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

NCT ID: NCT07261917

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-11-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Living Kidney Donation Preoperative Anxiety Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Only the outcomes assessors (VAS scores) were blinded to the group allocation. Participants, care providers, and investigators were aware of the assignments

Study Groups

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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.

Group Type EXPERIMENTAL

Preoperative Psychiatric Consultation

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

No Intervention: Standard Preoperative Care

Intervention Type OTHER

Routine preoperative evaluation and intraoperative monitoring without psychiatric intervention.

Interventions

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Preoperative Psychiatric Consultation

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

Intervention Type BEHAVIORAL

No Intervention: Standard Preoperative Care

Routine preoperative evaluation and intraoperative monitoring without psychiatric intervention.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Bora Dinc

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Akdeniz University Hospital

Antalya, Antalya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 19000589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19393965 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31399958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33942405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31455484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28742762 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23732715 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol

View Document

Other Identifiers

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KAEK-840

Identifier Type: -

Identifier Source: org_study_id

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