Smoking CessationNCT04405219
Smoking Cessation, Anxiety, Pain Relationship
A study testing The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain in people with Smoking Cessation and Anxiety, run by Yuzuncu Yil University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Anxiety, Pain
- What is being tested?
- The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 17 Feb 2018to 13 Jan 2020
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I,II patients
- planned Rhinoplasti cases
- accepted participating study
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation
Van, Tuşba, 65080
Van Yuzuncu Yil University
Van, Tuşba, 65080
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Anxiety, Pain
- Being tested
- The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain
- Keywords
- Smoking Cessation, anxiety, pain, VAS Scores, STAI Values
- Medical subject headings
- Smoking Cessation, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Relationship Between Preoperative Smoking Cessation, Anxiety, PainOther
Preoperative anxiety high score suggests stress related to surgery and anesthesia. High anxiety scores independent of post-operative pain showed smoking withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| smokers (S) | Sham comparator | Not described Receives: Other: The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain |
| non smokers (NS) | Active comparator | Not described Receives: Other: The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
assesed with STAI form
Measured: 2 hours
Secondary outcomes (1)
pain scores
independent of anxiety, assesed with VAS scores
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start17 Feb 2018
- Primary completion18 Feb 2019
- Study completion13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Esen Tekeli, Yuzuncu Yil University
- Investigators
- Arzu Esen Tekeli, MD, Principal investigator, yuzuncu yil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405219
- Sponsor's protocol ID
- 2018/05
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I do not want to share before publishing
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Smoking Cessation, Preoperative Anxiety, Postoperative Anxiety and Pain Relationship
- ClinicalTrials.gov ID
- NCT04405219
- Acronym / sponsor ID
- 2018/05
- Conditions
- Smoking Cessation, Anxiety, Pain
- Keywords
- Smoking Cessation, anxiety, pain, VAS Scores, STAI Values
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 17 Feb 2018 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 28 May 2020 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smokers (S) | Sham comparator | Other: The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain |
| non smokers (NS) | Active comparator | Other: The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I,II patients
- planned Rhinoplasti cases
- accepted participating study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Relationship Between Preoperative Smoking Cessation, Anxiety, PainPreoperative anxiety high score suggests stress related to surgery and anesthesia. High anxiety scores independent of post-operative pain showed smoking withdrawal. | Other | non smokers (NS), smokers (S) |
Primary outcome
Anxiety
Time frame: 2 hours
assesed with STAI form
1 secondary outcome
pain scores
Time frame: 2 hours
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 28 May 2020.
- Individual participant dataSharing planned: Undecided. I do not want to share before publishing
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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.
Arzu Esen Tekeli, MD principal investigator
yuzuncu yil
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain in people with Smoking Cessation and Anxiety, run by Yuzuncu Yil 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 5 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 28 May 2020. 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. Some participants in this study may receive a placebo. 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?
Anxiety (time frame: 2 hours). 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 28 May 2020.