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| Name | Class |
|---|---|
| Sakarya University Education and Research Hospital | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Sensory Modulation Session | Experimental | 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. |
|
| Control Group - Standard Preoperative Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Sensory Modulation Session | Behavioral | 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. |
| 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 |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GÜLCAN YİĞİT | Contact | +905316526551 | gulcan.yigit1@ogr.sakarya.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Dilek Aygin | Sakarya University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sakarya University Training and Research Hospital | Recruiting | Sakarya | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 35070278 | Background | 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. | |
| 27640517 |
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To protect participant privacy and comply with ethical and legal regulations, individual patient-level data will not be publicly shared.
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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|
| 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 |
| Background |
| 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. |
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