The Effect of a Sensory Modulation Room Applied in the Preoperative Period on Pain, Anxiety, and Sleep in Kidney Transplantation: An Innovative Nursing Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Postoperative Pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Preoperative Sensory Modulation Session (Behavioral)
结局指标
主要结局
Postoperative Pain
时间窗: Postoperative Day 3
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.
次要结局
- Preoperative and Postoperative Anxiety(Preoperative and Postoperative Day 3)
研究者
gülcan yiğit
PhD Candidate in Surgical Nursing
Sakarya University
