Preoperative Psychotherapy and Its Effects on Anxiety, Hemodynamics, and Pain in Living Kidney Donors (PREPSY-KD)

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Preoperative Anxiety; Living Kidney Donation
• Intervention / Treatment: Behavioral: Preoperative Psychiatric Consultation; Other: No Intervention: Standard Preoperative Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Antalya
    • Antalya, Antalya, Turkey (Türkiye), 07000
      • Akdeniz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Preoperative Psychiatric Consultation; A brief psychiatric intervention including psychoeducation, breathing exercises, and guided imagery was provided one hour before surgery under psychiatrist supervision.
Active Comparator: 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.	Other: No Intervention: Standard Preoperative Care; Routine preoperative evaluation and intraoperative monitoring without psychiatric intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Score	Pain severity was measured using a 0-10 Visual Analog Scale (VAS), with 0 indicating no pain and 10 indicating the worst pain imaginable.	Postoperative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State Anxiety Score	Preoperative and postoperative anxiety levels measured using the Beck Anxiety Inventory (BAI; range 0-63; higher scores indicate greater anxiety).	30 minutes before surgery (preoperative), postoperative 24 hours, postoperative 48 hours
Postoperative SpO2 Levels	Postoperative oxygen saturation (SpO2; %) measured using standard pulse oximetry	Postoperative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours
Intraoperative Heart Rate	Intraoperative heart rate measured using standard monitors (beats per minute)	Pre-induction, 30 minutes after induction, and 1 hour after induction
Intraoperative SpO2 Levels	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.	Pre-induction, 30 minutes after induction, and 1 hour after induction
Intraoperative Systolic Blood Pressure	Intraoperative systolic blood pressure measured in millimeters of mercury (mmHg)	Pre-induction, 30 minutes after induction, and 1 hour after induction
Intraoperative Diastolic Blood Pressure	Intraoperative diastolic blood pressure measured in millimeters of mercury (mmHg)	Pre-induction, 30 minutes after induction, and 1 hour after induction
Total Opioid Consumption	Total opioid dose administered during and after surgery, recorded in milligrams (mg)	Intraoperative period, postoperative first 24 hours
Antiemetic Use	Administration of antiemetic agents (e.g., ondansetron), recorded as yes/no and dosage in milligrams (mg)	Intraoperative period, postoperative first 6 hours

Collaborators and Investigators

• Sponsor: Akdeniz University

Publications and helpful links

General Publications

• Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.
• Sidawy AN, Spergel LM, Besarab A, Allon M, Jennings WC, Padberg FT Jr, Murad MH, Montori VM, O'Hare AM, Calligaro KD, Macsata RA, Lumsden AB, Ascher E; Society for Vascular Surgery. The Society for Vascular Surgery: clinical practice guidelines for the surgical placement and maintenance of arteriovenous hemodialysis access. J Vasc Surg. 2008 Nov;48(5 Suppl):2S-25S. doi: 10.1016/j.jvs.2008.08.042.
• Bayrak A, Sagiroglu G, Copuroglu E. Effects of Preoperative Anxiety on Intraoperative Hemodynamics and Postoperative Pain. J Coll Physicians Surg Pak. 2019 Sep;29(9):868-873. doi: 10.29271/jcpsp.2019.09.868.
• Lv JC, Zhang LX. Prevalence and Disease Burden of Chronic Kidney Disease. Adv Exp Med Biol. 2019;1165:3-15. doi: 10.1007/978-981-13-8871-2_1.
• Li PK, Chow KM. Peritoneal dialysis patient selection: characteristics for success. Adv Chronic Kidney Dis. 2009 May;16(3):160-8. doi: 10.1053/j.ackd.2009.02.001.
• Tola YO, Chow KM, Liang W. Effects of non-pharmacological interventions on preoperative anxiety and postoperative pain in patients undergoing breast cancer surgery: A systematic review. J Clin Nurs. 2021 Dec;30(23-24):3369-3384. doi: 10.1111/jocn.15827. Epub 2021 May 3.
• Lentine KL, Kasiske BL, Levey AS, Adams PL, Alberu J, Bakr MA, Gallon L, Garvey CA, Guleria S, Li PK, Segev DL, Taler SJ, Tanabe K, Wright L, Zeier MG, Cheung M, Garg AX. KDIGO Clinical Practice Guideline on the Evaluation and Care of Living Kidney Donors. Transplantation. 2017 Aug;101(8S Suppl 1):S1-S109. doi: 10.1097/TP.0000000000001769.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative pain; Psychological support; Opioid use; Preoperative anxiety; Hemodynamic parameters; Living kidney donor; Psychiatric intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: KAEK-840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A final decision regarding sharing of individual participant data (IPD) has not yet been made. IPD sharing will be evaluated after study completion and analysis of the results. If IPD sharing is approved, anonymized datasets will be made available on a publicly accessible repository, and a link will be provided in the "Available IPD/Information" section of the record.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No