Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1
Primary Purpose
Hypertension, Neurofibromatosis 1, Blood Pressure
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Group 1. Standard Home Blood Pressure Measurement
Group 2. Hypnosis script prior to home blood pressure measurement
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension focused on measuring Procedural Anxiety, Clinical Hypnosis, Neurofibromatosis, Hypertension, Blood pressure monitoring
Eligibility Criteria
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.
Sites / Locations
- Murdoch Children's Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Group 1: Standard Blood Pressure measurement at home
Group 2. Hypnosis script prior to Home Blood Pressure measurement
Arm Description
Standard home blood pressure measurement at home
Participant listens to a pre-recorded hypnosis script (approx 5 mins long) prior to standard home blood pressure measurement.
Outcomes
Primary Outcome Measures
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. 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 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 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 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.
Secondary Outcome Measures
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
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
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
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
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
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.
Full Information
NCT ID
NCT05196854
First Posted
December 21, 2021
Last Updated
April 26, 2023
Sponsor
Murdoch Childrens Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05196854
Brief Title
Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1
Official Title
Feasibility and Comparison Study of Home Blood Pressure Monitoring and Clinical Hypnosis in Children With Neurofibromatosis Type 1
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
April 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Murdoch Childrens Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Neurofibromatosis 1, Blood Pressure
Keywords
Procedural Anxiety, Clinical Hypnosis, Neurofibromatosis, Hypertension, Blood pressure monitoring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Control Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Standard Blood Pressure measurement at home
Arm Type
Other
Arm Description
Standard home blood pressure measurement at home
Arm Title
Group 2. Hypnosis script prior to Home Blood Pressure measurement
Arm Type
Experimental
Arm Description
Participant listens to a pre-recorded hypnosis script (approx 5 mins long) prior to standard home blood pressure measurement.
Intervention Type
Other
Intervention Name(s)
Group 1. Standard Home Blood Pressure Measurement
Intervention Description
Measurement of Blood Pressure using Home blood pressure monitor
Intervention Type
Other
Intervention Name(s)
Group 2. Hypnosis script prior to home blood pressure measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Day 1. Clinic-based manual sphygmomanometer blood pressure measurement
Description
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.
Time Frame
Day 1. Day of recruitment at the clinic appointment
Title
Day 1. Clinic-based automatic oscillometer blood pressure measurement
Description
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.
Time Frame
Day 1. Day of recruitment at the clinic appointment
Title
Day 2 Home automatic oscillometer blood pressure measurement
Description
Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.
Time Frame
Day 2 at home
Title
Day 3 Home automatic oscillometer blood pressure measurement
Description
Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.
Time Frame
Day 3 at home
Title
Day 4 Home automatic oscillometer blood pressure measurement
Description
Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.
Time Frame
Day 4 at home
Secondary Outcome Measure Information:
Title
Day 1. Clinic-based Children's Anxiety Meter Scale (CAM-S)
Description
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
Time Frame
Day1 in clinic
Title
Day 2,3 and 4 Daily Children's Anxiety Meter Scale (CAM-S) score
Description
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
Time Frame
Daily on Day 2, 3 and 4 at home.
Title
Day 2 Children's Anxiety Meter Scale (CAM-S) score
Description
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
Time Frame
Day 2 at home.
Title
Day 3 Daily Children's Anxiety Meter Scale (CAM-S) score
Description
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
Time Frame
Day 3 at home.
Title
Day 4 Children's Anxiety Meter Scale (CAM-S) score
Description
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
Time Frame
Day 4 at home.
Title
Day 4, Study specific survey of parents/caregivers perceptions
Description
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.
Time Frame
Day 4 only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Dabscheck, MBBS FRACP
Organizational Affiliation
Murdoch Children's Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Murdoch Children's Research Institute
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
6 months after publication of primary outcome
IPD Sharing Access Criteria
Data access agreement
Approval by Trial Steering Committee
Recognised Research Institute
Citations:
PubMed Identifier
28827377
Citation
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):
Results Reference
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Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1
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