PainNCT02727244
The Association Between Pain Catastrophizing Scale Score and Postspinal Headache
An observational study of Pain and Headache, run by Tokat Gaziosmanpasa University.
Trial summary
This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- What is being tested?
- urgent or elective cesarean section
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2016to 15 Apr 2017
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: women with pregnancy whose planned to undergo urgent or elective cesarean section
Who may be able to join
- American Society of Anesthesiologists score of I, II, III
- without a history of cerebrovascular diseases
- without any presence of psychiatric diseases
Who cannot join
- severe liver, kidney and cardiovascular diseases
- peripheral arterial diseases
- a history of allergy to local anesthetics
- patients without cooperation
- not to participate in the study
- presence of neurologic or neuromuscular diseases
About this study
Official title: Is There an Association Between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia?
This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia.
Read the detailed description
This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia. Patients were asked to fill the questionnaire booklet including Pain Catastrophizing Scale, Beck Depression Inventory and Beck Anxiety Inventory before elective cesarean section in preoperative room in operating theater. In postoperative second and fourth day, patients will call by phone and be asked to have headache or any complaints. The intensity of headache will evaluate by using visual analog scale. Age, gender, and visual analog scale scores will be recorded.
- Being tested
- urgent or elective cesarean section
- Keywords
- Pain Catastrophizing Scale
- Medical subject headings
- Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urgent or elective cesarean sectionProcedure or surgery
a kind of surgical procedure to deliver a baby
What is being measured
The primary outcome is the main question the study is designed to answer.
pain catastrophizing scale score
numerical value obtained using pain catastrophizing scale score
Measured: one time in one year
Secondary outcomes (3)
Beck depression inventory
numerical value obtained using Beck depression inventory
Measured: one time in one year
beck anxiety inventory
numerical value obtained using beck anxiety inventory
Measured: one time in one year
visual analog scale score
numerical value obtained using visual analog scale score
Measured: one time in one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start15 Apr 2016
- Primary completion15 Apr 2017
- Study completion15 Apr 2017
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Suren, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727244
- Sponsor's protocol ID
- 16-KAEK-071
- Status last verified
- Jun 2018
- First submitted
- 30 Mar 2016
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There an Association Between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia?
- ClinicalTrials.gov ID
- NCT02727244
- Acronym / sponsor ID
- 16-KAEK-071
- Keywords
- Pain Catastrophizing Scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 4 Apr 2016 (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.
This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia.
Detailed description
This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia. Patients were asked to fill the questionnaire booklet including Pain Catastrophizing Scale, Beck Depression Inventory and Beck Anxiety Inventory before elective cesarean section in preoperative room in operating theater. In postoperative second and fourth day, patients will call by phone and be asked to have headache or any complaints. The intensity of headache will evaluate by using visual analog scale. Age, gender, and visual analog scale scores will be recorded.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women with pregnancy whose planned to undergo urgent or elective cesarean section
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists score of I, II, III
- without a history of cerebrovascular diseases
- without any presence of psychiatric diseases
Key exclusion criteria (6 listed)
- severe liver, kidney and cardiovascular diseases
- peripheral arterial diseases
- a history of allergy to local anesthetics
- patients without cooperation
- not to participate in the study
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 |
|---|---|---|
| urgent or elective cesarean sectiona kind of surgical procedure to deliver a baby | Procedure or surgery | – |
Primary outcome
pain catastrophizing scale score
Time frame: one time in one year
numerical value obtained using pain catastrophizing scale score
3 secondary outcomes
Beck depression inventory
Time frame: one time in one year
beck anxiety inventory
Time frame: one time in one year
visual analog scale score
Time frame: one time in one year
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 19 Jun 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Headache, run by Tokat Gaziosmanpasa University.
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 3 inclusion and 6 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 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 catastrophizing scale score (time frame: one time in one year). 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 19 Jun 2018.