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

NCT07533669 | Not Yet Recruiting

• 1 other identifier: E-43012747-050.04-533621-570
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Transplantation; Nursing Care; Sensory Modulation Room; Transplant Donation; Transplant Patients; Transplant Recipient (Kidney); Donor Nephrectomy; Donor

Keywords

Renal Transplantation; Sleep; pain; postoperative period; Nursing Care; Anxiety; preoperative period; sensory modulation room

Outcome Measures

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.

  Postoperative Day 3

Secondary Outcomes (1)

• Preoperative and Postoperative Anxiety

  Preoperative and Postoperative Day 3

Other Outcomes (2)

• Individual Sensory Processing Profile

  Preoperative (baseline)

• Insomnia Severity

  in the preoperative period and on postoperative day 3

Study Arms (2)

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.

Behavioral: Preoperative Sensory Modulation Session

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.

Interventions

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.

Preoperative Sensory Modulation Session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead
• Sakarya University Education and Research Hospital: collaborator

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MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Dilek Aygin

  Sakarya University

  STUDY DIRECTOR

Central Study Contacts

GÜLCAN YİĞİT

CONTACT

+905316526551; gulcan.yigit1@ogr.sakarya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate in Surgical Nursing

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 16, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share