Preoperative Psychotherapy and Its Effects on Anxiety, Hemodynamics, and Pain in Living Kidney Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score
研究概览
简要总结
Chronic kidney failure is a condition in which the kidneys progressively lose their ability to filter waste, maintain fluid and electrolyte balance, and support essential physiological functions. When kidney function (glomerular filtration rate, GFR) decreases below 15 ml/min/1.73 m^2, the condition is classified as end-stage renal disease (ESRD), and treatment such as dialysis or kidney transplantation becomes necessary.
Kidney transplantation improves quality of life and survival for individuals with ESRD. However, the transplantation process is physically and psychologically stressful for both recipients and living kidney donors. Preoperative anxiety in donors may adversely affect the surgical process, pain perception, recovery, and overall clinical outcomes.
Psychiatric support prior to surgery may help reduce anxiety and improve physiological stability, pain control, and patient satisfaction during the perioperative period. Such support may also reduce the requirement for analgesic medications and prevent related complications.
This study aims to evaluate the effects of preoperative psychiatric consultation on perioperative anxiety levels, intraoperative hemodynamic parameters, postoperative pain scores, and complication rates in living kidney donors.
详细描述
Chronic kidney failure is a condition in which the kidneys progressively lose their ability to maintain fluid and electrolyte balance and perform essential endocrine and metabolic functions. This deterioration advances irreversibly due to various underlying diseases. A decrease in GFR below 60 ml/min/1.73 m^2 for more than three months indicates structural and functional abnormalities in the kidneys. When the GFR falls below 15 ml/min/1.73 m^2, the condition is defined as ESRD.
Renal replacement therapy becomes necessary when ESRD develops. Treatment options include lifestyle modifications, medical therapy, hemodialysis, peritoneal dialysis, and kidney transplantation.
Kidney transplantation is an effective treatment modality for patients with ESRD, improving quality of life, supporting long-term survival, and eliminating the need for dialysis. However, this process requires not only physical recovery but also psychological adaptation, involving a prolonged and demanding course.
Kidney transplantation represents a significant source of psychological stress for both donors and recipients. The psychological stress experienced by donors, particularly during the preoperative period, may influence the surgical process and the postoperative recovery period. Elevated preoperative anxiety levels may reduce donor adaptation to the surgical process and adversely affect both psychological and physiological recovery. Psychiatric support, education, and effective anxiety management throughout the surgical process play a critical role in mitigating these negative effects.
High levels of preoperative anxiety may alter pain perception, prolong recovery, and increase the risk of complications. Therefore, reducing preoperative anxiety through psychiatric interventions is essential for helping participants cope with surgical stress and minimizing negative psychological and physiological impacts. Numerous studies have shown that managing anxiety with preoperative psychological support contributes to more stable intraoperative hemodynamic parameters and improved postoperative pain control.
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
- Single (Outcomes Assessor)
盲法说明
Only the outcomes assessors (VAS scores) were blinded to the group allocation. Participants, care providers, and investigators were aware of the assignments
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •American Society of Anesthesiologists (ASA) physical status Class I-II
- •Voluntary participation in the study
排除标准
- •Diagnosed diabetes mellitus (DM)
- •Development of postoperative delirium
- •Previously diagnosed psychiatric disorder or current use of psychiatric medications
- •History of analgesic drug use within the last one month
- •Diagnosed neurological disorder
- •Diagnosed musculoskeletal disorder
- •Chronic pain or receiving chronic pain treatment
- •Recent severe psychological trauma or relevant psychosocial stressors
研究组 & 干预措施
Intervention Group: Preoperative Psychiatric Consultation
Participants in this group received structured preoperative psychiatric consultation. The intervention consisted of a supervised 15-minute interview conducted one hour before surgery under psychiatrist oversight. The session included history-taking (3-5 minutes), standardized psychoeducation (3-5 minutes), diaphragmatic breathing exercises (1-3 minutes), and guided imagery (3-5 minutes). Psychiatric education and anxiety-reducing techniques were delivered through a standardized protocol supported by training sessions provided to the anesthesiologist.
干预措施: Preoperative Psychiatric Consultation (Behavioral)
Control Group: Standard Preoperative Care
Participants in this group received standard preoperative care without psychiatric intervention. Twenty minutes before anesthesia induction, the Beck Anxiety Inventory was administered. Preoperative vital signs, including systolic and diastolic blood pressure, heart rate, and oxygen saturation (SpO2), were recorded in the ward. Intraoperative vital signs were documented before induction, at the 30th minute, and at the 1st hour. During emergence from anesthesia, administered antiemetic and analgesic medications (e.g., paracetamol, tramadol) were documented.
干预措施: No Intervention: Standard Preoperative Care (Other)
结局指标
主要结局
Postoperative Pain Score
时间窗: Postoperative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours
Pain severity was measured using a 0-10 Visual Analog Scale (VAS), with 0 indicating no pain and 10 indicating the worst pain imaginable.
次要结局
- State Anxiety Score(30 minutes before surgery (preoperative), postoperative 24 hours, postoperative 48 hours)
- Postoperative SpO2 Levels(Postoperative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours)
- Intraoperative Heart Rate(Pre-induction, 30 minutes after induction, and 1 hour after induction)
- Intraoperative SpO2 Levels(Pre-induction, 30 minutes after induction, and 1 hour after induction)
- Intraoperative Systolic Blood Pressure(Pre-induction, 30 minutes after induction, and 1 hour after induction)
- Intraoperative Diastolic Blood Pressure(Pre-induction, 30 minutes after induction, and 1 hour after induction)
- Total Opioid Consumption(Intraoperative period, postoperative first 24 hours)
- Antiemetic Use(Intraoperative period, postoperative first 6 hours)
研究者
Bora Dinc
Associate Professor
Akdeniz University