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Not yet recruitingNCT07873008Relaxation-RCTUpdated Oct 14, 2026

Relaxation Exercise Interventions for Individuals Who Have Undergone Urinary Tract Stone Surgery

An interventional study of Benson Relaxation Exercise Group and Jacobson Relaxation Exercise Group in Urinary Tract Stone Surgery, Relaxation Exercise and Anxiety, sponsored by Ondokuz Mayıs University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Treatment

Updated Oct 14, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This randomized controlled trial aims to evaluate the effects of the Benson relaxation exercise and the Jacobson relaxation exercise-administered to individuals undergoing urinary tract stone surgery-on pain, vital signs (blood pressure, pulse, respiratory rate, oxygen saturation, and body temperature), and anxiety levels. Postoperative pain and anxiety are common issues that can negatively affect vital signs. Non-pharmacological interventions, such as relaxation exercises, may help reduce these adverse effects.

Participants will be randomly assigned to one of three groups: the Benson relaxation exercise group, the Jacobson relaxation exercise group, or the control group receiving routine postoperative care. Relaxation exercises will be performed two times a day for 15 minutes each, provided the individual's general condition is stable. Outcomes such as pain, anxiety, and vital signs will be measured at baseline (pre-test), on postoperative day 0, and on postoperative day 1 after each session. The findings of this study are expected to provide evidence regarding the effectiveness of relaxation exercises as supportive nursing interventions in the postoperative care of patients undergoing urinary tract stone surgery.

Read the detailed description

Urinary tract stone disease is one of the most common urological conditions worldwide and often requires surgical intervention. Following urinary tract stone surgery, patients may experience pain, anxiety, and changes in quality of life; these factors can negatively impact the recovery process and patient comfort. In managing these issues arising from the surgical process, the use of complementary and non-pharmacological interventions, in addition to pharmacological methods, is becoming increasingly important. The Benson Relaxation Exercise (BRE), developed by Benson, has been reported to be effective in reducing pain levels in patients who have undergone surgical procedures. Similarly, the Jacobson Progressive Relaxation Exercise (JPRE), developed by Jacobson, has been shown to be effective in improving stress, anxiety, pain, and certain physiological parameters.

In this study, the effects of BGE and JPGE-administered to individuals who have undergone urinary tract stone surgery-on pain, vital signs (blood pressure, pulse, respiratory rate, oxygen saturation, and body temperature), and anxiety levels will be examined. As part of the study, the individual effects of both relaxation exercises will be evaluated, and the levels of effectiveness of the methods will be compared with one another.

This study will be conducted as a single-blind, three-arm randomized controlled trial to evaluate the effects of BGE and JPGE on pain, vital signs, and anxiety in individuals undergoing urinary tract stone surgery. The study will include three groups: the BGE group, the JPGE group, and the control group. Participants will be assigned to groups using the block randomization method, taking into account the variables of surgical type (RIRS, URS, and PNCL), age, and gender.

Data will be collected using the Patient Information Form prepared by the researchers, the Vital Signs Monitoring Form created by the researcher (consisting of date, time, blood pressure, respiratory rate, pulse, oxygen saturation, and body temperature), the Visual Analog Scale (VAS), and the State-Trait Anxiety Inventory (STAI). The VAS is used for the visual assessment of pain. It is a scale that can be used horizontally or vertically, ranging from "no pain" to "unbearable pain." The STAI is a valid and reliable 40-item measure that assesses individuals' levels of state and trait anxiety (Spielberger et al., 1970). The scale was translated into Turkish by Öner and Le Compte. The necessary permission to use the STAI will be obtained via email. Only the State Anxiety Scale will be used in this study. This scale consists of a total of 20 questions and is a four-point Likert scale. The highest possible score on the scale is 80, and the lowest is 20. As the score increases, the level of anxiety increases.

One day before surgery, patients will be informed about the study, their written informed consent will be obtained, pre-test procedures will be conducted, and the intervention groups will be taught the relevant relaxation exercises. In the postoperative period, once the patient has stabilized, relaxation sessions lasting approximately 20-30 minutes will be conducted on days 0 and 1; immediately following these sessions, assessments using the VAS, vital signs, and the STAI will be performed at the 30th, 60th, and 90th minutes. The control group, on the other hand, will be taught both relaxation techniques prior to discharge. If the anticipated sample size is not reached or if complications arise during the study, the data collection period will be extended.

One of the study's objectives is for the findings to contribute to evidence-based, nonpharmacological nursing interventions that can be used in the postoperative care process and to generate scientific data aimed at improving the quality of patient care.

02

Conditions studied

  • Urinary Tract Stone Surgery
  • Relaxation Exercise
  • Anxiety
  • Vital Signs
  • Postoperative Pain

Keywords

  • Benson Relaxation Exercise
  • Jacobson Relaxation Exercise
  • Urinary Tract Stone Surgery
  • Postoperative care
  • Non-pharmacological intervention
  • Randomized controlled trial
  • Postoperative Pain
  • Vital Signs
03

In context

Anxiety Disorders

5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.

This study's planned enrollment of 120 is above the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Ondokuz Mayıs University is the lead sponsor of 272 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • Adults 18 years of age and older,

      • Open to communication,
      • Individuals undergoing urinary tract stone surgery (URS, PCNL, and RIRS) for the first time under elective conditions.

Exclusion criteria

Exclusion Criteria:

    • Individuals who have previously undergone surgery for urinary tract stones,

      • Individuals who developed any complications following surgery, such as bleeding or anesthesia-related complications,
      • Individuals with cognitive or mental health issues,
      • Participants who wish to withdraw from the study at any stage,
      • Individuals with hearing or speech impairments,
      • Individuals with a psychiatric diagnosis or who are taking psychiatric medication,
      • Individuals who have undergone ESWL (due to its noninvasive nature) or open stone surgery (due to it being a much more invasive surgical approach compared to RIRS, URS, and PCNL),
      • Individuals who are unable to adhere to relaxation exercises.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Benson Relaxation Exercise Group

    Participants in this group will perform the Benson relaxation exercise once they have stabilized following surgery. In addition to routine postoperative care, the exercise will be performed two times a day for two days, with each session lasting approximately fifteen minutes.

    Behavioral: Benson Relaxation Exercise Group

  • Experimental
    Jacobson Relaxation Exercise Group

    Participants in this group will perform the Jacobson relaxation exercise once they have stabilized following surgery. In addition to routine postoperative care, the exercise will be performed two times a day for two days, with each session lasting approximately fifteen minutes.

    Behavioral: Jacobson Relaxation Exercise Group

  • No intervention
    Control Group

    Participants in this group will receive routine postoperative care without any relaxation exercise intervention.

Interventions

  • BehavioralBenson Relaxation Exercise Group

    Individuals who have previously agreed to participate in the study and whose general condition is stable following urinary tract stone surgery will undergo the Benson relaxation exercise for 15 minutes twice daily on postoperative days 0 and 1. Patients will be briefed prior to the session, undergo a pre-test, and be supervised during the session. On the day of the session, all data will be recorded on the patient follow-up form. The exercise is based on assuming a comfortable position, relaxing the muscles, focusing on the breath, and mentally repeating a chosen word or phrase with each exhalation.

    Also known as: Intervention

  • BehavioralJacobson Relaxation Exercise Group

    Individuals who have previously agreed to participate in the study and whose general condition is stable following urinary tract stone surgery will undergo the Jacobson progressive muscle relaxation exercise twice daily for 15 minutes each on postoperative days 0 and 1. Patients will be briefed prior to the session, undergo a pre-test, and be supervised during the session. On the day of the session, all data will be recorded on the patient follow-up form. This exercise is performed by tensing (contracting) each of the body's 16 major muscle groups in turn for 5-10 seconds and then suddenly releasing them completely (relaxing).

    Also known as: Intervention

06

What researchers measure

Primary outcomes

  1. Postoperative Pain Level

    Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-centimeter scale ranging from 0 to 10; on this scale, 0 means "no pain" and 10 means "the most severe pain imaginable." Higher scores indicate greater pain intensity. The scale will be administered on Day 0, once the patient is stable after surgery, and on Day 1 postoperatively at 0, 30, 60, and 90 minutes

    Time frame: Postoperative day 0, and postoperative day 1.

Secondary outcomes

  1. Postoperative Anxiety Level

    Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-State Form), a 20-item self-report questionnaire with a total score ranging from 20 to 80. Higher scores indicate higher levels of anxiety. The scale will be administered on postoperative Day 0 and on postoperative Day 1, at 0, 30, 60, and 90 minutes following each treatment session.

    Time frame: postoperative day 0, and postoperative day 1.

Other outcomes

  1. Vital signs- Changes in Heart Rate

    Heart rate will be assessed by manually counting the patient's radial pulse for one minute. The resulting value will be recorded as the number of heartbeats per minute, and an increase in this measurement will indicate an elevated heart rate.

    Time frame: postoperative day 0, and postoperative day 1.

  2. Vital signs- Changes in Oxygen Saturation

    Oxygen saturation (SpO₂, %) will be measured using a pulse oximeter. Higher values indicate better oxygenation.

    Time frame: postoperative day 0, and postoperative day 1.

  3. Vital signs- Changes in Blood Pressure

    Systolic and diastolic blood pressure (mmHg) will be measured manually using a sphygmomanometer and a stethoscope while the patient is in a comfortable, relaxed position. The systolic and diastolic blood pressure values obtained from the measurement will be recorded in mmHg. An increase in systolic and diastolic blood pressure values indicates a rise in blood pressure, while a decrease in these values indicates a drop in blood pressure.

    Time frame: postoperative day 0, and postoperative day 1.

  4. Vital signs- Changes in Respiratory Rate

    Respiratory rate (number of breaths per minute) will be measured manually by observing chest movements and counting the number of complete inhalations and exhalations over the course of one minute. Higher values indicate an increased respiratory rate.

    Time frame: postoperative day 0, and postoperative day 1.

  5. Vital signs- Changes in Body Temperature

    Body temperature (°C) will be assessed by measuring the patient's body temperature using a thermometer. The value obtained from the measurement will be recorded in degrees Celsius (°C). An increase in body temperature indicates a fever or a rise in body temperature, while a decrease in the value indicates a drop in body temperature.

    Time frame: postoperative day 0, and postoperative day 1.

07

Study locations

1 site
  • Ondokuz Mayıs University Health Application and Research Center
    Samsun, Samsun 55100, Turkey (Türkiye)
    • Ondokuz Mayıs University Ondokuz Mayıs University Health Application and Research Cente · Contact · hastaneweb@omu.edu.tr · (0362) 312 19 19
08

References and documents

Publications

  • Yangoz ST, Karakus Z, Ozer Z. Effect of Benson's Relaxation on Physical, Psychological, and Quality of Life Outcomes in Adults Receiving Hemodialysis: Systematic Review and Meta-Analysis. J Ren Care. 2026 Mar;52(1):e70043. doi: 10.1111/jorc.70043. PubMed 41536165 ↗
  • Spielberger, C. D., Gorsuch, R. L., & Lushene, R. E. (1970). STAI Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.
  • Poorolajal, J., Ashtarani, F., & Alimohammadi, N. (2017). Effect of Benson relaxation technique on the preoperative anxiety and hemodynamic status: A single blind randomized clinical trial. Artery Research, 17, 33-38. https://doi.org/10.1016/j.artres.2017.01.002
  • Pishgooie SAH, Akbari F, Keyvanloo Shahrestanaki S, Rezaei M, Nasiri M, Momen R. Effects of Relaxation Techniques on Acute Postlaminectomy Pain: A Three-Arm Randomized Controlled Clinical Trial. J Perianesth Nurs. 2020 Oct;35(5):533-538. doi: 10.1016/j.jopan.2020.02.004. Epub 2020 May 5. PubMed 32386940 ↗
  • Niyonkuru E, Iqbal MA, Zhang X, Ma P. Complementary Approaches to Postoperative Pain Management: A Review of Non-pharmacological Interventions. Pain Ther. 2025 Feb;14(1):121-144. doi: 10.1007/s40122-024-00688-1. Epub 2024 Dec 17. PubMed 39681763 ↗
  • Kok AY, Eyiler E. Effectiveness of breathing relaxation exercises on pain due to chest tube removal: a systematic review-meta-analysis. J Cardiothorac Surg. 2025 Jul 2;20(1):281. doi: 10.1186/s13019-025-03444-4. PubMed 40604937 ↗
  • Koncicki HM, Brennan F, Vinen K, Davison SN. An Approach to Pain Management in End Stage Renal Disease: Considerations for General Management and Intradialytic Symptoms. Semin Dial. 2015 Jul-Aug;28(4):384-91. doi: 10.1111/sdi.12372. Epub 2015 Apr 11. PubMed 25864854 ↗
  • Muhammad Khir S, Wan Mohd Yunus WMA, Mahmud N, Wang R, Panatik SA, Mohd Sukor MS, Nordin NA. Efficacy of Progressive Muscle Relaxation in Adults for Stress, Anxiety, and Depression: A Systematic Review. Psychol Res Behav Manag. 2024 Feb 1;17:345-365. doi: 10.2147/PRBM.S437277. eCollection 2024. PubMed 38322293 ↗
  • Keihani Z, Jalali R, Shamsi MB, Salari N. Effect of Benson Relaxation on the Intensity of Spinal Anesthesia-Induced Pain After Elective General and Urologic Surgery. J Perianesth Nurs. 2019 Dec;34(6):1232-1240. doi: 10.1016/j.jopan.2019.05.005. Epub 2019 Jul 16. PubMed 31324446 ↗
  • Turan Kavradim S, Yangoz ST, Ozer Z. The Effectiveness of the Benson Relaxation Technique on Anxiety and Hemodynamic Parameters in Patients with Cardiovascular Diseases: A Systematic Review and Meta-Analysis. Clin Nurs Res. 2026 Jul;35(6):332-348. doi: 10.1177/10547738261442767. Epub 2026 May 24. PubMed 42178887 ↗
  • Kothiyal M, Kumar N, Khurana G. Perioperative Complications in Percutaneous Nephrolithotomy: Predictive Risk Factors and Hemodynamic Alterations. Cureus. 2024 Sep 15;16(9):e69488. doi: 10.7759/cureus.69488. eCollection 2024 Sep. PubMed 39416589 ↗
  • Kahreh FS, Abdi A, Khatony A, Salari N, Paveh BK, Aznab M, Naghibzadeh A, Mohammadi M. The Effect of Jacobson Relaxation Technique on Sleep Quality of Patients With Cancer Under Chemotherapy: A Randomized Clinical Trial. SAGE Open Nurs. 2024 Oct 3;10:23779608241286814. doi: 10.1177/23779608241286814. eCollection 2024 Jan-Dec. PubMed 39371424 ↗
  • Jacobson E. Progressive muscle relaxation. Interview behavior. J Abnorm Psychol. 1938;75:18.
  • Ibrahim HA, Elgzar WT, Hablas RM. The Effect of Jacobson's Progressive Relaxation Technique on Postoperative Pain, Activity Tolerance, and Sleeping Quality in Patients Undergoing Gynecological Surgery. Iran J Nurs Midwifery Res. 2021 Jul 20;26(4):295-302. doi: 10.4103/ijnmr.IJNMR_180_20. eCollection 2021 Jul-Aug. PubMed 34422608 ↗
  • Hayes, M. H. S., & Patterson, D. G. (1921).Experimental development of the graphic rating method. Psychological Bulletin, 18, 98-99.
  • Ghorbannejad S, MehdizadehTourzani Z, Kabir K, MansourehYazdkhasti. The effectiveness of Jacobson's progressive muscle relaxation technique on maternal, fetal and neonatal outcomes in women with non-severe preeclampsia: a randomized clinical trial. Heliyon. 2022 Jun 13;8(6):e09709. doi: 10.1016/j.heliyon.2022.e09709. eCollection 2022 Jun. PubMed 35761936 ↗
  • GBD 2021 Urolithiasis Collaborators. The global, regional, and national burden of urolithiasis in 204 countries and territories, 2000-2021: a systematic analysis for the Global Burden of Disease Study 2021. EClinicalMedicine. 2024 Nov 21;78:102924. doi: 10.1016/j.eclinm.2024.102924. eCollection 2024 Dec. PubMed 39640943 ↗
  • Burlukkara S, Demir DO, Baran O. The effect of music therapy on anxiety and pain scores in patients undergoing retrograde intrarenal surgery (RIRS) under spinal anesthesia: a prospective, randomized controlled clinical trial. Urolithiasis. 2024 Oct 14;52(1):146. doi: 10.1007/s00240-024-01636-6. PubMed 39402210 ↗
  • Bernstein, D. A., Carlson, C. R. (1993). Progressive relaxation: Abbreviated methods. In P. M. Lehrer & R. L. Woolfolk (Eds.), Principles and practice of stress management (2nd ed.) (pp. 53-87). New York: The Guilford Press.
  • Benson H. The relaxation response: history, physiological basis and clinical usefulness. Acta Med Scand Suppl. 1982;660:231-7. doi: 10.1111/j.0954-6820.1982.tb00378.x. PubMed 6958190 ↗
  • Bargagli M, Scoglio M, Howles SA, Fuster DG. Kidney stone disease: risk factors, pathophysiology and management. Nat Rev Nephrol. 2025 Nov;21(11):794-808. doi: 10.1038/s41581-025-00990-x. Epub 2025 Aug 11. PubMed 40790363 ↗
  • Bagheri M, Abbasi A, Kurdi S, Moslemi F, Mottahedi M. Music therapy and Benson relaxation in postoperative care: A randomized controlled trial on pain and kinesiophobia after lumbar discectomy. Explore (NY). 2026 Mar-Apr;22(2):103311. doi: 10.1016/j.explore.2025.103311. Epub 2025 Dec 24. PubMed 41483731 ↗
  • Bagheri H, Moradi-Mohammadi F, Khosravi A, Ameri M, Khajeh M, Chan SW, Abbasinia M, Mardani A. Effect of Benson and progressive muscle relaxation techniques on sleep quality after coronary artery bypass graft: A randomized controlled trial. Complement Ther Med. 2021 Dec;63:102784. doi: 10.1016/j.ctim.2021.102784. Epub 2021 Oct 20. PubMed 34687869 ↗
  • Aslan, F. E. (2002). Ağrı değerlendirme yöntemleri. Cumhuriyet Üniversitesi Hemşirelik Yüksekokulu, 6, 9-15.
  • Abu Maloh HIA, Soh KL, Chong SC, Ismail SIF, Soh KG, Abu Maloh DI, AbuRuz ME. Efficacy of Benson's Relaxation Technique on Stress and Pain Among Patients Undergoing Maintenance Hemodialysis: A Systematic Review. SAGE Open Nurs. 2024 May 6;10:23779608241251663. doi: 10.1177/23779608241251663. eCollection 2024 Jan-Dec. PubMed 38715771 ↗

Individual participant data

Plan to share: Undecided — The process for sharing participants' personal data has not yet been finalized. Decisions regarding data sharing will be made after the study is completed, taking into account relevant institutional policies, ethical principles, and privacy requirements.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07873008
Responsible party
Özge İşeri (Associate Professor of Surgical Nursing, Ondokuz Mayıs University) — Principal investigator
First posted
Oct 14, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Jul 30, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Oct 14, 2026

Study contacts

Meryem TUNÇ, MSc
Contact
krmzmeryem9@gmail.com
5330765335
Özge İŞERİ, Associate Professor
Contact
ozgepekiniseri@gmail.com
5433997496 ext. 3623121919
Özge İŞERİ, Assistant Professor
principal investigator · Ondokuz Mayıs University, Faculty of Health Sciences, Department of Nursing, Samsun, Türkiye

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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