Pain Clinical Trial
— PAIN-EASEOfficial 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
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 |
Verified date | November 2022 |
Source | Claude Bernard University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Claude Bernard University | Lyon |
Lead Sponsor | Collaborator |
---|---|
Claude Bernard University |
France,
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* Note: There are 16 references in all — Click here to view all references
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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