NCT05738278

Heart Rate Informed Changes in Care for Non-Communicating Patients

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: University of Oslo · Academic / Other
• Sex: All
• Age: 5 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Autism Spectrum Disorder
• Intellectual Disability
• Communication, Nonverbal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-27
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-02-22
• Last updated: 2025-07-04

Locations

2 sites across 1 country: Norway