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

NCT01592123 | Completed

• 1 other identifier: MG-ATA-001
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Septal Deviation

Keywords

anxiety; septal surgery; septum deviation; sleep

Outcome Measures

Primary Outcomes (3)

• The amelioration of subjective sleep quality with nasal septal 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.

  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.

  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.

Study Arms (1)

The participants with 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)

Interventions

The active anterior rhinomanometry PROCEDURE

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.

Also known as: Rhino 4000M (Homoth, Hamburg, Germany)

The participants with septal deviation

The Pittsburgh Sleep Quality Index (PSQI) BEHAVIORAL

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.

Also known as: The Pittsburgh Sleep Quality Index (Buysse et al., 1989)

The participants with septal deviation

The Beck Anxiety Inventory (BAI) BEHAVIORAL

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.

Also known as: The Beck Anxiety Inventory (Beck et al., 1988)

The participants with septal deviation

The Van Dream Anxiety Scale (VDAS) BEHAVIORAL

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.

Also known as: The Van Dream Anxiety Scale (Agargun et al., 1999)

The participants with septal deviation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Otorhinolaryngology outpatient clinic

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ataturk Training and Research Hospital: lead

Study Sites (1)

Ataturk University, Yakutiye Research Hospital

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 22073110 BACKGROUND

• 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.

  PMID: 21332671 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Mustafa Gulec, investigator

  Ataturk University, Faculty of Medicine, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Psych., Assist. Prof.

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 7, 2012
• Study Start: October 1, 2010
• Study Completion: April 1, 2012
• Last Updated: May 7, 2012

Record last verified: 2012-05

Locations

TU (1)