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

NCT07261917 | Completed

• 1 other identifier: KAEK-840
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Living Kidney Donation; Preoperative Anxiety

Keywords

Living kidney donor; Psychiatric intervention; Preoperative anxiety; Postoperative pain; Hemodynamic parameters; Opioid use; Psychological support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

Intervention Group: Preoperative Psychiatric Consultation

EXPERIMENTAL

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

Control Group: Standard Preoperative Care

ACTIVE COMPARATOR

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

Interventions

Preoperative Psychiatric Consultation BEHAVIORAL

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

Intervention Group: Preoperative Psychiatric Consultation

No Intervention: Standard Preoperative Care OTHER

Routine preoperative evaluation and intraoperative monitoring without psychiatric intervention.

Control Group: Standard Preoperative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Hospital

Antalya, Antalya, 07000, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 19000589 BACKGROUND

• 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.

  PMID: 19393965 BACKGROUND

• 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.

  PMID: 31399958 BACKGROUND

• 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.

  PMID: 33942405 BACKGROUND

• 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.

  PMID: 31455484 BACKGROUND

• 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.

  PMID: 28742762 BACKGROUND

• 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.

  PMID: 23732715 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcomes assessors (VAS scores) were blinded to the group allocation. Participants, care providers, and investigators were aware of the assignments
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The psychological education and interventions applied to the intervention group were supported by practical and detailed training sessions conducted by a psychiatrist for the anesthesiologist, along with supervision. One hour before the operation, patients underwent a supervised interview lasting approximately 15 minutes under the psychiatrist's supervision upon hospital admission. This interview consisted of history-taking (3-5 minutes), psychoeducation (3-5 minutes), diaphragmatic breathing exercises (1-3 minutes), and guided imagery (3-5 minutes). During the interview, the patient engaged in a conversation, was provided with information about the operation, received standardized psychoeducation about anxiety in collaboration with the psychiatrist, and was guided through anxiety-reducing techniques such as diaphragmatic breathing exercises and guided imagery.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 3, 2025
• Study Start: November 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

TU (1)