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RECRUITINGINTERVENTIONAL

Heart Rate Informed Changes in Care for Non-Communicating Patients

Heart Rate Informed Changes in Care for Non-Communicating Patients: A Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The overarching aim is to generate knowledge to reduce incidence of pain in non-verbal patients' everyday life. The trial will 1) evaluate how HR can be used to identify potentially painful care procedures that should be re-evaluated in terms of the approach taken; 2) test the effect of heart rate (HR)-informed changes in potentially painful care procedures on biomarkers of pain, and 3) assess how six weeks of communication through HR affects the quality of communication between patient and caregiver.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form is obtained from the subjects' legal representative. Who Should NOT Join This Trial: \- Having any autoimmune disorder or any type of cancer with ongoing chemotherapy. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BEHAVIORAL

HR-informed change in routine

The intervention is given for a situation occuring at least ten times and accompanied by an increase in HR at least 80% of the time, during the two-week registration period. Change in care (intervention) is introduced from week 3. The intervention is in one of four forms: 1. changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch, 2. preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles, 3. change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or 4. revised personal hygiene procedure.

BEHAVIORAL

Delayed HR-informed specific change in routine

The intervention is given for a situation occuring at least twenty times and accompanied by an increase in HR at least 80% of the time, during the four-week registration period. Change in care (intervention) is introduced from week 5. The intervention is in one of four forms: 1. changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch, 2. preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles, 3. change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or 4. revised personal hygiene procedure.

Locations (2)

Oslo University Hospital
Oslo, Norway
University of Oslo
Oslo, Norway