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Renal TransplantationSMRT-KTNCT07533669

Effect of a Preoperative Sensory Modulation Room on Pain, Anxiety, and Sleep in Kidney Transplant Patients

A study testing Preoperative Sensory Modulation Session in people with Renal Transplantation and Transplant Donation, run by Sakarya University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Preoperative Sensory Modulation Session
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2025to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 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

Who cannot join

  • 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

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, 1 recruiting
  • Sakarya University Training and Research Hospital

    Sakarya

    GÜLCAN YİĞİT, PHD CANDİDATE, +905316526551, gulcan.yigit1@ogr.sakarya.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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).
Read more

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.

Being tested
Preoperative Sensory Modulation Session
Keywords
Renal Transplantation, Sleep, pain, postoperative period, Nursing Care, Anxiety, preoperative period, sensory modulation room
Medical subject headings
Pain, Anxiety Disorders

What participants receive

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

  • Preoperative Sensory Modulation SessionBehavioural

    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.

Study groups in NCT07533669
Study groupRoleWhat they receive
Preoperative Sensory Modulation SessionExperimentalParticipants 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.
Receives: Behavioral: Preoperative Sensory Modulation Session
Control Group - Standard Preoperative CareNo interventionParticipants 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 being measured

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

  1. 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.

    Measured: Postoperative Day 3

Secondary outcomes (1)
  1. 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.

    Measured: Preoperative and Postoperative Day 3

Timeline

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

  1. First posted16 Apr 2026
  2. Study start1 Dec 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07533669
Sponsor's protocol ID
E-43012747-050.04-533621-570
Acronym
SMRT-KT
Status last verified
Apr 2026
First submitted
3 Apr 2026
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To protect participant privacy and comply with ethical and legal regulations, individual patient-level data will not be publicly shared.

Publications

  • Temür B. N. (2020). Böbrek nakli alıcılarının donör özelliklerine göre algılanan kaygı düzeylerinin belirlenmesi. Yüksek Lisans Tezi, Akdeniz Üniversitesi, Sağlık Bilimleri Enstitüsü, Hemşirelik ABD, Antalya.

  • Tadesse M, Ahmed S, Regassa T, Girma T, Hailu S, Mohammed A, Mohammed S. Effect of preoperative anxiety on postoperative pain on patients undergoing elective surgery: Prospective cohort study. Ann Med Surg (Lond). 2021 Dec 22;73:103190. doi: 10.1016/j.amsu.2021.103190. eCollection 2022 Jan.

    PubMed 35070278
  • Won E, Kim YK. Stress, the Autonomic Nervous System, and the Immune-kynurenine Pathway in the Etiology of Depression. Curr Neuropharmacol. 2016;14(7):665-73. doi: 10.2174/1570159x14666151208113006.

    PubMed 27640517
  • Otsuka H, Irie K, Kogata T, Onitsuka A, Inadomi H. Effects of sensory room intervention on autonomic function in healthy adults: A pilot randomized controlled trial. PLoS One. 2025 Apr 23;20(4):e0319649. doi: 10.1371/journal.pone.0319649. eCollection 2025.

    PubMed 40267087
  • 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.

  • Pan WT, Ji MH, Ma D, Yang JJ. Effect of perioperative autonomic nervous system imbalance on surgical outcomes: a systematic review. Br J Anaesth. 2025 Sep;135(3):608-622. doi: 10.1016/j.bja.2025.06.004. Epub 2025 Jul 4.

    PubMed 40615330
  • Ni K., Zhu J., Ma Z. (2023). Preoperative anxiety and postoperative adverse events: A narrative overview. Anesthesiology and Perioperative Science, 1(23). doi:10.1007/s44254-023-00019-1

  • Mostajeran F, Krzikawski J, Steinicke F, Kuhn S. Effects of exposure to immersive videos and photo slideshows of forest and urban environments. Sci Rep. 2021 Feb 17;11(1):3994. doi: 10.1038/s41598-021-83277-y.

    PubMed 33597577
  • Lane SJ, Mailloux Z, Schoen S, Bundy A, May-Benson TA, Parham LD, Smith Roley S, Schaaf RC. Neural Foundations of Ayres Sensory Integration(R). Brain Sci. 2019 Jun 28;9(7):153. doi: 10.3390/brainsci9070153.

    PubMed 31261689
  • 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.

  • Kulakac N., Aydin Sayilan A. (2024). The effect of perceived preoperative nursing care and surgical anxiety on postoperative recovery. Balikesir Health Sciences Journal, 13(3), 572-579. doi:10.53424/balikesirsbd.1507055

  • 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. Sensory processing, autonomic nervous function, and social participation in people with mental illnesses. Hong Kong J Occup Ther. 2023 Jun;36(1):39-47. doi: 10.1177/15691861231177355. Epub 2023 May 14.

    PubMed 37332298
  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Preoperative Sensory Modulation Session in people with Renal Transplantation and Transplant Donation, run by Sakarya 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact GÜLCAN YİĞİT (+905316526551, gulcan.yigit1@ogr.sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain (time frame: Postoperative Day 3). 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 NCT07533669, which also lists 31 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 1 May 2026.

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