Chronic PainNCT02656264
The Chronic Pain Incidence After Elective and Urgent Cesarean Sections
An observational study of Chronic Pain, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine the effects of whether urgent or elective cesarean section on the occurrance of chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Chronic Pain
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2015to May 2016
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: * Female * 18 - 45 years of age * underwent elective or urgent cesarean section
Who may be able to join
- Female
- 18 - 45 years of age
- underwent elective or urgent cesarean section
Who cannot join
- not willing to participate in the study
- can not reach by phone
- use of anti-psychotic or anti-depressant drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University
Tokat Province, 60200
About this study
The purpose of this study is to determine the effects of whether urgent or elective cesarean section on the occurrance of chronic pain.
Read the detailed description
The purpose of this study is to determine the effects of whether urgent or elective cesarean section on the occurrance of chronic pain. Patients aged between 18 - 45 years whose underwent urgent or elective cesarean section will be invited to participate in the study. Preoperatively in operating theatre, patients will be asked to complete the pain catastrophizing scale (PCS) questionnaire. In postoperative 6 months after discharge, patients will be called by an investigator who is blind to the study to evaluate the presence of chronic pain. Patients will be asked to grade the pain that they suffer using a numeric rating scale for the intensity of pain.
- Conditions
- Chronic Pain
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric rating scale
Measured: One time when calling the patient, an avarage of three months
Secondary outcomes (2)
pain catastrophizing scale
Measured: one time in operating theatre, an avarage of three months
presence of chronic pain using numeric rating scale
Measured: One time when calling the patient, an avarage of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startMay 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Tapar, Tokat Gaziosmanpasa University
- Investigators
- Hakan Tapar, Assist.Prof., Principal investigator, Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656264
- Sponsor's protocol ID
- 15-KAEK-028
- Status last verified
- Apr 2017
- First submitted
- 24 Dec 2015
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chronic Pain Incidence After Elective and Urgent Cesarean Sections
- ClinicalTrials.gov ID
- NCT02656264
- Acronym / sponsor ID
- 15-KAEK-028
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Jan 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.
The purpose of this study is to determine the effects of whether urgent or elective cesarean section on the occurrance of chronic pain.
Detailed description
The purpose of this study is to determine the effects of whether urgent or elective cesarean section on the occurrance of chronic pain. Patients aged between 18 - 45 years whose underwent urgent or elective cesarean section will be invited to participate in the study. Preoperatively in operating theatre, patients will be asked to complete the pain catastrophizing scale (PCS) questionnaire. In postoperative 6 months after discharge, patients will be called by an investigator who is blind to the study to evaluate the presence of chronic pain. Patients will be asked to grade the pain that they suffer using a numeric rating scale for the intensity of pain.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- * Female * 18 - 45 years of age * underwent elective or urgent cesarean section
Key inclusion criteria (3 listed)
- Female
- 18 - 45 years of age
- underwent elective or urgent cesarean section
Key exclusion criteria (3 listed)
- not willing to participate in the study
- can not reach by phone
- use of anti-psychotic or anti-depressant drugs
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
numeric rating scale
Time frame: One time when calling the patient, an avarage of three months
2 secondary outcomes
pain catastrophizing scale
Time frame: one time in operating theatre, an avarage of three months
presence of chronic pain using numeric rating scale
Time frame: One time when calling the patient, an avarage of three months
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 20 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Hakan Tapar, Assist.Prof. principal investigator
Gaziosmanpasa University
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 Chronic Pain, run by Tokat Gaziosmanpasa 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 3 inclusion and 3 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 20 Oct 2017. 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?
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?
numeric rating scale (time frame: One time when calling the patient, an avarage of three months). 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 20 Oct 2017.