HypertensionNCT05196854
Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1
A study testing Group 1. Standard Home Blood Pressure Measurement and Group 2. Hypnosis script prior to home blood pressure measurement in people with Hypertension and Neurofibromatosis 1, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Hypertension, Neurofibromatosis 1, Blood Pressure
- What is being tested?
- Group 1. Standard Home Blood Pressure Measurement and Group 2. Hypnosis script prior to home blood pressure measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteAustralia
- Study dates
- 25 May 2022to 24 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Murdoch Children's Research Institute
Parkville, Victoria, 3050
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Hypertension, Neurofibromatosis 1, Blood Pressure
- Being tested
- Group 1. Standard Home Blood Pressure Measurement, Group 2. Hypnosis script prior to home blood pressure measurement
- Keywords
- Procedural Anxiety, Clinical Hypnosis, Neurofibromatosis, Hypertension, Blood pressure monitoring
- Medical subject headings
- Hypertension, Neurofibromatosis 1, Neurofibromatoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1. Standard Home Blood Pressure MeasurementOther
Measurement of Blood Pressure using Home blood pressure monitor
Group 2. Hypnosis script prior to home blood pressure measurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standard Blood Pressure measurement at home | Other | Standard home blood pressure measurement at home Receives: 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. Receives: Other: Group 2. Hypnosis script prior to home blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 4 at home
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 4 only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start25 May 2022
- Primary completion15 Mar 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Control Trial
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Dabscheck, MBBS FRACP, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196854
- Sponsor's protocol ID
- 73244
- Status last verified
- Feb 2025
- First submitted
- 21 Dec 2021
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39814532Flynn 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.
PubMed 28827377
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Comparison Study of Home Blood Pressure Monitoring and Clinical Hypnosis in Children With Neurofibromatosis Type 1
- ClinicalTrials.gov ID
- NCT05196854
- Acronym / sponsor ID
- 73244
- Conditions
- Hypertension, Neurofibromatosis 1, Blood Pressure
- Keywords
- Procedural Anxiety, Clinical Hypnosis, Neurofibromatosis, Hypertension, Blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Control Trial
| Arm | Type | Receives |
|---|---|---|
| Group 1: Standard Blood Pressure measurement at home | Other | Other: Group 1. Standard Home Blood Pressure MeasurementStandard home blood pressure measurement at home |
| Group 2. Hypnosis script prior to Home Blood Pressure measurement | Experimental | Other: Group 2. Hypnosis script prior to home blood pressure measurementParticipant listens to a pre-recorded hypnosis script (approx 5 mins long) prior to standard home blood pressure measurement. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1. Standard Home Blood Pressure MeasurementMeasurement of Blood Pressure using Home blood pressure monitor | Other | Group 1: Standard Blood Pressure measurement at home |
| Group 2. Hypnosis script prior to home blood pressure measurementPre-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. | Other | Group 2. Hypnosis script prior to Home Blood Pressure measurement |
Primary outcome
Day 1. Clinic-based manual sphygmomanometer blood pressure measurement
Time frame: Day 1. Day of recruitment at the clinic appointment
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. Clinic-based automatic oscillometer blood pressure measurement
Time frame: Day 1. Day of recruitment at the clinic appointment
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 2 Home automatic oscillometer blood pressure measurement
Time frame: Day 2 at home
Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.
Day 3 Home automatic oscillometer blood pressure measurement
Time frame: Day 3 at home
Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.
Day 4 Home automatic oscillometer blood pressure measurement
Time frame: Day 4 at home
Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.
6 secondary outcomes
Day 1. Clinic-based Children's Anxiety Meter Scale (CAM-S)
Time frame: Day1 in clinic
Day 2,3 and 4 Daily Children's Anxiety Meter Scale (CAM-S) score
Time frame: Daily on Day 2, 3 and 4 at home.
Day 2 Children's Anxiety Meter Scale (CAM-S) score
Time frame: Day 2 at home.
Day 3 Daily Children's Anxiety Meter Scale (CAM-S) score
Time frame: Day 3 at home.
Day 4 Children's Anxiety Meter Scale (CAM-S) score
Time frame: Day 4 at home.
Day 4, Study specific survey of parents/caregivers perceptions
Time frame: Day 4 only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Background: PubMed 39814532Mackay 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.
- Background: PubMed 28827377Flynn 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Dabscheck, MBBS FRACP principal investigator
Murdoch Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1. Standard Home Blood Pressure Measurement and Group 2. Hypnosis script prior to home blood pressure measurement in people with Hypertension and Neurofibromatosis 1, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 1. Clinic-based manual sphygmomanometer blood pressure measurement (time frame: Day 1. Day of recruitment at the clinic appointment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05196854, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.