Behaviors and Mental Disorders

All Conditions

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Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Anxiety Disorders

Hypertension

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Vascular Diseases

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Neurofibromatosis

Neurofibromatosis Type 1

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.

Measurement of Blood Pressure using Home blood pressure monitor

Group 1. Standard Home Blood Pressure Measurement

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

Gabriel Dabscheck, MBBS FRACP

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.

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.

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

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.

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.

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.

Daily measurement of systolic/diastolic (mmHg) home blood pressure(BP) reading (once only) using an automatic home oscillometer BP monitor measurement.

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

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

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.

Murdoch Childrens Research Institute

Digestive System Diseases

Nutritional and Metabolic Diseases

Adenoma

Colonic Polyps

Polyps

Colorectal Neoplasms

Colorectal Neoplasms, Hereditary Nonpolyposis

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasms, Glandular and Epithelial

Intestinal Polyps

Pathological Conditions, Anatomical

DNA Repair-Deficiency Disorders

Metabolic Diseases

Quality of Life

Herbal and Botanical

All Drugs and Chemicals

Cola

Within 60 days of their already scheduled screening colonoscopy, participants will provide a stool sample to be tested by a Cologuard screening test kit. Participants will also complete surveys prior to their colonoscopy as well as post colonoscopy.

Cologuard is a stool-DNA screening test for detecting colon cancer

Cologuard test

Rajiv Panikkar, MD

This study is aiming to enroll 90 patients with genetically confirmed Lynch Syndrome (LS) from Geisinger's High Risk Colorectal Cancer Clinic (HRC). Upon enrollment in the study, a Cologuard test will be ordered and the results will be blinded until data analysis. Patients enrolled in the study will also undergo a colonoscopy as part of their routine HRC visit.

The primary aim is to perform a pilot study to gain information toward the implementation of a larger prospective study that will compare the performance of Cologuard with the gold-standard colonoscopy in identifying advanced adenomas and colorectal cancers in LS. Data regarding rate of consent, and adherence to the protocol will be recorded. Since patients with known genetic predisposition to cancers tend to view screening tests more positively than the general population, a second aim of the study is to evaluate patient satisfaction with bowel preparation, colonoscopies, and Cologuard testing. Up to 90 individuals with genetically confirmed LS will be recruited via Geisinger's HRC to complete a goal of 90 Cologuard studies. Upon enrollment, Cologuard will be ordered by the study team at no cost to the subject and will be completed according to the standard instructions for use. Results will be securely obtained and blinded until the time of data analysis. Subjects will undergo colonoscopy as part of their routine HRC visit. Results from the colonoscopy (and biopsy as indicated) will be retrieved from the Electronic Health Record (EHR) and documented in a research-associated spreadsheet. If repeat colonoscopy is clinically indicated, repeat Cologuard may be completed if the subject meets inclusion criteria.

Evaluating the Cologuard Test for Use in Lynch Syndrome

To evaluate the feasibility of Cologuard in a high-risk population, a summary report of the enrollment/consent rate and adherence to the protocol will be provided. Additional analyses comparing the results (given as positive/negative) Cologuard with the gold standard of colonoscopy will be performed using diagnostic tests including sensitivity, specificity, positive predictive value and negative predictive value.

To evaluate patient satisfaction of Cologuard the responses to the Geisinger Cologuard Satisfaction Questionnaire will be summarized. The questionnaire is composed of 15 questions. There are two primary questions are "How satisfied are you with the process of using Cologuard which uses a 5 point Likert Scale (Very satisfied to Very Dissatisfied) and "would you recommend Cologuard using a 10 point Likert scale (Not at all likely to Extremely Likely). Other categorical questions are either yes no response or an ordinal response with 4 categories. There are 6 questions that are open text responses to give more details as to why the selected their categorical response. The information gathered in the open responses is qualitative and will be used to provide guidance of approach and protocol for a future study.

Assess the results of the 12-Item Short Form Health Survey (SF-12) collected at the initial subject contact. Responses will be summarized.

Assess the results of the Patient Health Questionnaire - 9 (PHQ-9) collected at the time of their High-Risk Clinic Visit. Responses will be summarized.

Assess the results of the General Anxiety Disorder - 7 item scale (GAD-7) collected at the initial subject contact and that collected at the completion of their participation. Responses will be summarized

Assess the results of the Mayo Florida Bowel Prep Tolerability Questionnaire (MFBT-9) collected at the completion of the subject's participation. Responses will be summarized.

Geisinger Clinic

Sponsor - Investigator

Pain

Pain, Procedural

Mental Disorders

Psychotic Disorders

Neurologic Manifestations

Virtual Reality was used before and during punctures. For every observation patients underwent either port puncture or peripheral venous puncture. One examination was carried out according to the Standard-of-Care. The other one was carried out with the additional use of VR. Participants watched a passive distraction video.

Virtual Reality

Urs Mücke, Dr.

Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain reduction by virtual reality (VR) during port and vein punctures is well studied. This study investigates peri-interventional reduction of pain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric oncology outpatient clinic.

In a randomized, controlled cross-over design, patients aged 6-18 years experience potentially painful interventions accompanied by VR. All patients included in the study underwent port puncture or peripheral venous puncture in two observations : SOC (A) and VR (B) in a randomized order. Observational instruments include Numeral Rating Scale (NRS), Faces Pain Scale revised (FPS-r), Behavioral Approach Avoidance Distress Scale (BAADS), modified Yale Preoperative Anxiety Scale (mYPAS-SF). In addition, parents and staff are interviewed. Specific conditions for VR in an outpatient clinic setting are being discussed.

Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic

Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic: a Randomized Controlled Trial

Parents and patients were given different statements

Involved staff were asked about experience/feedback

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Hypnosis and Home Blood Pressure Monitoring in Children With Neurofibromatosis Type 1	NCT05196854	Hypertension Neurofibromatos... Blood Pressure	Group 1. Standa... Group 2. Hypnos...	5 Years - 18 Years	Murdoch Childrens Research Institute
Evaluating the Cologuard Test for Use in Lynch Syndrome	NCT04778566	Lynch Syndrome Colorectal Canc... Colonic Adenoma Colonic Polyp	Cologuard test	18 Years - 89 Years	Geisinger Clinic
Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic	NCT06235723	Pediatric Cance... Procedural Anxi... Procedural Pain	Virtual Reality	6 Years - 18 Years	Hannover Medical School

Spots Global Cancer Trial Database for procedural anxiety