Effects of Nasal Septal Surgery on Sleep Quality, Daytime and Dream Anxiety

May 3, 2012 updated by: Mustafa Gulec, M.D., Psych., Assist. Prof., Ataturk Training and Research Hospital

Evaluation of Benefits of Nasal Septal Surgery on Subjective Sleep Quality, Daytime and Dream Anxiety

The aim of this report was to assess the frequency of poor sleep quality, daytime and dream anxiety and their response to subsequent surgical treatment for a representative group patients with nasal septum deviation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prior to the surgery, nasal airflows and airway resistances were measured employing rhinomanometry and they were also asked to fill in the Pittsburgh Sleep Quality Index (PSQI), the Beck Anxiety Inventory (BAI), and the Van Dream Anxiety Scale (VDAS). And, a postoperative assessment for the same parameters was made at two months from the day of the surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

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

  • Turkey
    • Yakutiye
      • Erzurum, Yakutiye, Turkey, 25240
        • Ataturk University, Yakutiye Research Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Otorhinolaryngology outpatient clinic

Description

Inclusion Criteria:

  • All participants, 18 to 65 years of age, had septal deviation consistent with the presenting symptoms which last at least three months and persist after a three months trial of medical management, including topical nasal steroids, topical or oral decongestants, or an oral antihistamine/decongestant combination.

Exclusion Criteria:

Patients were excluded from the study if they had nasal septal surgery performed for other reasons, such as

  • an access to nasal and sinus tumors,
  • pituitary surgery and as part of treatment for sleep apnea or with concurrent sinus surgery;
  • had rhinoplasty prior to submucous resection;
  • had acute nasal trauma;
  • had adenoid hypertrophy;
  • had uncontrolled asthma/nasal allergy;
  • had diagnosed or suspected (snoring with/without other symptoms, such as apneas referred by someone and/or somnolence) OSA;
  • had obesity (BMI ≥ 30.0 kg/m2);
  • had an unstable physical disorder;
  • had a current or lifetime history of any functional or organic mental disorder;
  • had a history of seizures;
  • had a neurological disorder that significantly affects central nervous system functions;
  • had met criteria for substance abuse or dependence in the previous 12 months, including nicotine dependence;
  • were taking medications that may cause or exacerbate sleep problems, daytime and dream anxiety; had clinical or laboratory evidence of hypothyroidism without adequate and stable replacement therapy;
  • had a history of antidepressant or sedative-hypnotic medications for any current or past complaint;
  • were pregnant or breastfeeding; or
  • were women not using effective contraception.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
The participants with septal deviation
Procedure: The active anterior rhinomanometry
In this method, the airflow through 1 nasal cavity and the pressure gradient across this nasal cavity are measured simultaneously at each breath as recommended by the committee report on the standardization of rhinomanometry. All measurements were performed under the same standard conditions. Herein, all presented airflow values are the sum of inspiratory airflow of the right and left sides of the nose at 150 pascals (Pa). And, total nasal airflow (cm3/s) and airway resistance (Pa/cm3/s) values were used for statistical analyses.
Other Names:
  • Rhino 4000M (Homoth, Hamburg, Germany)
Behavioral: The Pittsburgh Sleep Quality Index (PSQI)
PSQI was developed to measure sleep quality during the previous month and to discriminate between good and poor sleepers. The self-administered scale contains 15 multiple-choice items that inquire about frequency of sleep disturbances and subjective sleep quality and 4 write-in items that inquire about typical bedtime, wake-up time, sleep latency, and sleep duration. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range of 0-21). A PSQI global score >5 is considered to be suggestive of significant sleep disturbance.
Other Names:
  • The Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Behavioral: The Beck Anxiety Inventory (BAI)
The BAI is a 21-item self-report questionnaire that lists symptoms of anxiety. The respondent is asked to rate how much each symptom has bothered him/her in the past week. The symptoms are rated on a four-point scale, ranging from ''not at all'' (0) to ''severely'' (3). The instrument has excellent internal consistency and high test-retest reliability. The BAI has been widely used to measure severity of anxiety by self-report.
Other Names:
  • The Beck Anxiety Inventory (Beck et al., 1988)
Behavioral: The Van Dream Anxiety Scale (VDAS)
The VDAS provides the assessment of nightmare frequency and dream anxiety caused by frightening dreams during the preceding month. There are 17 self-rated questions in the scale. Twelve questions (1-4, 6, 11-17) that are tabulated in the scoring are weighted equally on a 0-4 scale. Question 5 is related to autonomic hyperactivity and consists of 12 symptoms. Each of 12 symptoms is also weighted on a 0-4 scale. Thirteen question scores are summed to yield a global VDAS score, which has a range of 0-42.
Other Names:
  • The Van Dream Anxiety Scale (Agargun et al., 1999)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The amelioration of subjective sleep quality with nasal septal surgery.
Time Frame: A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
The Pittsburgh Sleep Quality Index (PSQI) was used for the evaluations.
A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
The amelioration of daytime anxiety with nasal septal surgery.
Time Frame: A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
The Beck Anxiety Inventory (BAI) was used for the evaluations.
A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
The amelioration of dream anxiety with nasal septal surgery.
Time Frame: A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
The Van Dream Anxiety Scale (VDAS) was used for the evaluations.
A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mustafa Gulec, investigator, Ataturk University, Faculty of Medicine, Department of Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MG-ATA-001

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