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Completed

NCT Number: NCT05235035

PAIN Empathy Assessment in Sleep Deprived Emergency & Acute Care Clinicians

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.

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Key information

Conditions

Empathy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Claude Bernard University

Lyon, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Night shift work

Behavioral

Subjects are exposed to irregular sleep and sleep misalignment due to hospital night shifts.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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

  6. Health Care Professional Work Expertise in years

    Time frame: 1 day

    Self-reported years of work experience as a health care professional

  7. Shift Work Expertise in years

    Time frame: 1 day

    Self-reported years of work experience in a shift work system

Sponsors and collaborators

Lead sponsor

Claude Bernard University

Other

Registry information

Official study title

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

Acronym: PAIN-EASE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2022
Registry last updated
Nov 8, 2022

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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