Impact of Gender on Perceived Postoperative Pain

NCT03968497 | Completed

• 1 other identifier: Gender and pain
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is a common problem after surgical procedures with many patients afflicted worldwide. Fundamental challenges are the complexity of measuring pain appropriately, and the many associated possible confounders. Over the last decades, gender of the investigator has been identified as a conceivable bias in the assessment and management of pain in experimental, as well as, clinical research. However, to the investigators knowledge this issue has not so far been systematically investigated in a postoperative setting. The objective of this study was to investigate whether the gender of the investigator has an impact on the reported levels of pain intensity after acute or scheduled surgery. In this prospective paired cross-over study, two investigators of opposite gender independently obtained individually reported pain intensity levels in each study patient based on three different methods of pain assessment the Visual Analogue Scale (VAS), the Numeric Rating Scale (NRS), and the Painmatcher® (PM) technique based on electrical stimulation, in a postoperative study setting at a large urban university hospital in southern Sweden.

Conditions

Postoperative Pain

Keywords

pain; gender; visual analog scale; numeric rating scale

Outcome Measures

Primary Outcomes (3)

• Postoperative pain assessment with visual analogue scale (VAS).

  The Visual Analogue Scale (VAS), a 101-point scale for evaluating pain which consists of a 100-millimetre scale ranging from 0 (no pain at all) to 100 (worst imaginable pain). Individual scores were recorded with one decimal number (range 0-10.0).

  From arrival at the PACU until approximately 15-minutes after arrival.

• Postoperative pain assessment with numeric rating scale (NRS).

  The Numeric Rating Scale (NRS) for evaluating pain. The rating is verbal, and the subject is asked to estimate current pain intensity on an 11-point scale, where 0 indicates no pain at all and 10 the worst imaginable pain.

  From arrival at the PACU until approximately 15-minutes after arrival.

• Postoperative pain assessment with Painmatcher® (PM).

  The Painmatcher® (CEFAR Medical AB, Lund, Sweden) is an instrument developed for assessment of pain using a mild electrical stimulus, until this pain correlates to the pain already experienced for example postoperative pain.

  From arrival at the PACU until approximately 15-minutes after arrival.

Study Arms (1)

Postoperative pain assessment

OTHER

Postoperative pain evaluation by a female and a male investigator, respectively at approximately 15-minute intervals.

Other: Postoperative pain assessment with female investigator; Other: Postoperative pain assessment with male investigator

Interventions

Postoperative pain assessment with female investigator OTHER

Postoperative pain evaluation by a female investigator by using visual analogue scale, numeric rating scale and Painmatcher®.

Also known as: Visual analogue scale, Numeric rating scale, Painmatcher®

Postoperative pain assessment

Postoperative pain assessment with male investigator OTHER

Postoperative pain evaluation by a male investigator by using visual analogue scale, numeric rating scale and Painmatcher®.

Also known as: Visual analogue scale, Numeric rating scale, Painmatcher®

Postoperative pain assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ongoing PACU care after recent surgery, cognitive and linguistic abilities to understand instructions and participate in the study, and perceived postoperative pain.

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Three Post Anaesthesia Care Units (PACUs) at Skåne University Hospital in Malmö, Sweden

Malmo, Sweden

Location

Related Publications (1)

• Engskov AS, Ydrefors A, El-Jaleb K, Akeson J. Prospective paired crossover evaluation of potential impact of investigator gender on perceived pain intensity early after acute or scheduled surgery. Biol Sex Differ. 2023 Apr 25;14(1):23. doi: 10.1186/s13293-023-00508-9.

  PMID: 37095547 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain; Coitus

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Sexual Behavior; Behavior

Study Officials

• Anna Sellgren Engskov, PhD student

  IKVM, Lund University

  PRINCIPAL INVESTIGATOR

• Jonas Åkeson, Professor

  IKVM, Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Half of the patients were first evaluated by the female and then by the male investigator, and the other half the other way around, according to a cross-over study design but with a single group of subjects.

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 30, 2019
• Study Start: September 11, 2018
• Primary Completion: November 16, 2018
• Study Completion: November 16, 2018
• Last Updated: June 6, 2019

Record last verified: 2019-06

Locations

SE (1)