The Effect of Pain Education Given to Patients Before Total Knee and Hip Replacement Surgery on Anxiety, Pain and Analgesic Use: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Is there a difference in postoperative pain levels between the intervention group, which received preoperative pain education, and the control group, which did not receive preoperative pain education?"
研究概览
简要总结
This randomized controlled trial evaluates whether a standardized preoperative pain education session delivered by a nurse reduces postoperative pain intensity and surgical anxiety among adult elective orthopedic surgery patients compared with usual care.
Primary outcome is postoperative pain at 24 hours. Secondary outcomes include anxiety, analgesic consumption, patient satisfaction, and length of stay
详细描述
Adult patients scheduled for elective orthopedic surgery will be randomized (1:1) to receive either (a) a structured 20-30-minute preoperative pain education session plus booklet and video, or (b) usual care alone. Pain intensity measured with NRS at 1, 6,12, 24, 48h postop; analgesics recorded Day 0, 1, 2; preop anxiety measured with Surgical Anxiety Scale in both groups. Intention-to-treat analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 18 years of age or older,
- •Providing voluntary informed consent to participate in the study,
- •Scheduled to undergo elective knee or hip joint replacement (arthroplasty) surgery,
- •Having no communication barriers,
- •Having no history of alcohol or substance dependence,
- •Having no concurrent diagnosis of malignant disease and not receiving cancer treatment,
- •Not using opioid medications regularly in the preoperative period,
- •Having an ASA score of III or below,
- •Having no cognitive impairment that would affect the ability to comprehend the provided education,
- •Having no diagnosed neurological or psychiatric disorder and not using medications related to such conditions.
排除标准
- •- Patients who do not meet the specified inclusion criteria will not be included in the study.
- •Elimination criteria:
- •Indication for postoperative intensive care,
- •Development of major complications after surgery, such as massive bleeding or pulmonary embolism,
- •Requesting to withdraw from the study at any stage,
- •Use of a patient-controlled analgesia device postoperatively
研究组 & 干预措施
Experimental Group
Pain Education
干预措施: Pain education (Other)
Control Group
No education no video
结局指标
主要结局
Is there a difference in postoperative pain levels between the intervention group, which received preoperative pain education, and the control group, which did not receive preoperative pain education?"
时间窗: Pain assessment was evaluated at 1, 6, 12, 24, and 48 hours postoperatively.
The intervention group received a preoperative pain education booklet and watched a pain education video, while the control group did not receive any educational intervention. Both groups were asked to rate their pain on the Numerical Rating Scale (NRS) from 0 to 10 at 1, 6, 12, 24, and 48 hours postoperatively, where 0 indicated no pain (a good score) and 10 indicated the worst possible pain (a poor score). Since pain is subjective, the patients' self-reported scores were recorded as provided. The differences between the two groups were subsequently analyzed.
Does preoperative pain education reduce preoperative anxiety?
时间窗: Baseline (preoperatively, before surgery) and postoperatively at 1 hour, 6 hours, 12 hours, 24 hours, and 48 hours after surgery.
This study aims to investigate whether there is a significant difference in preoperative anxiety levels between patients who received preoperative pain education (intervention group) and those who did not (control group). The Surgical Anxiety Questionnaire - (SAQ) was used to assess patients anxiety. In this 17-item scale, the individual is asked to rate how anxious or worried they are for each item on a five-point likert type scale:"Not at all", "A little bit" ''Moderately'' ''Very'' and ''Extremely''. The answers given to each item are scored between 0-4. There is no cut-off value, and as the score increases, the individual anxiety is interpreted as higher. Cronbachs alpha coefficient was reported to be 0.91 in the original version of the scale. The Turkish version of the surgical anxiety questionnaire consisted of a 3-factor structure, and the Cronbach alpha value was 0.93. As a result, the Turkish form of the scale contains 15 items.
次要结局
未报告次要终点
研究者
Ceren Ustun
Hemşire Ceren Üstün
Yeditepe University