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

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

Overview

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.

Interventions

• Behavioral 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 que

Primary outcome measures

• Postoperative Pain [Time frame: Postoperative Day 3]

Secondary outcome measures (1)

• Preoperative and Postoperative Anxiety [Time frame: Preoperative and Postoperative Day 3]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Sakarya University Training and Research Hospital — Sakarya

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 33597577

Identifiers

NCT: NCT07533669 · E-43012747-050.04-533621-570

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗