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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mustafa Gulec, M.D., Psych., Assist. Prof., Ataturk Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01592123
First received: April 30, 2012
Last updated: May 3, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
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
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Benefits of Nasal Septal Surgery on Subjective Sleep Quality, Daytime and Dream Anxiety

Resource links provided by NLM:


Further study details as provided by Ataturk Training and Research Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    The Van Dream Anxiety Scale (VDAS) was used for the evaluations.


Enrollment: 68
Study Start Date: October 2010
Study Completion Date: April 2012
Groups/Cohorts Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Otorhinolaryngology outpatient clinic

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01592123

Locations
Turkey
Ataturk University, Yakutiye Research Hospital
Erzurum, Yakutiye, Turkey, 25240
Sponsors and Collaborators
Ataturk Training and Research Hospital
Investigators
Principal Investigator: Mustafa Gulec, investigator Ataturk University, Faculty of Medicine, Department of Psychiatry
  More Information

Publications:
Responsible Party: Mustafa Gulec, M.D., Psych., Assist. Prof., M.D., Psych., Assist. Prof., Ataturk Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01592123     History of Changes
Other Study ID Numbers: MG-ATA-001
Study First Received: April 30, 2012
Last Updated: May 3, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by Ataturk Training and Research Hospital:
anxiety
septal surgery
septum deviation
sleep

Additional relevant MeSH terms:
Anxiety Disorders
Nose Deformities, Acquired
Mental Disorders
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 26, 2014