The Effect of Inhalation Aromatherapy on Pain and Anxiety Levels of The Patients Undergoing Prostate Biopsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The STAI index
研究概览
简要总结
The study included 120 male patients who would undergo a prostate biopsy. Patients were divided into 3 groups as placebo group (n = 40), Levander group (N = 40), and Frankincense group (n = 40). Aromatherapy agents were added to the nebulizer at a rate of 2%. Only saline solution was applied to the placebo group. The nebulizer was prepared and operated in the room where the prostate biopsy would be performed before the procedure. Patients were taken to the room 5 minutes before the procedure and the nebulizer was operated during the procedure. The level of anxiety was evaluated by the State Anxiety Inventory (STAI-I). After the procedure, the patient was rested and were again filled out the STAI-1 form. After that, the data of all the patients involved in the study was compared.
详细描述
The study was conducted at Mersin University Medical Faculty Hospital Urology Department and Mersin City Training and Research Hospital Urology Department. The study was designed as a placebo-controlled prospective double-blind study. Approval was obtained from the Mersin University Ethics Committee for the study (13.05.2020, 375). All patients who participated were informed about the study and received written consent. The study included 120 male patients who would undergo a prostate biopsy. Exclusion criteria were identified as; patients with pain prior to the procedure (VAS value is non-zero), any respiratory disease (lung cancer, asthma, bronchitis, chronic obstructive pulmonary disease, etc.), patients using painkillers in the last 3 hours, patients who were disturbed by the smell of used essential oils and patients with a known allergy to used essential oils with a history of contact dermatitis against cosmetic odor. Patients with these characteristics were not included in the study. During transrectal ultrasound-guided prostate biopsy, periprostatic local anesthesia was routinely administered to all patients and is routinely performed in all prostate biopsies performed in the clinic. Patients have filled out STAI-2 (trait index) forms before the procedure. The STAI clearly distinguishes between the temporary situation of state anxiety and the more general and long-term quality of trait anxiety. The STAI index has 2 subheadings, STAI-1 (state index) and STAI-2 (trait index), with 40 questions. The scores of each subscale could range from a minimum of 20 to a maximum of 80. A score of 20-31 reflected mild anxiety, 32-42 below moderate anxiety, 43-53 above moderate anxiety, 54-64 relatively severe anxiety, and 65-75 severe anxiety. Patients were grouped and randomized according to the STAI-2 (trait index) scores.
Patients were divided into 3 groups placebo group (n = 40), Levander group (N = 40), and Frankincense group (n = 40). Aromatherapy agents were added to the nebulizer at a rate of 2%. Only saline solution was applied to the placebo group. The nebulizer was prepared and operated in the room where the prostate biopsy would be performed before the procedure. Patients were taken to the room 5 minutes before the procedure and the nebulizer was operated during the procedure. The level of anxiety was evaluated by the State Anxiety Inventory (STAI-I). The STAI-1 form was used to determine the transitory emotional state and anxiety level of the participants before and after the procedure. The interrogation procedures were carried out by an assistant doctor who had no knowledge about the study. After the procedure, the patient was rested and again filled out the STAI-1 form. After that, the data of all the patients involved in the study was compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing prostate biopsy
排除标准
- •Patients with pain prior to the procedure (VAS value is non-zero),
- •Patients with respiratory disease (lung cancer, asthma, bronchitis, chronic obstructive pulmonary disease, etc.),
- •Patients using painkillers in the last 3 hours,
- •Patients who were disturbed by the smell of used essential oils
- •Patients with a known allergy to used essential oils with a history of contact dermatitis against cosmetic odor.
研究组 & 干预措施
Saline group
Only saline solution was applied to the placebo group. The nebulizer was prepared and operated in the room where the prostate biopsy would be performed before the procedure. Patients were taken to the room 5 minutes before the procedure and the nebulizer was operated on during the procedure
干预措施: Aromatherapy (Other)
Levander group
Levander oil was added to the nebulizer at a rate of 2%. The nebulizer was prepared and operated in the room where the prostate biopsy would be performed before the procedure. Patients were taken to the room 5 minutes before the procedure and the nebulizer was operated during the procedure.
干预措施: Aromatherapy (Other)
Frankincense group
Frankincense oil was added to the nebulizer at a rate of 2%. Only saline solution was applied to the placebo group. The nebulizer was prepared and operated in the room where the prostate biopsy would be performed before the procedure. Patients were taken to the room 5 minutes before the procedure and the nebulizer was operated during the procedure.
干预措施: Aromatherapy (Other)
结局指标
主要结局
The STAI index
时间窗: Immediately after the procedure.
The STAI-1 form was used to determine the transitory emotional state and anxiety level of the participants before and after the procedure. The STAI index has 2 subheadings, STAI-1 (state index) and STAI-2 (trait index), with a total of 40 questions. The scores of each subscale could range from a minimum of 20 to a maximum of 80. Higher scores are positively correlated with higher levels of anxiety. A score of 20-31 reflected mild anxiety, 32-42 below moderate anxiety, 43-53 above moderate anxiety, 54-64 relatively severe anxiety, and 65-75 severe anxiety distinguishes between the temporary situation of state anxiety and the more general and long-term quality of trait anxiety.
次要结局
未报告次要终点
研究者
Barıs Saylam
Associate Proffesor
Mersin Training and Research Hospital
