Smoking Cessation, Anxiety, Pain Relationship

May 22, 2020 updated by: Arzu Esen Tekeli, Yuzuncu Yıl University

Preoperative Smoking Cessation, Preoperative Anxiety, Postoperative Anxiety and Pain Relationship

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tuşba
      • Van, Tuşba, Turkey, 65080
        • Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation
      • Van, Tuşba, Turkey, 65080
        • Van Yüzüncü Yil University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: smokers (S)
Preoperative anxiety high score suggests stress related to surgery and anesthesia. High anxiety scores independent of post-operative pain showed smoking withdrawal.
ACTIVE_COMPARATOR: non smokers (NS)
Preoperative anxiety high score suggests stress related to surgery and anesthesia. High anxiety scores independent of post-operative pain showed smoking withdrawal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 2 hours
assesed with STAI form
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scores
Time Frame: 2 hours
independent of anxiety, assesed with VAS scores
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Arzu Esen Tekeli, MD, yuzuncu yil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 17, 2018

Primary Completion (ACTUAL)

February 18, 2019

Study Completion (ACTUAL)

January 13, 2020

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (ACTUAL)

May 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

I do not want to share before publishing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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