Using heart rate to improve care for non-verbal patients
Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial
This study is testing if using heart rate data can help caregivers provide better and more comfortable care for non-verbal patients, like those with autism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 5 Years to 70 Years |
| Sex | All |
| Sponsor | University of Oslo Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Oslo and 1 other locations) |
| Trial ID | NCT05738278 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the quality of care for non-verbal patients by utilizing heart rate (HR) data to identify and modify potentially painful care procedures. It will evaluate how HR can signal discomfort and assess the impact of HR-informed changes on pain biomarkers. Additionally, the study will explore how six weeks of communication through HR can improve interactions between patients and caregivers. The findings could lead to more compassionate and effective care strategies for individuals with autism and communication challenges.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 5 to 70 with autism spectrum disorder and communication difficulties who reside in care facilities or attend specialized schools.
Not a fit: Patients with autoimmune disorders or those undergoing chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve communication for non-verbal patients.
How similar studies have performed: While the use of heart rate as a communication tool is innovative, similar studies have shown promise in improving care for patients with communication challenges.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 5 and 70 years of age at the time of data collection * Autism spectrum disorder as evaluated by clinical psychologist * Communication difficulties * Living at a care home with round-the-clock staff for at least five days a week; or attending one-to-one staffed school/day-care at least five days a week. * Written informed consent is obtained from the subjects' legal representative. Exclusion Criteria: \- Having any autoimmune disorder or any type of cancer with ongoing chemotherapy.
Where this trial is running
Oslo and 1 other locations
- Oslo University Hospital — Oslo, Norway (Recruiting)
- University of Oslo — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Bjørnar Hassel — University of Oslo
- Study coordinator: Bjørnar Hassel, Professor
- Email: bjornar.hassel@medisin.uio.no
- Phone: 0047 98829754
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.