Clinical trial NCT01592123: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Septal Deviation
Keywords: anxiety
septal surgery
septum deviation
sleep
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Otorhinolaryngology outpatient clinic

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.

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.

Primary outcomes:
measure: The amelioration of subjective sleep quality with nasal septal surgery.
timeFrame: A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
measure: The amelioration of daytime anxiety with nasal septal surgery.
timeFrame: A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
measure: The amelioration of dream anxiety with nasal septal surgery.
timeFrame: A postoperative assessment for the aforementioned parameter was made at two months from the day of the surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University, Yakutiye Research Hospital
state: Yakutiye
Study officials:
affiliation: Ataturk University, Faculty of Medicine, Department of Psychiatry
name: Mustafa Gulec, investigator
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.