RecruitingNot ApplicableNCT05738278

Heart Rate Informed Changes in Care for Non-Communicating Patients

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


Sponsor

University of Oslo

Enrollment

38 participants

Start Date

Feb 27, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 5 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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 Criteria1

  • \- Having any autoimmune disorder or any type of cancer with ongoing chemotherapy.

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Interventions

BEHAVIORALHR-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.

BEHAVIORALDelayed 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

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NCT05738278


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