Heart Rate Informed Changes in Care for Non-Communicating Patients

University of Oslo

Status: Enrolling

Conditions: Autism Spectrum Disorder; Intellectual Disability; Communication, Nonverbal

Treatments: Behavioral: HR-informed change in routine; Behavioral: Delayed HR-informed specific change in routine

Study type: Interventional

Funder types: Other

Identifiers

NCT05738278

#2016/1956

Details and patient eligibility

About

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.

Full description

Detailed protocol to be published as journal article with reference to Clinicaltrials.gov-registration. Preprint available: https://osf.io/gan42

Enrollment: 38 estimated patients

Sex: All

Ages: 5 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Intervention group

Experimental group

Description:

After 2 weeks mapping phase, patient-specific HR-informed intervention from week 3.

Treatment:

Behavioral: HR-informed change in routine

Control group

Active Comparator group

Description:

After 4 weeks mapping phase, patient-specific HR-informed intervention from week 5.

Treatment:

Behavioral: Delayed HR-informed specific change in routine