Efficacy in Reducing Anxiety, Stress, and Pain Levels Through Preanesthetic Assessment and Pain Neuroscience Education in Patients Undergoing Elective Total Abdominal Hysterectomy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in Perceived Stress Scale - 14 items (PSS-14)
研究概览
简要总结
Through this quantitative, multivariate factorial experimental parallel randomized clinical trial, the investigators analyzed the effectiveness of pre-anesthetic assessment and pain neuroscience education in reducing anxiety, stress, and pain levels in patients undergoing elective total abdominal hysterectomy.
详细描述
Hysterectomy is a common surgical procedure with a low risk of major complications. However, some women experience long-lasting complications, including chronic postsurgical pain, which can have a negative impact on their quality of life.
The population will be made up of women with elective total abdominal hysterectomy scheduled surgery at the University Hospital of Puebla BUAP, in the city of Puebla, Mexico.
Then the investigators will carry out an pre-anesthetic evaluation will be carried out and an pain neuroscience education session will be carried out.
Once patients are ready for surgery, the investigators will carry out an invasive monitoring will be performed in the post-anesthesia care unit. The blood pressure of the participants will be monitored non-invasively. They will also be monitored with electrocardiogram and pulse oximetry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors were blinded to group allocation. Care providers and the investigator delivering the intervention were not blinded due to the nature of the intervention. Data analysts remained blinded during statistical analysis.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Anesthesia Physical Classification System: I, II or III according to the classification of the American Society of Anesthesiology.
- •Acceptance of informed consent
- •Basic literacy skills sufficient to understand and complete study questionnaires.
排除标准
- •Inability to understand study procedures or complete questionnaires.
- •Inflammatory rheumatic disease
- •Major neurological or psychiatric disease, Intellectual disability (mental retardation) or learning disorders at the premorbid level or severe language comprehension problems.
研究组 & 干预措施
Experimental: Pain Neuroscience Education plus Pre-anesthetic Assessment
Participants assigned to this arm received one face-to-face Pain Neuroscience Education (PNE) session (approximately 35 minutes) in addition to the standard pre-anesthetic assessment. PNE consisted of an educational intervention focused on the neurobiology and neurophysiology of pain and pain processing by the nervous system.
干预措施: Pain Neuroscience Education (Other)
Experimental: Pain Neuroscience Education plus Pre-anesthetic Assessment
Participants assigned to this arm received one face-to-face Pain Neuroscience Education (PNE) session (approximately 35 minutes) in addition to the standard pre-anesthetic assessment. PNE consisted of an educational intervention focused on the neurobiology and neurophysiology of pain and pain processing by the nervous system.
干预措施: Usual care (Other)
Pre-anesthetic Assessment (Usual Care)
Participants assigned to this arm received standard pre-anesthetic assessment (usual care), which included evaluation of physical condition, medical and surgical history, and laboratory tests, in order to establish surgical risk and define the anesthetic plan according to the surgical procedure.
干预措施: Usual care (Other)
结局指标
主要结局
Change in Perceived Stress Scale - 14 items (PSS-14)
时间窗: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
Perceived stress was assessed using the 14-item Perceived Stress Scale (PSS-14). Each item is rated on a 5-point Likert scale (0-4), yielding a total score ranging from 0 to 56, with higher scores indicating greater perceived stress.
Change in Visual Analog Scale-Pain (EVA)
时间窗: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
Pain intensity at rest was assessed using a 10-cm visual analog scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Change in Perceived Stress Scale - 14 items (PSS-14)
时间窗: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
Perceived stress was assessed using the 14-item Perceived Stress Scale (PSS-14). Each item is rated on a 5-point Likert scale (0-4), yielding a total score ranging from 0 to 56, with higher scores indicating greater perceived stress.
Change in Beck Anxiety Inventory (BAI)
时间窗: Baseline (preoperative), 1 hour postoperative, and 8 hours postoperative
Anxiety symptoms were assessed using the Beck Anxiety Inventory (BAI), a 21-item self-reported questionnaire. Each item is scored from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate greater anxiety severity.
次要结局
未报告次要终点