PainNCT03609788
Validation of the Turkish Version of the Pain Sensitivity Questionnaire
An observational study of Pain, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The Pain Sensitivity Questionnaire(PSQ) is a self-rating measure for the assessment of pain sensitivity and has been developed by Dr. R. Ruscheweyh in Germany. It consists of 17 items rated from 0, not at all painful to 10, most severe pain imaginable. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pain
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2018to 15 Dec 2018
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients scheduled to undergo a low back interventional procedure
Who may be able to join
- ASA 1-2
- adult chronic low back pain patients having pain for greater than 3 months
Who cannot join
- Failed back surgery syndrome,
- Morbid obesity (body mass index, >40),
- Being a non-Turkish speaker,
- Substance abuse disorder,
- Major psychiatric disorder (eg, severe depression, bipolar disorder, Axis II personality disorder, and schizophrenia).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University
Istanbul, 34230
ferda yılmaz inal
About this study
Official title: Validation of the Turkish Version of the Pain Sensitivity Questionnaire in Patients With Chronic Pain
The Pain Sensitivity Questionnaire(PSQ) is a self-rating measure for the assessment of pain sensitivity and has been developed by Dr. R. Ruscheweyh in Germany. It consists of 17 items rated from 0, not at all painful to 10, most severe pain imaginable. The validation of the Turkish version of PSQ is needed, in order to measure pain sensitivity among Turkish people.
- Conditions
- Pain
- Keywords
- pain sensitivity
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of pain intensity in Turkish people using The Turkish version of the PSQ
Measurement of pain intensity in Turkish people using The Turkish version of the PSQ, consisting of 17 items, describing different daily life situations with a scoring from 0(not painful) to 10 (worst pain imaginable) on a numeric rating scale. A PSQ total score is between 0-10, the higher score, the more patient's pain sensitivity.
Measured: 1 day
Pain Catastrophizing Scale
This scale is used in order to assess the state of mind of patients in pain through a comprehensive evaluation instrument that encompasses the different perspectives on catastrophizing. It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52.24 The higher the score, the more catastrophizing thoughts are present.
Measured: 1 day
Beck Anxiety Inventory
This scale, consisting of 21 items, is a self-report measure of anxiety. Score of 0-21 shows low anxiety. Score of 22-35 shows moderate anxiety. Score of 36 and above shows potentially concerning levels of anxiety.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start15 May 2018
- Primary completion15 Dec 2018 (estimated)
- Study completion15 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferda Yilmaz Inal, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609788
- Sponsor's protocol ID
- 71306642-050.01.04-10/12
- Status last verified
- Dec 2018
- First submitted
- 25 Jul 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Turkish Version of the Pain Sensitivity Questionnaire in Patients With Chronic Pain
- ClinicalTrials.gov ID
- NCT03609788
- Acronym / sponsor ID
- 71306642-050.01.04-10/12
- Conditions
- Pain
- Keywords
- pain sensitivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 15 Dec 2018 (estimated)
- First posted
- 1 Aug 2018 (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.
The Pain Sensitivity Questionnaire(PSQ) is a self-rating measure for the assessment of pain sensitivity and has been developed by Dr. R. Ruscheweyh in Germany. It consists of 17 items rated from 0, not at all painful to 10, most severe pain imaginable. The validation of the Turkish version of PSQ is needed, in order to measure pain sensitivity among Turkish people.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo a low back interventional procedure
Key inclusion criteria (2 listed)
- ASA 1-2
- adult chronic low back pain patients having pain for greater than 3 months
Key exclusion criteria (5 listed)
- Failed back surgery syndrome,
- Morbid obesity (body mass index, >40),
- Being a non-Turkish speaker,
- Substance abuse disorder,
- Major psychiatric disorder (eg, severe depression, bipolar disorder, Axis II personality disorder, and schizophrenia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of pain intensity in Turkish people using The Turkish version of the PSQ
Time frame: 1 day
Measurement of pain intensity in Turkish people using The Turkish version of the PSQ, consisting of 17 items, describing different daily life situations with a scoring from 0(not painful) to 10 (worst pain imaginable) on a numeric rating scale. A PSQ total score is between 0-10, the higher score, the more patient's pain sensitivity.
Pain Catastrophizing Scale
Time frame: 1 day
This scale is used in order to assess the state of mind of patients in pain through a comprehensive evaluation instrument that encompasses the different perspectives on catastrophizing. It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52.24 The higher the score, the more catastrophizing thoughts are present.
Beck Anxiety Inventory
Time frame: 1 day
This scale, consisting of 21 items, is a self-report measure of anxiety. Score of 0-21 shows low anxiety. Score of 22-35 shows moderate anxiety. Score of 36 and above shows potentially concerning levels of anxiety.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Dec 2018. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ferda yılmaz inal (00905058207650, ferdayilmazinal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pain intensity in Turkish people using The Turkish version of the PSQ (time frame: 1 day). 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?
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 13 Dec 2018.