Effects of Nasal Septal Surgery on Sleep Quality, Daytime and Dream Anxiety
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|ClinicalTrials.gov Identifier: NCT01592123|
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : May 7, 2012
|Condition or disease||Intervention/treatment|
|Nasal Septal Deviation||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)|
|Study Type :||Observational|
|Actual Enrollment :||68 participants|
|Official Title:||Evaluation of Benefits of Nasal Septal Surgery on Subjective Sleep Quality, Daytime and Dream Anxiety|
|Study Start Date :||October 2010|
|Actual Study Completion Date :||April 2012|
|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 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592123
|Ataturk University, Yakutiye Research Hospital|
|Erzurum, Yakutiye, Turkey, 25240|
|Principal Investigator:||Mustafa Gulec, investigator||Ataturk University, Faculty of Medicine, Department of Psychiatry|