Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011597

Trial Description

start of 1:1-Block title

Title

Gender of investigator biases reporting of pain intensity:
A prospective study on surgical patients after sternotomy.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This prospective observational study with eight subgroups investigated whether 100 female and 100 male patients pain intensity report (on Numerical rating scale) after a surgical procedure (thoracotomy, e.g. for coronary surgery or valve replacement) differs when assessed by a medical examiner of the same or opposite gender at the first two postoperative days (twice daily in the morning and evening).

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011597
  •   2017/02/06
  •   [---]*
  •   no
  •   Approved
  •   4484-12, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   acute postoperative pain
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   female patients - female examiners:
    preoperative: anamnesis, assessment (NRS, questionaires: BDI, State and Trait anxiety)
    postoperative:
    day 1 morning: NRS, SES, nausea/ vomiting
    day 1 evening: NRS, SES, nausea/ vomiting
    day 2 morning: NRS, SES, nausea/ vomiting
    day 2 evening: NRS, SES, nausea/ vomiting
  •   male patients - female examiners:
    preoperative: anamnesis, assessment (NRS, questionaires: BDI, State and Trait anxiety)
    postoperative:
    day 1 morning: NRS, SES, nausea/ vomiting
    day 1 evening: NRS, SES, nausea/ vomiting
    day 2 morning: NRS, SES, nausea/ vomiting
    day 2 evening: NRS, SES, nausea/ vomiting
  •   female patients - male examiners:
    preoperative: anamnesis, assessment (NRS, questionaires: BDI, State and Trait anxiety)
    postoperative:
    day 1 morning: NRS, SES, nausea/ vomiting
    day 1 evening: NRS, SES, nausea/ vomiting
    day 2 morning: NRS, SES, nausea/ vomiting
    day 2 evening: NRS, SES, nausea/ vomiting
  •   male examiners - male patients:
    preoperative: anamnesis, assessment (NRS, questionaires: BDI, State and Trait anxiety)
    postoperative:
    day 1 morning: NRS, SES, nausea/ vomiting
    day 1 evening: NRS, SES, nausea/ vomiting
    day 2 morning: NRS, SES, nausea/ vomiting
    day 2 evening: NRS, SES, nausea/ vomiting
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

postoperative pain intensity in dependence of investigator gender

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

preoperative: anxiety, depression
postoperative: PONV

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/12/01
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   90   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Women: voluntariness, declaration of consent, elective heart surgery, sufficient German knowledge of German, between 40 and 90 years;
men: voluntariness, declaration of consent, elective heart surgery, sufficient German knowledge of German, between 40 and 90 years

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Exclusion criteria were any psychiatric disorders (e.g., known depression or BDI-II score ≥ 29 [see below]), chronic pain states (e.g., back pain, rheumatoid arthritis and fibromyalgia), patients taking opioids, missing language skills and states like dementia or confusion, as well as declination of participation. Postoperative exclusion criteria were ongoing analgosedation by means of ventilation via endotracheal tube, delirium or revocation of previous given consent.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin; Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Bochum
    • Mr.  Prof. Dr.  Peter  Zahn 
    • Bürkle-de-la-Camp Platz 1
    • 44789  Bochum
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   00234-3020
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • 2)Klinik für Anästhesiologie, Operative Intensivmedizin und Schmerztherapie Universitätsklinikum Münster
    • Ms.  Prof. Dr.  Esther  Pogatzki-Zahn 
    • Albert Schweitzer Campus 1, GB A1
    • 48143  Münster
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin; Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Bochum
    • Ms.  Dr.  Christine  Meyer-Frießem 
    • Bürkle-de-la-Camp Platz 1
    • 44789  Bochum
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin; Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Bochum
    • Ms.  Dr.  Christine  Meyer-Frießem 
    • Bürkle-de-la-Camp Platz 1
    • 44789  Bochum
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin; Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil, Bochum
    • Mr.  Prof. Dr.  Peter  Zahn 
    • Bürkle-de-la-Camp Platz 1
    • 44789  Bochum
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   00234-3020
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2015/07/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.