Is There a Relationship Between Stress Tolerance and Anal... | NCT03227315

Studies
Is There a Relationship Between Stress Tolerance and Analgesic Consumption in Obese Patients?

NCT03227315

Sponsor

Tokat Gaziosmanpasa University

Status

Unknown status

Last Update Posted

Jul 24, 2017Actual

Enrollment

69Estimated

Phase

Not provided

Conditions

Distress Tolerance

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2017Actual

Primary Completion Date

Nov 20, 2017Estimated

Completion Date

Dec 10, 2017Estimated

First Submitted Date

Jul 20, 2017

First Submission Date that Met QC Criteria

Jul 21, 2017

First Posted Date

Jul 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2017

Last Update Posted Date

Jul 24, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

69Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	one time in four months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between 18 and 60 years
Planned to sleeve gastrectomy
An American Society of Anesthesiologists score of 1 or 2 BMI>30

Exclusion Criteria:

Psychiatric diseases
Rejected to participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

The Patients that will happen sleeve gastrectomy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hakan Tapar	Contact	+9005056844496		hakantapar@hotmail.com
Hakan Tapar	Contact	+9005056844496		akantapar@hotmail.com

Overall Officials

Name	Affiliation	Role
Hakan Tapar	Gaziosmanpasa university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gaziosmanpasa University	Recruiting	Tokat Province		60200	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided