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Smoking Cessation, Anxiety, Pain Relationship

Primary Purpose

Smoking Cessation, Anxiety, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Smoking Cessation focused on measuring Smoking Cessation, anxiety, pain, VAS Scores, STAI Values

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA I,II patients
  • planned Rhinoplasti cases
  • accepted participating study

Exclusion Criteria:

  • Patients with chronic systemic disorders,
  • ASA III and above situation
  • emergency and bleeding cases,
  • patients with any cardiac and neurological disorders,
  • refused to participate in the study

Sites / Locations

  • Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation
  • Van Yuzuncu Yil University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

smokers (S)

non smokers (NS)

Arm Description

Outcomes

Primary Outcome Measures

Anxiety
assesed with STAI form

Secondary Outcome Measures

pain scores
independent of anxiety, assesed with VAS scores

Full Information

First Posted
May 18, 2020
Last Updated
May 22, 2020
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT04405219
Brief Title
Smoking Cessation, Anxiety, Pain Relationship
Official Title
Preoperative Smoking Cessation, Preoperative Anxiety, Postoperative Anxiety and Pain Relationship
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 17, 2018 (Actual)
Primary Completion Date
February 18, 2019 (Actual)
Study Completion Date
January 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Smoking, anxiety and pain are clearly related conditions. We aimed to reveal the relationship between smoking cessation before surgery and preoperative anxiety, postoperative anxiety and pain in chronic smokers. METHODS ASA I-II group patients without chronic disease and history of drug use were included in the study. Those who did not want to participate in the study, patients with ASA III and above were excluded from the study. The patients were randomized into 2 groups: smokers (Group S, n = 60) and non-smokers (Group NS, n = 60). Group S was asked to quit smoking 2 weeks before the operation. Preoperative period and postoperative 0, 2, 4. And 6. hour Spielberger State-Trait Anxiety Inventory (STAI) values, postop 0., 2., 4., 6. hour Visual Analogue Scale (VAS) values were recorded.
Detailed Description
it has been revealed in the current study that smoking, pain and anxiety are interrelated with each other. In the preoperative period, high anxiety scores are related to surgery and anesthesia stress. High anxiety scores in the smoker group both in the preoperative period and in the postoperative period are associated with smoking cessation. While the pain scores were similar in the postoperative period, high anxiety scores strengthened the idea of smoking withdrawal and this study gained value. We believe that future studies with a large number of patients, with different parameters and multiple centers will strengthen the results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Anxiety, Pain
Keywords
Smoking Cessation, anxiety, pain, VAS Scores, STAI Values

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
smokers (S)
Arm Type
Sham Comparator
Arm Title
non smokers (NS)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain
Intervention Description
Preoperative anxiety high score suggests stress related to surgery and anesthesia. High anxiety scores independent of post-operative pain showed smoking withdrawal.
Primary Outcome Measure Information:
Title
Anxiety
Description
assesed with STAI form
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
pain scores
Description
independent of anxiety, assesed with VAS scores
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA I,II patients planned Rhinoplasti cases accepted participating study Exclusion Criteria: Patients with chronic systemic disorders, ASA III and above situation emergency and bleeding cases, patients with any cardiac and neurological disorders, refused to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu Esen Tekeli, MD
Organizational Affiliation
yuzuncu yil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation
City
Van
State/Province
Tuşba
ZIP/Postal Code
65080
Country
Turkey
Facility Name
Van Yuzuncu Yil University
City
Van
State/Province
Tuşba
ZIP/Postal Code
65080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
I do not want to share before publishing

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Smoking Cessation, Anxiety, Pain Relationship

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