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

Tracking Information
First Submitted Date	April 30, 2012
First Posted Date	May 7, 2012
Last Update Posted Date	May 7, 2012
Study Start Date	October 2010
Primary Completion Date	Not Provided
Current Primary Outcome Measures; (submitted: May 3, 2012)	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.; 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.; 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.
Original Primary Outcome Measures	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Effects of Nasal Septal Surgery on Sleep Quality, Daytime and Dream Anxiety
Official Title	Evaluation of Benefits of Nasal Septal Surgery on Subjective Sleep Quality, Daytime and Dream Anxiety
Brief Summary	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.
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	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	Otorhinolaryngology outpatient clinic
Condition	Nasal Septal Deviation
Intervention	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 Name: 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 Name: 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 Name: 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 Name: The Van Dream Anxiety Scale (Agargun et al., 1999)
Study Groups/Cohorts	The participants with septal deviation; Interventions: Procedure: The active anterior rhinomanometry; Behavioral: The Pittsburgh Sleep Quality Index (PSQI); Behavioral: The Beck Anxiety Inventory (BAI); Behavioral: The Van Dream Anxiety Scale (VDAS)
Publications *	Baumann I. Quality of life before and after septoplasty and rhinoplasty. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2010;9:Doc06. doi: 10.3205/cto000070. Epub 2011 Apr 27.; Moore M, Eccles R. Objective evidence for the efficacy of surgical management of the deviated septum as a treatment for chronic nasal obstruction: a systematic review. Clin Otolaryngol. 2011 Apr;36(2):106-13. doi: 10.1111/j.1749-4486.2011.02279.x. Review.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: May 3, 2012)	68
Original Actual Enrollment	Same as current
Actual Study Completion Date	April 2012
Primary Completion Date	Not Provided
Eligibility Criteria	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Turkey
Removed Location Countries
Administrative Information
NCT Number	NCT01592123
Other Study ID Numbers	MG-ATA-001
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Mustafa Gulec, M.D., Psych., Assist. Prof., Ataturk Training and Research Hospital
Study Sponsor	Ataturk Training and Research Hospital
Collaborators	Not Provided
Investigators	Principal Investigator: Mustafa Gulec, investigator Ataturk University, Faculty of Medicine, Department of Psychiatry
PRS Account	Ataturk Training and Research Hospital
Verification Date	May 2012