Evaluation of Benefits of Nasal Septal Surgery on Subjective Sleep Quality, Daytime and Dream Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- The amelioration of subjective sleep quality with nasal septal surgery.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The amelioration of subjective sleep quality with nasal septal surgery.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点
研究者
Mustafa Gulec, M.D., Psych., Assist. Prof.
M.D., Psych., Assist. Prof.
Ataturk Training and Research Hospital