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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05235035
Other study ID # PAIN-EASE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 12, 2022
Est. completion date November 4, 2022

Study information

Verified date November 2022
Source Claude Bernard University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 4, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Claude Bernard University Lyon

Sponsors (1)

Lead Sponsor Collaborator
Claude Bernard University

Country where clinical trial is conducted

France, 

References & Publications (16)

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. — View Citation

Gélinas 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hojat, M. (2016). Empathy in health professions education and patient care.

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Mercer SW, Reynolds WJ. Empathy and quality of care. Br J Gen Pract. 2002 Oct;52 Suppl:S9-12. — View Citation

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. — View Citation

Owens JA. Sleep loss and fatigue in healthcare professionals. J Perinat Neonatal Nurs. 2007 Apr-Jun;21(2):92-100; quiz 101-2. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of pain recognition accuracy during day or 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
Primary Comparison in pain intensity on NPRS - numerical pain rating scale 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 Prior Shift - Total Sleep Time in h compared between shift types 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
Secondary Nap Time during Shift in h compared between shift types 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
Secondary Empathy - Jefferson Scale of Physician Empathy 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
Secondary Prior Shift Recovery Quality on 5 point Likert Scale compared between shift types 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
Secondary Comparison of speed in pain recognition task as cognitive performance during day or night shift 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
Secondary Health Care Professional Work Expertise in years Self-reported years of work experience as a health care professional 1 day
Secondary Shift Work Expertise in years Self-reported years of work experience in a shift work system 1 day
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