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RECRUITING
NCT05738278
NA

Heart Rate Informed Changes in Care for Non-Communicating Patients

Sponsor: University of Oslo

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

5 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

38

Start Date

2023-02-27

Completion Date

2025-12-30

Last Updated

2025-07-04

Healthy Volunteers

No

Interventions

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