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Living Kidney DonationPREPSY-KDNCT07261917

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

A study testing Preoperative Psychiatric Consultation in people with Living Kidney Donation and Preoperative Anxiety, run by Akdeniz University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Preoperative Psychiatric Consultation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2023to 1 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Akdeniz University Hospital

    Antalya, Antalya, 07000

Other trials in Turkey (Türkiye)

About this study

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.

Read more

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.

Read the 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.

Being tested
Preoperative Psychiatric Consultation, No Intervention: Standard Preoperative Care
Keywords
Living kidney donor, Psychiatric intervention, Preoperative anxiety, Postoperative pain, Hemodynamic parameters, Opioid use, Psychological support
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative Psychiatric ConsultationBehavioural

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

  • No Intervention: Standard Preoperative CareOther

    Routine preoperative evaluation and intraoperative monitoring without psychiatric intervention.

Study groups in NCT07261917
Study groupRoleWhat they receive
Intervention Group: Preoperative Psychiatric ConsultationExperimentalParticipants 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.
Receives: Behavioral: Preoperative Psychiatric Consultation
Control Group: Standard Preoperative CareActive comparatorParticipants 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.
Receives: Other: No Intervention: Standard Preoperative Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (8)
  1. State Anxiety Score

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

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

  2. Postoperative SpO2 Levels

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

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

  3. Intraoperative Heart Rate

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

    Measured: Pre-induction, 30 minutes after induction, and 1 hour after induction

  4. 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.

    Measured: Pre-induction, 30 minutes after induction, and 1 hour after induction

  5. Intraoperative Systolic Blood Pressure

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

    Measured: Pre-induction, 30 minutes after induction, and 1 hour after induction

  6. Intraoperative Diastolic Blood Pressure

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

    Measured: Pre-induction, 30 minutes after induction, and 1 hour after induction

  7. Total Opioid Consumption

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

    Measured: Intraoperative period, postoperative first 24 hours

  8. Antiemetic Use

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

    Measured: Intraoperative period, postoperative first 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start1 Nov 2023
  3. Primary completion1 Oct 2024
  4. Study completion1 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07261917
Sponsor's protocol ID
KAEK-840
Acronym
PREPSY-KD
Status last verified
Nov 2025
First submitted
17 Nov 2025
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Publications

  • 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.

    PubMed 19000589
  • 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.

    PubMed 19393965
  • 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.

    PubMed 31399958
  • 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.

    PubMed 33942405
  • 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.

    PubMed 31455484
  • 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.

    PubMed 28742762
  • 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.

    PubMed 23732715
  • Demirtas A, Dinc B, Erdogan A, Aycan IO, Hadimioglu N, Temel H. Brief preoperative psychological support and postoperative pain and anxiety in living kidney donors: A randomized controlled trial. Gen Hosp Psychiatry. 2026 Oct 6;103:137-143. doi: 10.1016/j.genhosppsych.2026.10.001. Online ahead of print.

    PubMed 42854363

Questions about this trial

What is this clinical trial studying?

A study testing Preoperative Psychiatric Consultation in people with Living Kidney Donation and Preoperative Anxiety, run by Akdeniz University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Score (time frame: Postoperative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07261917, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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