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Completed

NCT Number: NCT07261917

Preoperative Psychotherapy and Its Effects on Anxiety, Hemodynamics, and Pain in Living Kidney Donors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University Hospital

Antalya, 07000, Turkey (Türkiye)

About this study

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.

Considering the influence of surgical stress on the inflammatory response in kidney donors, further investigation is required to understand how psychiatric interventions affect these parameters. Psychiatric support also plays an important role in reducing opioid requirements for pain management, minimizing opioid-related side effects, preventing postoperative complications, and enhancing overall patient satisfaction.

This study aims to examine the effects of preoperative anxiety and anxiety-reducing interventions on intraoperative and postoperative hemodynamic parameters, postoperative pain scores, and postoperative complications in living kidney donors.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • American Society of Anesthesiologists (ASA) physical status Class I-II
  • Voluntary participation in the study

Exclusion criteria

  • 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

Treatment and study plan

Preoperative Psychiatric Consultation

Behavioral

A brief psychiatric intervention including psychoeducation, breathing exercises, and guided imagery was provided one hour before surgery under psychiatrist supervision.

No Intervention: Standard Preoperative Care

Other

Routine preoperative evaluation and intraoperative monitoring without psychiatric intervention.

Primary outcomes

  1. Postoperative Pain Score

    Time frame: 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.

Secondary outcomes

  1. State Anxiety Score

    Time frame: 30 minutes before surgery (preoperative), postoperative 24 hours, postoperative 48 hours

    Preoperative and postoperative anxiety levels measured using the Beck Anxiety Inventory (BAI; range 0-63; higher scores indicate greater anxiety).

  2. Postoperative SpO2 Levels

    Time frame: Postoperative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours

    Postoperative oxygen saturation (SpO2; %) measured using standard pulse oximetry

  3. Intraoperative Heart Rate

    Time frame: Pre-induction, 30 minutes after induction, and 1 hour after induction

    Intraoperative heart rate measured using standard monitors (beats per minute)

  4. Intraoperative SpO2 Levels

    Time frame: Pre-induction, 30 minutes after induction, and 1 hour after induction

    SpO2 was continuously monitored using standard devices during the intraoperative period at pre-induction, 30 minutes, and 1 hour, and also recorded periodically during the first 48 hours postoperatively.

  5. Intraoperative Systolic Blood Pressure

    Time frame: Pre-induction, 30 minutes after induction, and 1 hour after induction

    Intraoperative systolic blood pressure measured in millimeters of mercury (mmHg)

  6. Intraoperative Diastolic Blood Pressure

    Time frame: Pre-induction, 30 minutes after induction, and 1 hour after induction

    Intraoperative diastolic blood pressure measured in millimeters of mercury (mmHg)

  7. Total Opioid Consumption

    Time frame: Intraoperative period, postoperative first 24 hours

    Total opioid dose administered during and after surgery, recorded in milligrams (mg)

  8. Antiemetic Use

    Time frame: Intraoperative period, postoperative first 6 hours

    Administration of antiemetic agents (e.g., ondansetron), recorded as yes/no and dosage in milligrams (mg)

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Acronym: PREPSY-KD

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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