Hypertension Clinical Trial
Official title:
Feasibility and Comparison Study of Home Blood Pressure Monitoring and Clinical Hypnosis in Children With Neurofibromatosis Type 1
NCT number | NCT05196854 |
Other study ID # | 73244 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 25, 2022 |
Est. completion date | April 24, 2023 |
Verified date | April 2023 |
Source | Murdoch Childrens Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | April 24, 2023 |
Est. primary completion date | March 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Murdoch Children's Research Institute | Parkville | Victoria |
Lead Sponsor | Collaborator |
---|---|
Murdoch Childrens Research Institute |
Australia,
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): — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 |
Day1 in clinic | |
Secondary | 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 |
Daily on Day 2, 3 and 4 at home. | |
Secondary | 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 2 at home. | |
Secondary | 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 3 at home. | |
Secondary | 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 at home. | |
Secondary | 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. |
Day 4 only |
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