Effect of a Preoperative Sensory Modulation Room on Pain, Anxiety, and Sleep in Kidney Transplant Patients (SMRT-KT)

The Effect of a Sensory Modulation Room Applied in the Preoperative Period on Pain, Anxiety, and Sleep in Kidney Transplantation: An Innovative Nursing Intervention

The goal of this prospective study is to evaluate whether preoperative exposure to a sensory modulation room can influence postoperative pain, anxiety, and sleep outcomes in adult living kidney donors and recipients. Organ transplantation involves complex surgical experiences that generate substantial physiological and psychological stress. Increased preoperative anxiety, sleep disturbances, and pain perception can adversely affect surgical outcomes and postoperative recovery. Given the limited availability of non-pharmacological nursing interventions for preoperative stress management, examining the effects of sensory modulation as a non-pharmacological approach is of clinical importance. The main questions this study aims to answer are:

• Does preoperative exposure to a sensory modulation room reduce postoperative pain levels compared to standard care?
• Does preoperative exposure to a sensory modulation room reduce preoperative and postoperative anxiety compared to standard care?
• Does preoperative exposure to a sensory modulation room improve postoperative sleep quality compared to standard care?
• How do individual sensory processing profiles influence the effectiveness of sensory modulation on postoperative pain, anxiety, and sleep? Comparison group: Researchers will compare participants who undergo preoperative sensory modulation (intervention group) to participants receiving standard preoperative care (control group) to determine differences in postoperative pain, anxiety, and sleep quality. Participants will: Be adult living kidney donors and recipients scheduled for elective transplantation at the Sakarya Training and Research Hospital Organ Transplant Unit. Undergo a single 15-20 minute sensory modulation session in a specially designed preoperative room equipped with dim lighting, nature videos, relaxing music, and tactile objects (stress balls, grounding mats).

Complete a structured sequence during the intervention: orientation (0-5 min), visual stimulation with nature video (5-10 min), auditory stimulation with music (10-15 min), free sensory exploration (15-20 min), followed by questionnaires assessing immediate effects (20-25 min).

Complete study instruments including a Demographic Information Form, the Adult Sensory Processing Questionnaire, the Surgical Anxiety Scale, the Athens Insomnia Scale, and a Visual Analogue Scale for pain. Be monitored postoperatively, with primary outcomes (pain, anxiety, and sleep quality) measured on postoperative day 3 to ensure clinical stability and reliable self-reporting. The study sample is planned to include 40 participants (20 donors and 20 recipients) using sequential assignment rather than randomization to minimize cross-group interaction and behavioral contamination. Control group participants will receive routine preoperative care including surgical preparation, laboratory testing, and standard clinical monitoring, without structured relaxation or sensory modulation interventions. All participants will be evaluated at identical time points using the same assessment tools.

It has received ethical approval from the Sakarya University Health Sciences Scientific Research Ethics Committee (Date: 18.11.2025, Approval No: E-43012747-050.04-533621-570), and informed consent will be obtained from all participants in accordance with the Declaration of Helsinki. Data analysis will be conducted using SPSS 25.0.

Study Overview

• Status: Recruiting
• Conditions: Renal Transplantation; Transplant Donation; Donor Nephrectomy
• Intervention / Treatment: Behavioral: Preoperative Sensory Modulation Session

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GÜLCAN YİĞİT; Phone Number: +905316526551; Email: gulcan.yigit1@ogr.sakarya.edu.tr

Study Locations

• Turkey (Türkiye)
  • Sakarya, Turkey (Türkiye)
    • Recruiting
    • Sakarya University Training and Research Hospital
    • Contact: GÜLCAN YİĞİT, PHD CANDİDATE; Phone Number: +905316526551; Email: gulcan.yigit1@ogr.sakarya.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Be 18 years of age or older
• Be involved as a donor or recipient in a living kidney transplant process
• Be scheduled for elective surgical admission
• Have adequate cognitive function and mental stability (fully oriented, able to cooperate)
• Willing to participate in the study and provide written informed consent

Exclusion Criteria:

• Undergoing emergency organ transplantation
• Presence of impaired consciousness, severe cognitive deficits, or a diagnosed psychiatric disorder
• Severe loss of vision, hearing, or tactile sensation that prevents perception of sensory modulation stimuli
• Refusal to complete assessment scales or withdrawal from the study during the study process

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoperative Sensory Modulation Session; Participants will undergo a 15-20 minute session in a specially designed sensory modulation room after completing the first part of the informational consent form. The room is equipped with dim lighting, nature videos, calming music, tactile objects (stress balls, grounding mat), and relaxing audiovisual stimuli. The intervention follows a structured protocol: 0-5 min orientation, 5-10 min nature video, 10-15 min music listening, 15-20 min free sensory exploration, and 20-25 min post-session questionnaire. Duration, content, and environmental conditions are standardized for all participants and delivered by a single trained researcher. This intervention aims to promote attention regulation, sensory modulation, and autonomic nervous system balance. It is a single-session, structured experimental intervention applied in addition to standard preoperative care in kidney transplant patients.	Behavioral: Preoperative Sensory Modulation Session; Participants will undergo a 15-20 minute session in a specially designed sensory modulation room after completing the first part of the informational consent form. The room is equipped with dim lighting, nature videos, calming music, tactile objects (stress balls, grounding mat), and relaxing audiovisual stimuli. The intervention follows a structured protocol: 0-5 min orientation, 5-10 min nature video, 10-15 min music listening, 15-20 min free sensory exploration, and 20-25 min post-session questionnaire. Duration, content, and environmental conditions are standardized for all participants and delivered by a single trained researcher. This intervention aims to promote attention regulation, sensory modulation, and autonomic nervous system balance. It is a single-session, structured experimental intervention applied in addition to standard preoperative care in kidney transplant patients.
No Intervention: Control Group - Standard Preoperative Care; Participants will receive standard preoperative care, including surgical preparation, laboratory testing, vital sign monitoring, and routine preoperative education provided by the transplant unit staff. No structured relaxation or sensory modulation intervention will be applied. All assessments will be conducted at the same time points and using the same measurement tools as the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	Patient-reported pain intensity assessed using the Visual Analogue Scale (min:0-max:10), with 0 indicating no pain and 10 indicating worst imaginable pain.	Postoperative Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative and Postoperative Anxiety	Anxiety levels measured using the Surgical Anxiety Scale, with higher scores indicating greater anxiety.It is a five-point Likert-type scale with a possible score range of 0-68, where higher scores indicate higher levels of anxiety.	Preoperative and Postoperative Day 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual Sensory Processing Profile	Assessed using the Adult Sensory Processing Scale to determine sensory processing patterns and their influence on the effectiveness of sensory modulation intervention.The scale consists of a total of 48 items, which are grouped under 11 factors. These factors are structured to capture patterns of over-responsiveness, under-responsiveness, and sensory seeking. The items reflect situations commonly encountered in daily life (e.g., discomfort in noisy environments, sensitivity to bright lights, avoidance of certain clothing textures) and are designed to assess an individual's responses to sensory stimuli. Each item is rated on a five-point Likert scale (1 = Never, 5 = Always). Factor scores indicate whether an individual's sensory processing within a specific system falls within the typical range or reflects possible or definite difficulties. Higher scores indicate greater difficulty in sensory processing within the respective domain.	Preoperative (baseline)
Insomnia Severity	The Athens Insomnia Scale consists of items covering both nighttime and daytime dimensions of sleep, including sleep onset, nighttime awakenings, early morning awakening, total sleep duration, sleep quality, as well as daytime well-being, functional capacity, and daytime sleepiness. Each item is scored on a scale from 0 to 3, with higher total scores indicating greater severity of insomnia. Scores of 6 or above suggest the presence of clinically significant insomnia.	in the preoperative period and on postoperative day 3

Collaborators and Investigators

• Sponsor: Sakarya University
• Collaborators: Sakarya University Education and Research Hospital
• Investigators: Study Director: Dilek Aygin, Sakarya University

Publications and helpful links

General Publications

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• Won, E., & Kim, Y.-K. (2016). Stress, the Autonomic Nervous System, and the Immune-kynurenine Pathway in the Etiology of Depression. Current Neuropharmacology, 14(7), 665. https://doi.org/10.2174/1570159x14666151208113006
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• Ok D. (2023). Böbrek transplantasyonu sonrası hastalarda semptom oluşma ve rahatsızlık durumu, yaşam kalitesi ve ilişkili faktörler. Yüksek Lisans Tezi, Pamukkale Üniversitesi, Sağlık Bilimleri Enstitüsü, Hemşirelik Esasları Programı, Denizli.
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• Lane, S. J., Mailloux, Z., Schoen, S., Bundy, A., May-Benson, T. A., Parham, L. D., Roley, S. S., & Schaaf, R. C. (2019). Neural Foundations of Ayres Sensory Integration®. Brain Sciences, 9(7), 153. https://doi.org/10.3390/brainsci9070153
• Küçük İ. F. (2024). Canlı vericili böbrek naklinde donör nefrektomi yapılan olgularda böbrek disfonksiyonunu etkileyen parametreler. Uzmanlık Tezi, Sakarya Üniversitesi Tıp Fakültesi, Genel Cerrahi ABD, Sakarya.
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• Karakılçık B. Böbrek nakli alıcılarında enfeksiyondan korunma davranışları ve öz yönetim düzeyleri arasındaki ilişkinin incelenmesi. Yüksek Lisans Tezi, Dokuz Eylül Üniversitesi, Sağlık Bilimleri Enstitüsü, Hemşirelik ABD, İzmir.
• Janeczko, E., Woźnicka, M., Kędziora, W., Janeczko, K., Śmietańska, K., Podziewski, P., & Górski, J. (2024). Effect of Exposure to 2D Video of Forest Environment with Natural Forest Sound on Psychological Well-Being of Healthy Young Adults. Forests 2024, Vol. 15, Page 1549, 15(9), 1549. https://doi.org/10.3390/f15091549
• Hattori R., Irie K., Mori T., Tsurumi K., Murai T., Inadomi H. (2023). Sensory processing, autonomic nervous function, and social participation in people with mental illnesses. Hong Kong Journal of Occupational Therapy, 36(1), 39-47. doi:10.1177/15691861231177355
• Haberal G. (2021). Böbrek nakli vericilerinde uzun süreli takip sonucunda kronik böbrek hastalığı gelişme riski ve etkili faktörler. Uzmanlık Tezi, Hacettepe Üniversitesi Tıp Fakültesi, İç Hastalıkları ABD, Ankara.
• Gümüş G., Duru A. D. (2025). Kısa dönem yoga uygulamalarının merkezi sinir sistemi ve bilişsel performans üzerindeki rolü: Elektrofizyolojik bir yaklaşım. Eurasian Research in Sport Science (ERISS), 10(1), 42-56. doi:10.29228/ERISS.55
• Goel, S. K., Kim, V., Kearns, J., Sabo, D., Zoeller, L., Conboy, C., Kelm, N., Jackovich, A. E., & Chelly, J. E. (2024). Music-Based Therapy for the Treatment of Perioperative Anxiety and Pain-A Randomized, Prospective Clinical Trial. Journal of Clinical Medicine 2024, Vol. 13, Page 6139, 13(20), 6139. https://doi.org/10.3390/jcm13206139
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• Annerstedt, M., Jönsson, P., Wallergård, M., Johansson, G., Karlson, B., Grahn, P., Hansen, Å. M., & Währborg, P. (2022). Short virtual nature breaks in the office environment can restore stress: An experimental study. Journal of Environmental Psychology, 84, 101909. https://doi.org/10.1016/j.physbeh.2013.05.023
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Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pain; Renal Transplantation; Anxiety; Sleep; Nursing Care; preoperative period; postoperative period; sensory modulation room
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: E-43012747-050.04-533621-570

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect participant privacy and comply with ethical and legal regulations, individual patient-level data will not be publicly shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No