Critical Care NursingHRV-PRONCT07709364
Heart Rate Variability for Practitioner Stimulated Reflection and Decision-making Optimisation
A study testing Critical Participatory Action Intervention with HRV Feedback in people with Critical Care Nursing and Decision Making, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
At the heart of healthcare is the interaction between healthcare practitioners and patients. It is believed that optimisation of this interaction can improve patient relevant outcomes, safety and patient experience. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Critical Care Nursing, Decision Making, Mechanical Ventilation
- What is being tested?
- Critical Participatory Action Intervention with HRV Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jul 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nurse working in Enhanced Recovery Unit at Royal Papworth Hospital NHS Foundation Trust
- Willingness to participate in the trial
Who cannot join
- Staff with permanent pacemakers
- Staff on medication that could affect HRV (e.g. b-blockers)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0AY
Robert Gatherer, MBBS, 01223638000, robert.gatherer@nhs.net
Robert Gatherer, MBBS
About this study
At the heart of healthcare is the interaction between healthcare practitioners and patients. It is believed that optimisation of this interaction can improve patient relevant outcomes, safety and patient experience. Through utilisation of practitioner physiological data, heart rate variability (HRV), to help practitioners make better decisions and optimise practice, it is considered possible to improve decision making around patient care and improve outcomes and safety.
The modern intensive care unit (ICU) is a dynamic data rich environment requiring rapid and accurate decision making. Advances in ventilator technology, electronic patient monitoring and electronic health records (EHR) have provided exponential growth in data produced for patients and the need for complex decision making. However, data overload and alarm fatigue can result in poor understanding and a delayed response from the practitioner in addressing the patient's needs.
The aim of this study is to present and evaluate a psychophysiology training approach for practitioners derived from their cardiovascular response through the course of the working day, this will be measured using heart rate variability (HRV). Practitioner HRV has been shown to be linked to work related stress and is considered a biomarker of decision-making.
Read the detailed description
A Critical Participatory Action Research learning model is proposed, whereby practitioners can explore the nature and consequences of their practice utilising their HRV during two intervention periods. The aim is to improve practitioner performance and develop a more context aware approach to patient care.
Impact will be measured through:
- improvement in HRV of the practitioners
- measurement of response times to ventilator related events (decreased response times)
- improvement of time spent at bedside
- improvement in ventilation related outcomes for the patients.
- Reduction in bedside noise (reduced response time to alarms and reduction in inappropriate alarms)
- Conditions
- Critical Care Nursing, Decision Making, Mechanical Ventilation, Cognition, Heart Rate Variability (HRV)
- Being tested
- Critical Participatory Action Intervention with HRV Feedback
- Keywords
- Heart Rate Variability, HRV, Healthcare practitioner, Practitioner HRV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical Participatory Action Intervention with HRV FeedbackBehavioural
The intervention is based on a Critical Participatory Action Research learning model, using the participant's heart rate variability data collected during clinical shifts. Before the intervention, participants will complete repeated HRV monitoring and use a diary to record clinical events and reflections. The intervention includes facilitated workshops introducing reflective practice, cognitive bandwidth, and related educational concepts. Participants will receive individual coaching to review their HRV data and identify patterns and triggers in their clinical work, followed by group discussions to share experiences and develop strategies to adapt practice. A second workshop builds on this process with further reflection, additional HRV analysis, and collaborative strategy development. Between and after sessions, participants continue data collection and apply insights in practice, aiming to enhance clinical performance and develop a more context-aware approach to patient care.
| Study group | Role | What they receive |
|---|---|---|
| Bedside nurses in Enhanced Recovery Unit | Experimental | Baseline collection will consist of data from 20 bedside nurses over 10 shifts (12 hours +/- 3 hrs) each. 5 shifts post first intervention (1st workshop) and 5 shifts post second intervention (2nd workshop). Receives: Behavioral: Critical Participatory Action Intervention with HRV Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in response time to ventilator patient physiological alarms
Practitioner response time (in seconds) to ventilator-related physiological alarm events measured using ventilator event logs and bedside monitoring system records.
Measured: At completion of 20th clinical shift (each shift is 12 hours)
Adherence to bedside noise level targets
Duration of time (seconds) bedside noise levels remain outside predefined acceptable clinical thresholds, measured using bedside environmental noise monitoring during clinical shifts.
Measured: At completion of 20th clinical shift (each shift is 12 hours)
Secondary outcomes (2)
Improvement in practitioner heart rate variability during clinical practice
Can practitioners improve their HRV through the iterative stimulated reflection intervention.
Measured: At completion of 20th clinical shift (each shift is 12 hours)
Participant-reported work effectiveness, job satisfaction, and stress levels
Participant-reported perceptions of work effectiveness, job satisfaction, and stress levels measured using study questionnaires
Measured: At completion of 20th clinical shift (each shift is 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start14 Jul 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Care NursingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Critical Participatory Action Research learning model, whereby practitioners can explore the nature and consequences of their practice utilising their HRV during two intervention periods.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Robert Gatherer, MBBS, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709364
- Sponsor's protocol ID
- P03174
- Other IDs
- 25/HRA/2201
- Acronym
- HRV-PRO
- Status last verified
- Sep 2026
- First submitted
- 19 May 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability for Practitioner Stimulated Reflection and Decision-making Optimisation
- ClinicalTrials.gov ID
- NCT07709364
- Acronym / sponsor ID
- HRV-PRO / P03174
- Conditions
- Critical Care Nursing, Decision Making, Mechanical Ventilation, Cognition, Heart Rate Variability (HRV)
- Keywords
- Heart Rate Variability, HRV, Healthcare practitioner, Practitioner HRV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At the heart of healthcare is the interaction between healthcare practitioners and patients. It is believed that optimisation of this interaction can improve patient relevant outcomes, safety and patient experience. Through utilisation of practitioner physiological data, heart rate variability (HRV), to help practitioners make better decisions and optimise practice, it is considered possible to improve decision making around patient care and improve outcomes and safety.
The modern intensive care unit (ICU) is a dynamic data rich environment requiring rapid and accurate decision making. Advances in ventilator technology, electronic patient monitoring and electronic health records (EHR) have provided exponential growth in data produced for patients and the need for complex decision making. However, data overload and alarm fatigue can result in poor understanding and a delayed response from the practitioner in addressing the patient's needs.
The aim of this study is to present and evaluate a psychophysiology training approach for practitioners derived from their cardiovascular response through the course of the working day, this will be measured using heart rate variability (HRV). Practitioner HRV has been shown to be linked to work related stress and is considered a biomarker of decision-making.
Detailed description
A Critical Participatory Action Research learning model is proposed, whereby practitioners can explore the nature and consequences of their practice utilising their HRV during two intervention periods. The aim is to improve practitioner performance and develop a more context aware approach to patient care.
Impact will be measured through:
- improvement in HRV of the practitioners
- measurement of response times to ventilator related events (decreased response times)
- improvement of time spent at bedside
- improvement in ventilation related outcomes for the patients.
- Reduction in bedside noise (reduced response time to alarms and reduction in inappropriate alarms)
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Critical Participatory Action Research learning model, whereby practitioners can explore the nature and consequences of their practice utilising their HRV during two intervention periods.
| Arm | Type | Receives |
|---|---|---|
| Bedside nurses in Enhanced Recovery Unit | Experimental | Behavioral: Critical Participatory Action Intervention with HRV FeedbackBaseline collection will consist of data from 20 bedside nurses over 10 shifts (12 hours +/- 3 hrs) each. 5 shifts post first intervention (1st workshop) and 5 shifts post second intervention (2nd workshop). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nurse working in Enhanced Recovery Unit at Royal Papworth Hospital NHS Foundation Trust
- Willingness to participate in the trial
Key exclusion criteria (2 listed)
- Staff with permanent pacemakers
- Staff on medication that could affect HRV (e.g. b-blockers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical Participatory Action Intervention with HRV FeedbackThe intervention is based on a Critical Participatory Action Research learning model, using the participant's heart rate variability data collected during clinical shifts. Before the intervention, participants will complete repeated HRV monitoring and use a diary to record clinical events and reflections. The intervention includes facilitated workshops introducing reflective practice, cognitive bandwidth, and related educational concepts. Participants will receive individual coaching to review their HRV data and identify patterns and triggers in their clinical work, followed by group discussions to share experiences and develop strategies to adapt practice. A second workshop builds on this process with further reflection, additional HRV analysis, and collaborative strategy development. Between and after sessions, participants continue data collection and apply insights in practice, aiming to enhance clinical performance and develop a more context-aware approach to patient care. | Behavioural | Bedside nurses in Enhanced Recovery Unit |
Primary outcome
Reduction in response time to ventilator patient physiological alarms
Time frame: At completion of 20th clinical shift (each shift is 12 hours)
Practitioner response time (in seconds) to ventilator-related physiological alarm events measured using ventilator event logs and bedside monitoring system records.
Adherence to bedside noise level targets
Time frame: At completion of 20th clinical shift (each shift is 12 hours)
Duration of time (seconds) bedside noise levels remain outside predefined acceptable clinical thresholds, measured using bedside environmental noise monitoring during clinical shifts.
2 secondary outcomes
Improvement in practitioner heart rate variability during clinical practice
Time frame: At completion of 20th clinical shift (each shift is 12 hours)
Participant-reported work effectiveness, job satisfaction, and stress levels
Time frame: At completion of 20th clinical shift (each shift is 12 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Gatherer, MBBS principal investigator
Papworth Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Critical Participatory Action Intervention with HRV Feedback in people with Critical Care Nursing and Decision Making, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Project Manager (01223638000, jeong-min.chun@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in response time to ventilator patient physiological alarms (time frame: At completion of 20th clinical shift (each shift is 12 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.