Urinary Tract Stone SurgeryRelaxation-RCTNCT07873008
Relaxation Exercise Interventions for Individuals Who Have Undergone Urinary Tract Stone Surgery
A study testing Benson Relaxation Exercise Group and Jacobson Relaxation Exercise Group in people with Urinary Tract Stone Surgery and Relaxation Exercise, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Stone Surgery, Relaxation Exercise, Anxiety
- What is being tested?
- Benson Relaxation Exercise Group and Jacobson Relaxation Exercise Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2027to 31 Oct 2027
- Phase
- Interventional
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ondokuz Mayıs University Health Application and Research Center
Samsun, Samsun, 55100
Ondokuz Mayıs University Ondokuz Mayıs University Health Application and Research Cente, (0362) 312 19 19, hastaneweb@omu.edu.tr
About this study
Official title: After Urinary Tract Stone Surgery A Comparison of Benson and Jacobson Relaxation Exercises in the Management of Postoperative Pain, Anxiety, and Quality of Life: A Randomized Controlled Trial
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.
- Conditions
- Urinary Tract Stone Surgery, Relaxation Exercise, Anxiety, Vital Signs, Postoperative Pain
- Being tested
- Benson Relaxation Exercise Group, Jacobson Relaxation Exercise Group
- Keywords
- Benson Relaxation Exercise, Jacobson Relaxation Exercise, Urinary Tract Stone Surgery, Postoperative care, Non-pharmacological intervention, Randomized controlled trial, Postoperative Pain, Vital Signs
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benson Relaxation Exercise GroupBehavioural
Also called Intervention
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.
Jacobson Relaxation Exercise GroupBehavioural
Also called Intervention
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).
| Study group | Role | What they receive |
|---|---|---|
| Benson Relaxation Exercise Group | Experimental | 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. Receives: Behavioral: Benson Relaxation Exercise Group |
| Jacobson Relaxation Exercise Group | Experimental | 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. Receives: Behavioral: Jacobson Relaxation Exercise Group |
| Control Group | No intervention | Participants in this group will receive routine postoperative care without any relaxation exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: postoperative day 0, and postoperative day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Stone SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to three parallel groups: a Benson relaxation exercise group, a Jacobson relaxation exercise group, and a control group receiving routine postoperative care.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge İşeri, Ondokuz Mayıs University
- Investigators
- Özge İŞERİ, Assistant Professor, Principal investigator, Ondokuz Mayıs University, Faculty of Health Sciences, Department of Nursing, Samsun, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873008
- Sponsor's protocol ID
- 2026-988
- Acronym
- Relaxation-RCT
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 41536165Spielberger, 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 32386940Niyonkuru 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 39681763Kok 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 40604937Koncicki 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 25864854Muhammad 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 38322293Keihani 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 31324446Turan 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 42178887Kothiyal 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 39416589Kahreh 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 39371424Jacobson 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 34422608Hayes, M. H. S., & Patterson, D. G. (1921).Experimental development of the graphic rating method. Psychological Bulletin, 18, 98-99.