NCT07533669 Effect of a Preoperative Sensory Modulation Room on Pain, Anxiety, and Sleep in Kidney Transplant Patients
| NCT ID | NCT07533669 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sakarya University |
| Condition | Renal Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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
Contact & Investigator
Dilek Aygin
STUDY DIRECTOR
Sakarya University
Frequently Asked Questions
Who can join the NCT07533669 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07533669 currently recruiting?
Yes, NCT07533669 is actively recruiting participants. Contact the research team at gulcan.yigit1@ogr.sakarya.edu.tr for enrollment information.
Where is the NCT07533669 trial being conducted?
This trial is being conducted at Sakarya, Turkey (Türkiye).
Who is sponsoring the NCT07533669 clinical trial?
NCT07533669 is sponsored by Sakarya University. The principal investigator is Dilek Aygin at Sakarya University. The trial plans to enroll 40 participants.