Effect of a Preoperative Sensory Modulation Room on Pain, Anxiety, and Sleep in Kidney Transplant Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSakarya University
About this trial
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
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Sequential
Treatments tested in this trial
Preoperative Sensory Modulation Session
BehavioralParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Preoperative Sensory Modulation SessionExperimental treatment 1 intervention
Group B: Control Group - Standard Preoperative CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
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.
Time frame
Postoperative Day 3Secondary outcomes
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.
Time frame
Preoperative and Postoperative Day 3Other outcomes
1
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.
Time frame
Preoperative (baseline)2
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.
Time frame
in the preoperative period and on postoperative day 3Sponsors and contacts
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Sakarya University
Lead sponsor
Sakarya University Education and Research Hospital
Collaborator
Source ClinicalTrials.gov