The Effect of Postoperative Progressive Relaxation Exercises on Pain, Anxiety, and Physiological Parameters in Emergency General Surgery Patients: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Postoperative Pain Score (SF-MPQ Total Score)
研究概览
简要总结
This randomized controlled trial investigated the effectiveness of postoperative progressive relaxation exercises (PRE) on pain, anxiety, and physiological parameters among adult patients undergoing emergency general surgery. Seventy patients were randomized to either a PRE intervention delivered at postoperative hour 6, postoperative day 1, and postoperative day 2, or to routine postoperative care. Pain (SF-MPQ), anxiety (STAI), and vital signs were measured. The trial demonstrated that PRE significantly reduced multidimensional pain and anxiety and improved heart rate, respiratory rate, and oxygen saturation. The study provides novel evidence that PRE is feasible and effective when implemented exclusively in the postoperative period among emergency surgical patients.
详细描述
This randomized, parallel-group clinical trial was conducted to evaluate the effectiveness and feasibility of postoperative progressive relaxation exercises (PRE) among patients undergoing emergency general surgery. Emergency surgical admissions provide no opportunity for preoperative preparation, and postoperative pain, anxiety, and autonomic instability are commonly intensified by acute physiological stress responses. The trial was designed to determine whether PRE, delivered exclusively after surgery, could reduce these symptoms and support early physiological recovery.
Following confirmation of postoperative stability at hour 6, eligible patients were randomly assigned in a 1:1 ratio to either the PRE intervention or routine postoperative care. The intervention consisted of standardized 30-minute sessions of progressive muscle relaxation conducted at postoperative hour 6, postoperative day 1, and postoperative day 2. Sessions followed a structured protocol including diaphragmatic breathing, sequential contraction-relaxation of major muscle groups, and a final integration phase. All sessions were delivered by a nurse trained in PRE.
Outcome assessments were conducted at prespecified time points using validated measures. Pain was evaluated with the Short-Form McGill Pain Questionnaire, anxiety with the State-Trait Anxiety Inventory, and physiological status through routine clinical monitoring of blood pressure, heart rate, respiratory rate, and oxygen saturation. Analyses examined both between-group differences and changes over time.
The study adhered to CONSORT guidelines for randomized trials and incorporated blinded outcome assessment and concealed allocation. No adverse events related to the intervention were reported, and all randomized participants completed follow-up.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessors who collected pain, anxiety, and physiological measurements were masked to group assignment throughout the study. Data analysts were also blinded by using coded datasets without group identifiers. Participants and care providers could not be masked due to the behavioral nature of the intervention, but standard postoperative care protocols were applied equally to minimize performance bias.
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
- •Adults aged 18 years or older.
- •Undergoing an emergency surgical procedure requiring postoperative hospitalization.
- •Conscious, oriented, and hemodynamically stable by postoperative hour
- •Able to communicate and follow verbal instructions.
- •No psychiatric, neurological, cognitive, or auditory impairment that would prevent participation.
- •No chronic pain disorder and not using long-term opioids, sedatives, or anxiolytics before admission.
- •Provided written informed consent.
排除标准
- •Postoperative admission to the intensive care unit (ICU).
- •Development of postoperative complications preventing participation (e.g., severe bleeding, respiratory distress, infection).
- •Inability to complete all three scheduled PRE sessions.
- •Postoperative confusion, delirium, or any condition limiting communication.
结局指标
主要结局
Change in Postoperative Pain Score (SF-MPQ Total Score)
时间窗: Postoperative hour 6 and postoperative day 2.
Postoperative pain will be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ), which includes sensory and affective descriptors, the Present Pain Intensity (PPI) index, and a Visual Analogue Scale (VAS). Total Score Range: 0 to 45. Higher scores indicate greater pain severity.
Change in State Anxiety Score (STAI-State, TX-L1)
时间窗: Postoperative hour 6 and postoperative day 2.
SSituational anxiety will be assessed using the State Anxiety Inventory (STAI-State). Score Range: 20 to 80. Higher scores indicate greater state anxiety.
次要结局
- Use of Opioid Analgesics(Postoperative hour 6, postoperative day 1, and postoperative day 2.)
- Change in Trait Anxiety Score (STAI-Trait, TX-L2)(Postoperative hour 6 and postoperative day 2.)
- Change in Systolic Blood Pressure(Postoperative hour 6, postoperative day 1, postoperative day 2.)
- Change in Diastolic Blood Pressure(Postoperative hour 6, postoperative day 1, and postoperative day 2.)
- Change in Heart Rate(Postoperative hour 6, postoperative day 1, and postoperative day 2.)
- Change in Respiratory Rate(Postoperative hour 6, postoperative day 1, and postoperative day 2.)
- Change in Oxygen Saturation (SpO₂)(Postoperative hour 6, postoperative day 1, and postoperative day 2.)
- Use of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)(Postoperative hour 6, postoperative day 1, and postoperative day 2.)
研究者
Volkan Gokmen
Asisstant Professor
Agri Ibrahim Cecen University