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

Sponsor
Claude Bernard University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05235035
Collaborator
(none)
30
1
10.6
2.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Night shift work

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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official 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
Actual Study Start Date :
Jan 12, 2022
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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

Behavioral: Night shift work
Subjects are exposed to irregular sleep and sleep misalignment due to hospital night shifts.

Outcome Measures

Primary Outcome Measures

  1. Comparison of pain recognition accuracy during day or night [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 [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 Outcome Measures

  1. Prior Shift - Total Sleep Time in h compared between shift types [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 [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 [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 [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 [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 [1 day]

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

  7. Shift Work Expertise in years [1 day]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Claude Bernard University Lyon France

Sponsors and Collaborators

  • Claude Bernard University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Lilot Marc, Principal Investigator, Claude Bernard University
ClinicalTrials.gov Identifier:
NCT05235035
Other Study ID Numbers:
  • PAIN-EASE
First Posted:
Feb 10, 2022
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lilot Marc, Principal Investigator, Claude Bernard University

Study Results

No Results Posted as of Feb 10, 2022