NCT05235035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

January 12, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

January 7, 2022

Last Update Submit

November 6, 2022

Conditions

Keywords

cognitive empathyhealth care professionalspain recognitionpain assessmentsleep misalignmentquality of care

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (7)

  • Prior Shift - Total Sleep Time in h compared between shift types

    1 day, 1 night

  • Nap Time during Shift in h compared between shift types

    1 day, 1 night

  • Empathy - Jefferson Scale of Physician Empathy

    1 day

  • Prior Shift Recovery Quality on 5 point Likert Scale compared between shift types

    1 day, 1 night

  • Comparison of speed in pain recognition task as cognitive performance during day or night shift

    1 day, 1 night

  • +2 more secondary outcomes

Study Arms (1)

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

Interventions

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

health care professionals

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may not qualify if:

  • refuse to participate
  • not working night shifts
  • no patient contact
  • working day and night shifts
  • health care professional with patient contact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Claude Bernard University

Lyon, France

Location

Related 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. No abstract available.

    PMID: 23336899BACKGROUND
  • 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.

    PMID: 16823021BACKGROUND
  • 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.

    PMID: 29488674BACKGROUND
  • 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.

    PMID: 25117004BACKGROUND
  • 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.

    PMID: 20015702BACKGROUND
  • Hojat, M. (2016). Empathy in health professions education and patient care.

    BACKGROUND
  • 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.

    PMID: 31236499BACKGROUND
  • 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.

    PMID: 29246213BACKGROUND
  • 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.

    PMID: 24899765BACKGROUND
  • 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.

    PMID: 21539719BACKGROUND
  • Mercer SW, Reynolds WJ. Empathy and quality of care. Br J Gen Pract. 2002 Oct;52 Suppl(Suppl):S9-12.

    PMID: 12389763BACKGROUND
  • 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.

    PMID: 9220806BACKGROUND
  • 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.

    PMID: 17505227BACKGROUND
  • 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.

    PMID: 16377826BACKGROUND
  • 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.

    PMID: 30955987BACKGROUND
  • 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.

    PMID: 29395984BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Shift Work Schedule

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Personnel Staffing and SchedulingPersonnel ManagementOrganization and AdministrationHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2022

First Posted

February 10, 2022

Study Start

January 12, 2022

Primary Completion

June 30, 2022

Study Completion

November 4, 2022

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations