- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05235035
PAIN Empathy Assessment in Sleep Deprived Emergency & Acute Care Clinicians (PAIN-EASE)
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Lyon, France
- Claude Bernard University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
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Subjects are exposed to irregular sleep and sleep misalignment due to hospital night shifts.
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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
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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.
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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
|
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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
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|
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
Sponsor
Publications and helpful links
General Publications
- Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
- Gelinas C, Fillion L, Puntillo KA, Viens C, Fortier M. Validation of the critical-care pain observation tool in adult patients. Am J Crit Care. 2006 Jul;15(4):420-7.
- Czeisler CA, Pellegrini CA, Sade RM. Should sleep-deprived surgeons be prohibited from operating without patients' consent? Ann Thorac Surg. 2013 Feb;95(2):757-66. doi: 10.1016/j.athoracsur.2012.11.052. No abstract available.
- Geyer NM, Coetzee SK, Ellis SM, Uys LR. Relationship of nurses' intrapersonal characteristics with work performance and caring behaviors: A cross-sectional study. Nurs Health Sci. 2018 Sep;20(3):370-379. doi: 10.1111/nhs.12416. Epub 2018 Feb 28.
- Guadagni V, Burles F, Ferrara M, Iaria G. The effects of sleep deprivation on emotional empathy. J Sleep Res. 2014 Dec;23(6):657-663. doi: 10.1111/jsr.12192. Epub 2014 Aug 13.
- Hirsh AT, Jensen MP, Robinson ME. Evaluation of nurses' self-insight into their pain assessment and treatment decisions. J Pain. 2010 May;11(5):454-61. doi: 10.1016/j.jpain.2009.09.004. Epub 2009 Dec 16.
- Hojat, M. (2016). Empathy in health professions education and patient care.
- Killgore WDS, Balkin TJ, Yarnell AM, Capaldi VF 2nd. Sleep deprivation impairs recognition of specific emotions. Neurobiol Sleep Circadian Rhythms. 2017 Jan 21;3:10-16. doi: 10.1016/j.nbscr.2017.01.001. eCollection 2017 Jun.
- Kozlowski D, Hutchinson M, Hurley J, Rowley J, Sutherland J. The role of emotion in clinical decision making: an integrative literature review. BMC Med Educ. 2017 Dec 15;17(1):255. doi: 10.1186/s12909-017-1089-7.
- Kyle SD, Beattie L, Spiegelhalder K, Rogers Z, Espie CA. Altered emotion perception in insomnia disorder. Sleep. 2014 Apr 1;37(4):775-83. doi: 10.5665/sleep.3588.
- Kang Y, Moyle W, Venturato L. Korean nurses' attitudes towards older people with dementia in acute care settings. Int J Older People Nurs. 2011 Jun;6(2):143-52. doi: 10.1111/j.1748-3743.2010.00254.x. Epub 2010 Oct 28.
- Mercer SW, Reynolds WJ. Empathy and quality of care. Br J Gen Pract. 2002 Oct;52 Suppl(Suppl):S9-12.
- Owens JA. Sleep loss and fatigue in healthcare professionals. J Perinat Neonatal Nurs. 2007 Apr-Jun;21(2):92-100; quiz 101-2. doi: 10.1097/01.JPN.0000270624.64584.9d.
- Rosen IM, Gimotty PA, Shea JA, Bellini LM. Evolution of sleep quantity, sleep deprivation, mood disturbances, empathy, and burnout among interns. Acad Med. 2006 Jan;81(1):82-5. doi: 10.1097/00001888-200601000-00020.
- Sampson FC, Goodacre SW, O'Cathain A. The Reality of Pain Scoring in the Emergency Department: Findings From a Multiple Case Study Design. Ann Emerg Med. 2019 Oct;74(4):538-548. doi: 10.1016/j.annemergmed.2019.02.018. Epub 2019 Apr 5.
- Tempesta D, Socci V, De Gennaro L, Ferrara M. Sleep and emotional processing. Sleep Med Rev. 2018 Aug;40:183-195. doi: 10.1016/j.smrv.2017.12.005. Epub 2017 Dec 22.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PAIN-EASE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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