An interventional study of White Noise in Procedural Anxiety and Physiological Stress, sponsored by Yuzuncu Yil University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Yuzuncu Yil University · Not applicable, Interventional, and Supportive care
This randomized controlled trial aims to determine whether white noise affects salivary cortisol levels and vital signs in adult patients undergoing gastroscopy. Participants will be randomly assigned to either a white noise group or a control group receiving routine care. Patients in the intervention group will listen to white noise in accordance with the study protocol. Saliva samples will be collected to assess cortisol levels, and vital signs will be measured at predetermined time points. The results of the two groups will be compared to evaluate whether white noise helps reduce the physiological stress response associated with gastroscopy.
Gastroscopy may cause procedural stress due to uncertainty, swallowing of the endoscope, the gag reflex, and environmental noise. This stress may activate the sympathetic nervous system and the hypothalamic-pituitary-adrenal axis, resulting in changes in vital signs and increased cortisol secretion. White noise is a non-pharmacological intervention that may mask environmental sounds and reduce auditory stimulation. However, evidence regarding its effect on an objective biochemical stress marker in patients undergoing gastroscopy under sedation remains limited.
This single-center randomized controlled trial will include 100 adult patients scheduled for elective diagnostic gastroscopy under sedation. Participants will be assigned to the white noise intervention group or the routine care control group using computer-generated block randomization, with 50 participants planned for each group. Before sedation, demographic and clinical information will be collected, baseline vital signs will be recorded, and participants will rate their anxiety and pain using 0-10 visual analog scales. A baseline saliva sample will then be collected for cortisol measurement.
Participants assigned to the intervention group will begin listening to white noise through headphones with disposable protective covers immediately before entering the endoscopy room, while they are still awake. The intervention will continue without interruption during sedation induction and throughout the gastroscopy procedure. Participants in the control group will receive routine care without an auditory intervention. Vital signs, including systolic and diastolic blood pressure, heart rate, respiratory rate, and oxygen saturation, will be recorded at baseline, during the fifth minute of the procedure, and during recovery.
The white noise intervention will be discontinued when the procedure is completed. Anxiety and pain will be reassessed after the procedure. A second saliva sample will be collected approximately 20-30 minutes after the procedure to account for the expected salivary cortisol response. Saliva samples will be maintained under appropriate cold-chain conditions and stored until cortisol concentrations are measured using an enzyme-linked immunosorbent assay. Changes in salivary cortisol, vital signs, anxiety, and pain will be compared between the intervention and control groups.
Exclusion Criteria:
Participants will receive routine care and listen to white noise through headphones beginning immediately before entering the endoscopy room. White noise will continue uninterrupted during sedation induction and throughout the gastroscopy procedure and will be discontinued when the procedure is completed.
Behavioral: White Noise
Participants will receive routine care provided by the endoscopy unit without any auditory intervention during the gastroscopy procedure.
White noise will be delivered through headphones with disposable protective covers, beginning immediately before the participant enters the endoscopy room and continuing uninterrupted during sedation induction and throughout the gastroscopy procedure.
Change in Salivary Cortisol Level
Salivary cortisol concentration will be measured using an enzyme-linked immunosorbent assay (ELISA). The change from baseline will be calculated by subtracting the pre-procedure cortisol concentration from the post-procedure concentration and compared between the white noise and routine care groups. Higher cortisol concentrations indicate a greater physiological stress response.
Time frame: Perioperative and Periprocedural
Change in Systolic Blood Pressure
Systolic blood pressure will be measured in millimeters of mercury (mmHg). Changes from the pre-procedure baseline will be compared between the white noise and routine care groups.
Time frame: Perioperative and Periprocedural
Change in Diastolic Blood Pressure
Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Changes from the pre-procedure baseline will be compared between the white noise and routine care groups.
Time frame: Perioperative and Periprocedural
Change in Heart Rate
Heart rate will be measured in beats per minute. Changes from the pre-procedure baseline will be compared between the white noise and routine care groups.
Time frame: Perioperative and Periprocedural
Change in Respiratory Rate
Respiratory rate will be measured in breaths per minute. Changes from the pre-procedure baseline will be compared between the white noise and routine care groups.
Time frame: Perioperative and Periprocedural
Change in Peripheral Oxygen Saturation
Peripheral oxygen saturation will be measured as a percentage using pulse oximetry. Changes from the pre-procedure baseline will be compared between the white noise and routine care groups. Higher percentages indicate greater oxygen saturation.
Time frame: Perioperative and Periprocedural
Change in Patient-Reported Anxiety
Anxiety will be assessed using a 10-centimeter Visual Analog Scale ranging from 0 to 10, where 0 indicates no anxiety and 10 indicates the worst possible anxiety. The change from the pre-procedure score to the post-procedure score will be compared between groups.
Time frame: Perioperative and Periprocedural
Change in Patient-Reported Pain
Pain will be assessed using a 10-centimeter Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. The change from the pre-procedure score to the post-procedure score will be compared between groups.
Time frame: Perioperative and Periprocedural
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Yuzuncu Yil University