Preoperative Psychotherapy and Its Effects on Anxiety, Hemodynamics, and Pain in Living Kidney Donors
Phase: NA
Conditions: Living Kidney Donation, Preoperative Anxiety, Postoperative Pain
Sponsor: Akdeniz University

Study Protocol 
Preoperative Psychotherapy and Its Effects on Anxiety, Hemodynamics, and Pain in Living 
Kidney Donors (PREPSY-KD) 
Protocol Version: 1.0 
Protocol Date: November 2023 
Organization’s Protocol ID: KAEK-840 
 
1. Background and Rationale 
Living kidney donation is an essential treatment modality for end-stage renal disease (ESRD). 
Donor nephrectomy, while performed in healthy individuals, is associated with significant 
psychological stress due to hospitalization, surgical anticipation, anesthesia concerns, and 
uncertainty regarding recovery. Preoperative anxiety has been shown to negatively affect 
postoperative pain, hemodynamic stability, anesthetic requirements, and overall recovery. 
Psychotherapeutic interventions such as psychoeducation, guided imagery, and diaphragmatic 
breathing exercises have demonstrated benefits in reducing perioperative anxiety and improving 
physiological parameters. However, there is limited prospective evidence evaluating the effect 
of structured preoperative psychiatric consultations on anxiety, hemodynamic responses, and 
postoperative pain in living kidney donors. 
This study aims to assess whether a brief standardized psychiatric consultation administered 
before donor nephrectomy affects perioperative anxiety levels, intraoperative hemodynamics, 
and postoperative pain outcomes. 
 
2. Study Objectives 
Primary Objective 
• 
To evaluate the effect of preoperative psychiatric consultation on postoperative pain 
scores measured via the Visual Analog Scale (VAS) at predefined postoperative time 
points. 
Secondary Objectives 
• 
To compare preoperative and postoperative anxiety levels between intervention and 
control groups using the Beck Anxiety Inventory (BAI). 
• 
To compare intraoperative hemodynamic parameters (heart rate, systolic and diastolic 
blood pressure, SpO₂) between groups. 
• 
To evaluate postoperative oxygen saturation trends. 
• 
To assess postoperative opioid consumption and antiemetic requirements. 
 
3. Study Design 
• 
Study Type: Interventional 

• 
Design: Prospective, randomized, parallel-assignment clinical trial 
• 
Number of Arms: 2 (Intervention vs. Standard Care) 
• 
Masking: Single-blind (Outcomes Assessor) 
• 
Allocation: Randomized 
• 
Primary Purpose: Supportive Care 
• 
Study Duration: November 2023 – November 2024 
Randomization was performed via sealed envelopes during preoperative evaluation. Outcome 
assessors evaluating VAS scores were blinded to group allocation. 
 
4. Study Population 
Inclusion Criteria 
• 
Age ≥ 18 years 
• 
ASA physical status I–II 
• 
Voluntary participation with signed informed consent 
• 
Living kidney donor scheduled for elective donor nephrectomy 
Exclusion Criteria 
• 
Diabetes mellitus diagnosis 
• 
Development of postoperative delirium 
• 
Known psychiatric illness or psychiatric medication use 
• 
Neurological or musculoskeletal disorders 
• 
Chronic pain or chronic pain treatment 
• 
Recent significant psychological trauma 
• 
Analgesic drug use within the last month 
 
5. Interventions 
Intervention Group: Preoperative Psychiatric Consultation 
Participants received a standardized 15-minute psychiatric session one hour before surgery 
under psychiatrist supervision, including: 
• 
History-taking (3–5 minutes) 
• 
Psychoeducation regarding anxiety and surgical preparation (3–5 minutes) 
• 
Diaphragmatic breathing exercises (1–3 minutes) 
• 
Guided imagery techniques (3–5 minutes) 

The intervention was delivered by an anesthesiologist trained by a psychiatrist through 
structured educational sessions. 
Control Group: Standard Preoperative Care 
Participants received routine preoperative evaluation. No psychiatric intervention was 
performed. 
 
6. Outcome Measures 
Primary Outcome 
• 
Postoperative Pain Score (VAS 0–10) 
Time Frame: Postoperative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours, and 48 
hours. 
Secondary Outcomes 
1. State Anxiety Score (Beck Anxiety Inventory, 0–63) 
Time Frame: 30 minutes preoperatively, postoperative 24 hours, postoperative 48 hours. 
2. Postoperative SpO₂ Levels (%) 
Time Frame: Postoperative 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours. 
3. Intraoperative Heart Rate (beats/min) 
Time Frame: Pre-induction, 30 minutes after induction, 1 hour after induction. 
4. Intraoperative SpO₂ Levels (%) 
Time Frame: Pre-induction, 30 minutes after induction, 1 hour after induction. 
5. Intraoperative Systolic Blood Pressure (mmHg) 
Time Frame: Pre-induction, 30 minutes after induction, 1 hour after induction. 
6. Intraoperative Diastolic Blood Pressure (mmHg) 
Time Frame: Pre-induction, 30 minutes after induction, 1 hour after induction. 
7. Total Opioid Consumption (mg) 
Time Frame: Intraoperative period and postoperative first 24 hours. 
8. Antiemetic Use (Yes/No, mg) 
Time Frame: Intraoperative period and postoperative first 6 hours. 
 
7. Data Collection Procedures 
Data will be collected at standardized time points by trained staff members. Hemodynamic 
parameters will be retrieved from anesthesia monitoring records. Pain scores will be evaluated 
using a 10 cm Visual Analog Scale. Anxiety assessments will be performed by a blinded 
outcomes assessor. 
 
8. Statistical Analysis Plan 

• 
Categorical variables: χ² or Fisher’s exact test 
• 
Continuous variables with normal distribution: Independent samples t-test 
• 
Non-normal distribution: Mann–Whitney U test 
• 
Repeated measurements: Repeated Measures ANOVA or Friedman test 
• 
Correlations: Pearson or Spearman coefficients 
• 
Significance threshold: p < 0.05 
• 
Software: SPSS 15.0 version 
All analyses will be performed per-protocol. 
 
9. Ethical Considerations 
• 
Ethics Committee Approval: Akdeniz University Clinical Research Ethics Committee 
Approval Number: 2023-KAEK-20 / 840 
• 
Board Status: Approved 
• 
Participation is voluntary; written informed consent obtained from all donors. 
• 
No investigational drug or device used. 
• 
Risks are minimal and limited to standard perioperative care. 
 
10. Study Timeline 
• 
Start of enrollment: November 1, 2023 
• 
Primary completion: October 1, 2024 
• 
Study completion: November 1, 2024 
 
11. Data Management and Monitoring 
A formal Data Monitoring Committee is not required due to minimal-risk behavioral intervention 
and absence of investigational medicinal products. 
All data will be anonymized and stored securely following institutional data protection 
guidelines. 
 
12. Publication Plan 
Findings will be submitted to peer-reviewed anesthesiology and transplant journals and may be 
presented at national and international conferences. 
 

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Principal Investigator: 
Dr. Ali Demirtaş 
Akdeniz University, Department of Anesthesiology and Reanimation