Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Pressure | — | UNRESOLVED | — |
| Hypertension | — | UNRESOLVED | — |
| Neurofibromatosis 1 | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group 1. Standard Home Blood Pressure Measurement | Other | — | UNRESOLVED |
| Group 2. Hypnosis script prior to home blood pressure measurement | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Group 1: Standard Blood Pressure measurement at home
- description
- Standard home blood pressure measurement at home
- interventionNames
- Other: Group 1. Standard Home Blood Pressure Measurement
- type
- EXPERIMENTAL
- label
- Group 2. Hypnosis script prior to Home Blood Pressure measurement
- description
- Participant listens to a pre-recorded hypnosis script (approx 5 mins long) prior to standard home blood pressure measurement.
- interventionNames
- Other: Group 2. Hypnosis script prior to home blood pressure measurement
Primary outcomes (5)
- measure
- Day 1. Clinic-based manual sphygmomanometer blood pressure measurement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDMackay 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
- BACKGROUNDFlynn 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