Distress ToleranceNCT03227315
Is There a Relationship Between Stress Tolerance and Analgesic Consumption in Obese Patients?
An observational study of Distress Tolerance, run by Tokat Gaziosmanpasa University at 2 sites in Turkey (Türkiye).
Trial summary
Preoperative anxiety level of patients affects postoperative analgesic consumption. However, there were no studies that showed a relationship between the level of stress tolerance and analgesic consumption in the literature. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Distress Tolerance
- How many people
- 69 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Jul 2017to 10 Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The Patients that will happen sleeve gastrectomy
Who may be able to join
- Between 18 and 60 years
- Planned to sleeve gastrectomy
- An American Society of Anesthesiologists score of 1 or 2 BMI>30
Who cannot join
- Psychiatric diseases
- Rejected to participation
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Gaziosmanpasa University
Tokat Province, 60200
Hakan Tapar, Assist.Prof., +905056844496, hakantapar@hotmail.com
- Recruiting
Hakan Tapar
Tokat Province, 60200
Hakan Tapar, 03562129500-3496, hakantapar@hotmail.com
About this study
Preoperative anxiety level of patients affects postoperative analgesic consumption. However, there were no studies that showed a relationship between the level of stress tolerance and analgesic consumption in the literature. In this study, investigators wanted to investigate the effect of stress tolerance on analgesic consumption of patient.
Read the detailed description
After approval, patients enrolled in the study is invited to complete the Pain Catastrophizing Scale questionnaire, Distress Tolerance Scale and Beck anxiety scale.After surgery, VAS scores of the patients will be evaluated (in the recovery room, 2,6,12 and 24 hours). and patients with VAS> 3 will receive 2 mg of morphine.The relationship between total analgesic consumption and the stress tolerance will be evaluated.The study will be performed with 69 sleeve gastrectomy patients(BMI>30).
- Conditions
- Distress Tolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of patient anxiety tolerance on analgesic consumption
Assessment of analgesic consumption according to the patient's anxiety. tolerance.The distress tolerance scale will be used for this.
Measured: one time in four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start20 Jul 2017
- Primary completion20 Nov 2017 (estimated)
- Study completion10 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress ToleranceStudies 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
- 69 participants (estimated)
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, Principal investigator, Gaziosmanpasa university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227315
- Sponsor's protocol ID
- 17-KAEK-077
- Status last verified
- Jul 2017
- First submitted
- 20 Jul 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Relationship Between Stress Tolerance and Analgesic Consumption in Obese Patients?
- ClinicalTrials.gov ID
- NCT03227315
- Acronym / sponsor ID
- 17-KAEK-077
- Conditions
- Distress Tolerance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 20 Nov 2017 (estimated)
- Study completion
- 10 Dec 2017 (estimated)
- First posted
- 24 Jul 2017 (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.
Preoperative anxiety level of patients affects postoperative analgesic consumption. However, there were no studies that showed a relationship between the level of stress tolerance and analgesic consumption in the literature. In this study, investigators wanted to investigate the effect of stress tolerance on analgesic consumption of patient.
Detailed description
After approval, patients enrolled in the study is invited to complete the Pain Catastrophizing Scale questionnaire, Distress Tolerance Scale and Beck anxiety scale.After surgery, VAS scores of the patients will be evaluated (in the recovery room, 2,6,12 and 24 hours). and patients with VAS> 3 will receive 2 mg of morphine.The relationship between total analgesic consumption and the stress tolerance will be evaluated.The study will be performed with 69 sleeve gastrectomy patients(BMI>30).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The Patients that will happen sleeve gastrectomy
Key inclusion criteria (3 listed)
- Between 18 and 60 years
- Planned to sleeve gastrectomy
- An American Society of Anesthesiologists score of 1 or 2 BMI>30
Key exclusion criteria (2 listed)
- Psychiatric diseases
- Rejected to participation
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
The effect of patient anxiety tolerance on analgesic consumption
Time frame: one time in four months
Assessment of analgesic consumption according to the patient's anxiety. tolerance.The distress tolerance scale will be used for this.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- 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.
Hakan Tapar principal investigator
Gaziosmanpasa university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distress Tolerance, run by Tokat Gaziosmanpasa University at 2 sites 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 2 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 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Hakan Tapar (+9005056844496, hakantapar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of patient anxiety tolerance on analgesic consumption (time frame: one time in four 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 24 Jul 2017.