NCT07709364

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jul 2026Jun 2027

First Submitted

Initial submission to the registry

May 19, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 16, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

11 months

First QC Date

May 19, 2026

Last Update Submit

July 13, 2026

Conditions

Keywords

Heart Rate VariabilityHRVHealthcare practitionerPractitioner HRV

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    At completion of 20th clinical shift (each shift is 12 hours)

Secondary Outcomes (2)

  • Improvement in practitioner heart rate variability during clinical practice

    At completion of 20th clinical shift (each shift is 12 hours)

  • Participant-reported work effectiveness, job satisfaction, and stress levels

    At completion of 20th clinical shift (each shift is 12 hours)

Study Arms (1)

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).

Behavioral: Critical Participatory Action Intervention with HRV Feedback

Interventions

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.

Bedside nurses in Enhanced Recovery Unit

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nurse working in Enhanced Recovery Unit at Royal Papworth Hospital NHS Foundation Trust
  • Willingness to participate in the trial

You may not qualify if:

  • Staff with permanent pacemakers
  • Staff on medication that could affect HRV (e.g. b-blockers)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0AY, United Kingdom

Location

Study Officials

  • Robert Gatherer, MBBS

    Royal Papworth Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Project Manager

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Critical Participatory Action Research learning model, whereby practitioners can explore the nature and consequences of their practice utilising their HRV during two intervention periods.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2026

First Posted

July 16, 2026

Study Start

July 16, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations