Trials / Completed
CompletedNCT01592123
Effects of Nasal Septal Surgery on Sleep Quality, Daytime and Dream Anxiety
Evaluation of Benefits of Nasal Septal Surgery on Subjective Sleep Quality, Daytime and Dream Anxiety
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 68 (actual)
- Sponsor
- Ataturk Training and Research Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Timeline
- Start date
- 2010-10-01
- Completion
- 2012-04-01
- First posted
- 2012-05-07
- Last updated
- 2012-05-07
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT01592123. Inclusion in this directory is not an endorsement.