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NCT Number: NCT05738278

Heart Rate Informed Changes in Care for Non-Communicating Patients

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.

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Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Behavior Child Development Disorders, Pervasive Communication Communication, Nonverbal Developmental Disabilities Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Nonverbal Communication Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Oslo, Norway

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HR-informed change in routine

Behavioral

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:

  • changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch,
  • preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles,
  • change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or
  • revised personal hygiene procedure.

Delayed HR-informed specific change in routine

Behavioral

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:

  • changes in physiotherapy, e.g., less rigorous movement in the identified painful stretch,
  • preparations for putting on corrective cast to stabilize joint and/or stretch spastic muscles,
  • change in procedures for transportation/lifting, e.g., new technique or adaptations made to equipment, or
  • revised personal hygiene procedure.

Primary outcomes

  1. Situations identified by 2 standard deviation increase in HR

    Time frame: 11 weeks

    The hypothesis is that a 2 standard deviation increase in HR can identify potentially painful care situations that require re-evaluation. Mean HR spike counts will be compared using a one-tailed paired sampled t-test to differentiate between suitable and unsuitable situations for care adjustments.

Secondary outcomes

  1. HRV (ms)

    Time frame: 6 weeks

    The hypothesis is that HR-informed changes in a patient-specific care procedures will potentially painful settings and thus reduce pain-related biomarkers of HRV as evaluated at the beginning and the end of the study period.

  2. Serum concentrations of MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17 (pg/ml)

    Time frame: 6 weeks

    The hypothesis is that HR-informed changes in a patient-specific care procedures will potentially painful settings and thus reduce pain-related blood biomarkers (MCP-1, IL-1RA, IL-8, TGFβ1, and IL-17) as evaluated at the beginning and the end of the study period.

  3. Scores on quality of communication

    Time frame: 6 weeks

    The hypothesis is that HR as an aid in communication will increase caregivers' understanding of the patient as measured by changes in perceived understanding of the patient from the beginning to the end of the study period.

Study contacts

Contact information is provided by the study sponsor or research team.

Bjørnar Hassel, Professor

CONTACT

[email protected]

0047 98829754

Emilie SM Kildal

CONTACT

[email protected]

45481949

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 22, 2023
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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