Experimental PainNCT00314392
Gender, Pain, and Placebo Analgesia
A study testing Information (behavior) in people with Experimental Pain, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The response to standard pain stimuli in males and females is investigated, together with the effect of informing participants about the effect of a painkiller. Physiological response to pain is recorded. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Experimental Pain
- What is being tested?
- Information (behavior)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 74 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2006to Dec 2007
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years, healthy
Who cannot join
- pregnant, earlier serious disease or injury,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Participant Gender, Experimenter Gender, and Drug-Related Information on Placebo Analgesia
The response to standard pain stimuli in males and females is investigated, together with the effect of informing participants about the effect of a painkiller. Physiological response to pain is recorded.
Read the detailed description
The social context in which pain is reported has been found to modulate pain. Specifically, male participants reporting pain to female observers report significantly lower pain levels compared to male participants reporting to male observers. Female participants seem less affected by social context. This is a methodological problem in the study of pain and has consequences in the development of new drugs, and for pain research in general.
The present study has two aims: To investigate whether social context affects also the placebo response to pain, i.e. the reduced pain often observed after administration of a an inert substance the participants believes to be a painkiller. It is hypothesized that placebo analgesia will be larger in males reporting pain to females. Secondly, heart rate variability and skin conductance, measures of parasympathetic and sympathetic activity, will be recorded, to investigate if social context affects not only pain report, but also pain response.
- Conditions
- Experimental Pain
- Being tested
- Information (behavior)
- Keywords
- Experimental pain, Placebo analgesia, Heart rate variability, Skin conductance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information (behavior)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain report, heart rate variability, skin conductance
Secondary outcomes (1)
Subjective arousal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startSep 2006
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Experimental PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, University of Tromso
- Investigators
- Magne Arve Flaten, PhD, Principal investigator, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314392
- Sponsor's protocol ID
- Placebo
- Status last verified
- Feb 2008
- First submitted
- 11 Apr 2006
- Last updated
- 6 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Participant Gender, Experimenter Gender, and Drug-Related Information on Placebo Analgesia
- ClinicalTrials.gov ID
- NCT00314392
- Acronym / sponsor ID
- Placebo
- Conditions
- Experimental Pain
- Keywords
- Experimental pain, Placebo analgesia, Heart rate variability, Skin conductance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- The Research Council of Norway, University of Tromso
- Study start
- Sep 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 13 Apr 2006 (estimated)
- 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.
The response to standard pain stimuli in males and females is investigated, together with the effect of informing participants about the effect of a painkiller. Physiological response to pain is recorded.
Detailed description
The social context in which pain is reported has been found to modulate pain. Specifically, male participants reporting pain to female observers report significantly lower pain levels compared to male participants reporting to male observers. Female participants seem less affected by social context. This is a methodological problem in the study of pain and has consequences in the development of new drugs, and for pain research in general.
The present study has two aims: To investigate whether social context affects also the placebo response to pain, i.e. the reduced pain often observed after administration of a an inert substance the participants believes to be a painkiller. It is hypothesized that placebo analgesia will be larger in males reporting pain to females. Secondly, heart rate variability and skin conductance, measures of parasympathetic and sympathetic activity, will be recorded, to investigate if social context affects not only pain report, but also pain response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-40 years, healthy
Key exclusion criteria (1 listed)
- pregnant, earlier serious disease or injury,
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 |
|---|---|---|
| Information (behavior) | Behavioural | – |
Primary outcome
Pain report, heart rate variability, skin conductance
1 secondary outcome
Subjective arousal
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 Feb 2008.
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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.
Magne Arve Flaten, PhD principal investigator
University of Tromso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information (behavior) in people with Experimental Pain, run by University Hospital of North Norway at 1 site in Norway.
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 Feb 2008. 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 Norway. 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?
Pain report, heart rate variability, skin conductance. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2008.