Postoperative PainG-PAINNCT03968497
Impact of Gender on Perceived Postoperative Pain
A study testing Postoperative pain assessment with female investigator and Postoperative pain assessment with male investigator in people with Postoperative Pain, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Postoperative pain assessment with female investigator and Postoperative pain assessment with male investigator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteSweden
- Study dates
- 11 Sep 2018to 16 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ongoing PACU care after recent surgery, cognitive and linguistic abilities to understand instructions and participate in the study, and perceived postoperative pain.
Who cannot join
- Fulfilled inclusion criteria but decline to participate.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Three Post Anaesthesia Care Units (PACUs) at Skåne University Hospital in Malmö, Sweden
Malmö
About this study
Official title: Impact of Investigator Gender on Perceived Pain Intensity After Acute or Scheduled Surgery
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.
Read the detailed description
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.
The Painmatcher® (PM) is a rather new instrument (CEFAR Medical AB, Lund, Sweden) developed for assessment of pain with a mild electrical stimulus.
The study patients were told to press two rubber electrodes of the device between their thumb and index finger and to release them as soon as the gradually increasing systaltic sensations in the finger tips induced by electrical current were considered comparable to their current intensity of postoperative pain. On release of the buttons, the local pain immediately ceases and a corresponding integer-based score is displayed on the device. Each patient went through three measurements with the device during each study session.
Study procedures Each study session started with a short interview, where the study participants were asked to shortly describe, in words of their own, the main character of their postoperative pain. They were then requested to rate their current intensity level of pain with the three different study techniques (VAS, PM and NRS in mentioned order). The study patients were equally informed verbally on how to carry out the pain measurements and were blinded to the study aim (of evaluating potential impact of investigator gender). Additional information on surgical and anaesthetic procedures, including current analgesic medication, was obtained from the peri-operative database of the hospital, and from individual patient records.
- Conditions
- Postoperative Pain
- Being tested
- Postoperative pain assessment with female investigator, Postoperative pain assessment with male investigator
- Keywords
- pain, gender, visual analog scale, numeric rating scale
- Medical subject headings
- Pain, Postoperative, Pain, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative pain assessment with female investigatorOther
Also called Visual analogue scale, Numeric rating scale, Painmatcher®
Postoperative pain evaluation by a female investigator by using visual analogue scale, numeric rating scale and Painmatcher®.
Postoperative pain assessment with male investigatorOther
Also called Visual analogue scale, Numeric rating scale, Painmatcher®
Postoperative pain evaluation by a male investigator by using visual analogue scale, numeric rating scale and Painmatcher®.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative pain assessment | Other | Postoperative pain evaluation by a female and a male investigator, respectively at approximately 15-minute intervals. Receives: Other: Postoperative pain assessment with female investigator; Other: Postoperative pain assessment with male investigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: From arrival at the PACU until approximately 15-minutes after arrival.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start11 Sep 2018
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Sellgren Engskov, PhD student, Principal investigator, IKVM, Lund UniversityJonas Åkeson, Professor, Principal investigator, IKVM, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968497
- Sponsor's protocol ID
- Gender and pain
- Acronym
- G-PAIN
- Status last verified
- Jun 2019
- First submitted
- 24 May 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37095547
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Investigator Gender on Perceived Pain Intensity After Acute or Scheduled Surgery
- ClinicalTrials.gov ID
- NCT03968497
- Acronym / sponsor ID
- G-PAIN / Gender and pain
- Conditions
- Postoperative Pain
- Keywords
- pain, gender, visual analog scale, numeric rating scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The Painmatcher® (PM) is a rather new instrument (CEFAR Medical AB, Lund, Sweden) developed for assessment of pain with a mild electrical stimulus.
The study patients were told to press two rubber electrodes of the device between their thumb and index finger and to release them as soon as the gradually increasing systaltic sensations in the finger tips induced by electrical current were considered comparable to their current intensity of postoperative pain. On release of the buttons, the local pain immediately ceases and a corresponding integer-based score is displayed on the device. Each patient went through three measurements with the device during each study session.
Study procedures Each study session started with a short interview, where the study participants were asked to shortly describe, in words of their own, the main character of their postoperative pain. They were then requested to rate their current intensity level of pain with the three different study techniques (VAS, PM and NRS in mentioned order). The study patients were equally informed verbally on how to carry out the pain measurements and were blinded to the study aim (of evaluating potential impact of investigator gender). Additional information on surgical and anaesthetic procedures, including current analgesic medication, was obtained from the peri-operative database of the hospital, and from individual patient records.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Postoperative pain assessment | Other | Other: Postoperative pain assessment with female investigator, Other: Postoperative pain assessment with male investigatorPostoperative pain evaluation by a female and a male investigator, respectively at approximately 15-minute intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ongoing PACU care after recent surgery, cognitive and linguistic abilities to understand instructions and participate in the study, and perceived postoperative pain.
Key exclusion criteria (1 listed)
- Fulfilled inclusion criteria but decline to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative pain assessment with female investigatorAlso: Visual analogue scale, Numeric rating scale, Painmatcher®Postoperative pain evaluation by a female investigator by using visual analogue scale, numeric rating scale and Painmatcher®. | Other | Postoperative pain assessment |
| Postoperative pain assessment with male investigatorAlso: Visual analogue scale, Numeric rating scale, Painmatcher®Postoperative pain evaluation by a male investigator by using visual analogue scale, numeric rating scale and Painmatcher®. | Other | Postoperative pain assessment |
Primary outcome
Postoperative pain assessment with visual analogue scale (VAS).
Time frame: 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).
Postoperative pain assessment with numeric rating scale (NRS).
Time frame: 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).
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Derived from this study: PubMed 37095547Engskov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Sellgren Engskov, PhD student principal investigator
IKVM, Lund University
Jonas Åkeson, Professor principal investigator
IKVM, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative pain assessment with female investigator and Postoperative pain assessment with male investigator in people with Postoperative Pain, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain assessment with visual analogue scale (VAS). (time frame: From arrival at the PACU until approximately 15-minutes after arrival.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.