Health TrialsbyHealthPanel

Heart Rate Informed Changes in Care for Non-Communicating Patients

ConditionsAutism Spectrum DisorderIntellectual DisabilityCommunication, Nonverbal
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-70
SponsorUniversity of Oslo

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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: 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.

  • 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: 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.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Situations identified by 2 standard deviation increase in HR

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.

Time frame
11 weeks

Secondary outcomes

1

HRV (ms)

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.

Time frame
6 weeks
2

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

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.

Time frame
6 weeks
3

Scores on quality of communication

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.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oslo

Lead sponsor

Source ClinicalTrials.gov
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