anxiety Meter Scale (CAM-S) score

  Day 2 at home.

• Day 3 Daily Children's Anxiety Meter Scale (CAM-S) score

  Day 3 at home.

• Day 4 Children's Anxiety Meter Scale (CAM-S) score

  Day 4 at home.

Study Arms (2)

Group 1: Standard Blood Pressure measurement at home

OTHER

Standard home blood pressure measurement at home

Other: Group 1. Standard Home Blood Pressure Measurement

Group 2. Hypnosis script prior to Home Blood Pressure measurement

EXPERIMENTAL

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

Interventions

Group 1. Standard Home Blood Pressure Measurement OTHER

Measurement of Blood Pressure using Home blood pressure monitor

Group 1: Standard Blood Pressure measurement at home

Group 2. Hypnosis script prior to home blood pressure measurement OTHER

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.

Group 2. Hypnosis script prior to Home Blood Pressure measurement

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (1)

Murdoch Children's Research Institute

Parkville, Victoria, 3050, Australia

Location

Related Publications (2)

• Mackay JR, Glenning JP, Grantham BM, Clark K, Mynard JP, Olweny CN, Quinlan C, Dabscheck G. Feasibility of home blood pressure screening in the paediatric outpatient clinic setting. Arch Dis Child. 2025 Jun 19;110(7):551-555. doi: 10.1136/archdischild-2024-327391.

  PMID: 39814532 BACKGROUND

• 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.

  PMID: 28827377 BACKGROUND

MeSH Terms

Conditions

Hypertension; Neurofibromatosis 1; Neurofibromatoses

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Gabriel Dabscheck, MBBS FRACP

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Control Trial

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 19, 2022
• Study Start: May 25, 2022
• Primary Completion: March 15, 2023
• Study Completion: April 24, 2023
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication of primary outcome
• Access Criteria: 1. Data access agreement 2. Approval by Trial Steering Committee 3. Recognised Research Institute

Locations

AU (1)