Impact of Investigator Gender on Perceived Pain Intensity After Acute or Scheduled Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- Postoperative pain assessment with numeric rating scale (NRS).
研究概览
简要总结
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.
详细描述
Study design This prospective paired clinical cross-over study was carried out in three different Post Anaesthesia Care Units (PACUs) at Skåne University Hospital in Malmö, Sweden. All patients were supervised and managed according to the local standard of care. The measurements were accomplished during daytime over a ten-week study period.
Two investigators, one male and one female, performed the measurements and collected the study data. They were both senior medical students at the same level and of similar age (30 and 38 years, respectively). Postoperative levels of individual pain intensity were obtained as early after arrival at the PACU as possible, depending on how soon the study patient was alert enough to participate. Pain was evaluated in each study patient at two consecutive study sessions at approximately 15-minute intervals, according to a predefined study protocol. Half of the study participants 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.
Pain evaluation Postoperative pain intensity was assessed with three different study techniques in each study patient.
The Visual Analogue Scale (VAS), is a long-established technique for measuring pain and 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).
The Numeric Rating Scale (NRS) is another well-known and reliable method for evaluating pain in clinical practice. 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. The study patients were asked to choose integers only, and no decimal numbers were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ongoing PACU care after recent surgery, cognitive and linguistic abilities to understand instructions and participate in the study, and perceived postoperative pain.
排除标准
- •Fulfilled inclusion criteria but decline to participate.
研究组 & 干预措施
Postoperative pain assessment
Postoperative pain evaluation by a female and a male investigator, respectively at approximately 15-minute intervals.
干预措施: Postoperative pain assessment with male investigator (Other)
Postoperative pain assessment
Postoperative pain evaluation by a female and a male investigator, respectively at approximately 15-minute intervals.
干预措施: Postoperative pain assessment with female investigator (Other)
结局指标
主要结局
Postoperative pain assessment with numeric rating scale (NRS).
时间窗: From arrival at the PACU until approximately 15-minutes after arrival.
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.
Postoperative pain assessment with Painmatcher® (PM).
时间窗: From arrival at the PACU until approximately 15-minutes after arrival.
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.
Postoperative pain assessment with visual analogue scale (VAS).
时间窗: From arrival at the PACU until approximately 15-minutes after arrival.
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).
次要结局
未报告次要终点