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

Completed

• Conditions: Nasal Septal Deviation
• Interventions: 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)

• Registration Number: NCT01592123
• Lead Sponsor: Ataturk Training and Research Hospital

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.

Study Timeline

• Study Start: 2010-10
• Study Completion: 2012-04
• Study First Submitted: 2012-04-30
• Status Verified: 2012-05
• Study First Submitted QC: 2012-05-03
• Last Update Submitted: 2012-05-03
• Study First Posted: 2012-05-07
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The participants with septal deviation	The active anterior rhinomanometry	-
The participants with septal deviation	The Pittsburgh Sleep Quality Index (PSQI)	-
The participants with septal deviation	The Beck Anxiety Inventory (BAI)	-
The participants with septal deviation	The Van Dream Anxiety Scale (VDAS)	-

Primary Outcome Measures

Name	Time	Method
The amelioration of subjective sleep quality with nasal septal surgery.	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.	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.	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.

Trial Locations

Locations (1)

Ataturk University, Yakutiye Research Hospital; 🇹🇷 Erzurum, Yakutiye, Turkey