PAIN Empathy Assessment in Sleep Deprived Emergency & Acute Care Clinicians (PAIN-EASE)

November 6, 2022 updated by: Lilot Marc, Claude Bernard University

The Effect of Sleep Misalignment on the Cognitive Empathetic Ability to Recognize Pain and to Evaluate the Pain Intensity in Others as Competence for Qualitative Care

Cognitive Empathy is relevant in clinical practice and will be assessed based on the accuracy of pain recognition and the pain intensity evaluation in a computerised task using facial expressions. Repeated measures across day and night shifts will provide the basis to understand the impact of shift work on those abilities in health care professionals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Assessment and management of the pain patients experience is one of the key skills needed in the field of anesthesiology. The consideration of non-verbal cues is essential, especially the recognition of facial expressions. The human ability to recognize emotions in others depends on the capacity for empathy of an individual, specifically cognitive empathy. In the clinical context empathy is understood as a set of skills and competences rather than a character trait. It may therefore vary due to various parameters. Currently there is no research available on the influence of shift work on the human ability to recognize pain in facial expressions. However, work schedules that do not fit the natural circadian rhythm are known to alter the processing of emotions. In particular the ability to judge the intensity of an emotion is influenced. Therefore, the hypothesis of the present study will be, that shift work impairs the pain assessment performance of an individual. To test this hypothesis, the effect of shift work on the performance in recognizing and assessing pain intensity of faces by health care professionals in the anesthesia department will be assessed. A repeated measures assessment will be used.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lyon, France
        • Claude Bernard University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Health Care Professionals:

Nurses, nursing assistants, child care nurses and volunteer doctors from the department of anesthesia and general resuscitation and thoracic cardiac pediatric

Description

Exclusion criteria:

  • refuse to participate
  • not working night shifts
  • no patient contact

Inclusion criteria:

  • working day and night shifts
  • health care professional with patient contact

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
health care professionals
Staff from the department of anesthesia and general resuscitation and thoracic cardiac pediatric with patient contact that regularly works in shifts including night shifts
Subjects are exposed to irregular sleep and sleep misalignment due to hospital night shifts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of pain recognition accuracy during day or night
Time Frame: 1 day, 1 night

Pain recognition ability measured as accuracy (percentage correct responses / total responses) when subliminally presented with faces of different emotions in a computerised task : 48 trials including 1/3 of painful stimuli and 2/3 of non-pain stimuli (other distractor emotions are happy, disgusted, sad, angry, surprised). Stimuli from Delaware Pain Database.

The change of accuracy during a shift (baseline measure at beginning of shift, post measure after shift) is compared between a day shift and a night shift

1 day, 1 night
Comparison in pain intensity on NPRS - numerical pain rating scale
Time Frame: 1 day, 1 night

Pain assessment ability is measured as intensity rating on the common NPRS 11-point Likert scale of 0 - 10 (0 representing no pain and 10 indicating maximum pain) when consciously presented with faces (48 trials) showing pain in different intensity levels in a computerized task including neutral distractors.

Stimuli from Delaware Pain Database. The change of intensity evaluation during a shift (baseline measure at beginning of shift, post measure after shift) is compared between a day shift and a night shift

1 day, 1 night

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prior Shift - Total Sleep Time in h compared between shift types
Time Frame: 1 day, 1 night
Before any shift participants are asked to give information on their sleeping behavior within the last 72 hours. The Total Sleep Time (TST = time asleep in bed excluding sleep latency and nocturnal awakenings) will be accumulated.
1 day, 1 night
Nap Time during Shift in h compared between shift types
Time Frame: 1 day, 1 night
After any shift participants are asked to give information on their sleeping behavior during the course of the shift. The Total Sleep Time (time asleep in bed excluding sleep latency and nocturnal awakenings) will be accumulated.
1 day, 1 night
Empathy - Jefferson Scale of Physician Empathy
Time Frame: 1 day
Empathy assessment by Jefferson Scale of Physician Empathy (JSPE; Zenasni et al., 2012). It is a brief self-report scale of 20 items with a 7-point Likert scale, ranging from 1= strongly disagree to 7=strongly agree (average Score between 1 and 7). Higher scores are indicating a higher level of empathy.
1 day
Prior Shift Recovery Quality on 5 point Likert Scale compared between shift types
Time Frame: 1 day, 1 night

Before any shift participants are asked to give information on their sleeping behavior within the last 72 hours which also includes the subjective evaluation of sleep quality, waking quality and form of the day on a five point likert scale (1 = very bad to 5 = very good). A composed score of these three evaluations will be created and compared according to shift type.

((average Sleep + average Wakening + average Form)/3)

1 day, 1 night
Comparison of speed in pain recognition task as cognitive performance during day or night shift
Time Frame: 1 day, 1 night
Reaction time during the subliminal pain recognition task as additional marker of cognitive performance. The change of reaction time during a shift (baseline measure at beginning of shift, post measure after shift) is compared between a day shift and a night shift
1 day, 1 night
Health Care Professional Work Expertise in years
Time Frame: 1 day
Self-reported years of work experience as a health care professional
1 day
Shift Work Expertise in years
Time Frame: 1 day
Self-reported years of work experience in a shift work system
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 12, 2022

Primary Completion (ACTUAL)

June 30, 2022

Study Completion (ACTUAL)

November 4, 2022

Study Registration Dates

First Submitted

January 7, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (ACTUAL)

February 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 6, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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