Effect of White Noise on Salivary Cortisol and Vital Signs During Gastroscopy
The Effect of White Noise on Salivary Cortisol Levels and Vital Signs in Patients Undergoing Gastroscopy: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zeynep GÜRKAN, PhD
- Phone Number: +905389786500
- Email: zeynepgurkan@yyu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 years or older
- Scheduled for elective diagnostic gastroscopy under sedation
- Able to communicate in Turkish
- Able to hear the white noise intervention and without hearing loss that would prevent its use
- Willing to participate voluntarily and able to provide written informed consent
Exclusion Criteria:
- Undergoing emergency gastroscopy
- Diagnosed psychiatric disorder or current use of psychotropic medication that may affect anxiety
- Hearing impairment that would prevent effective delivery of the white noise intervention
- Use of systemic, topical, or inhaled glucocorticoids within the previous month
- Diagnosed adrenal or pituitary gland disorder
- Pregnant or breastfeeding
- Active oral lesions, gingival bleeding, or severe periodontitis that may compromise saliva sample quality
- Smoking or consumption of caffeinated beverages within two hours before the procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: White Noise Intervention Group
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.
|
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.
|
|
No Intervention: Routine Care Control Group
Participants will receive routine care provided by the endoscopy unit without any auditory intervention during the gastroscopy procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Salivary Cortisol Level
Time Frame: Perioperative and Periprocedural
|
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.
|
Perioperative and Periprocedural
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Systolic Blood Pressure
Time Frame: Perioperative and Periprocedural
|
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.
|
Perioperative and Periprocedural
|
|
Change in Diastolic Blood Pressure
Time Frame: Perioperative and Periprocedural
|
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.
|
Perioperative and Periprocedural
|
|
Change in Heart Rate
Time Frame: Perioperative and Periprocedural
|
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.
|
Perioperative and Periprocedural
|
|
Change in Respiratory Rate
Time Frame: Perioperative and Periprocedural
|
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.
|
Perioperative and Periprocedural
|
|
Change in Peripheral Oxygen Saturation
Time Frame: Perioperative and Periprocedural
|
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.
|
Perioperative and Periprocedural
|
|
Change in Patient-Reported Anxiety
Time Frame: Perioperative and Periprocedural
|
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.
|
Perioperative and Periprocedural
|
|
Change in Patient-Reported Pain
Time Frame: Perioperative and Periprocedural
|
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.
|
Perioperative and Periprocedural
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Sogabe M, Okahisa T, Fukuya A, Kagemoto K, Okada Y, Adachi Y, Kurihara T, Nii T, Teramae S, Tanaka H, Tomonari T, Okamoto K, Miyamoto H, Nakasono M, Takayama T. Effects of audio and visual distraction on patients' vital signs and tolerance during esophagogastroduodenoscopy: a randomized controlled trial. BMC Gastroenterol. 2020 Apr 21;20(1):122. doi: 10.1186/s12876-020-01274-3.
- Demirci S, Sezer S. Effect of Binaural Beats on Anxiety and Tolerance in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation: A Randomized Controlled Trial. J Integr Complement Med. 2024 Dec;30(12):1209-1216. doi: 10.1089/jicm.2023.0804. Epub 2024 Aug 1.
- Genc H, Tanriverdi S. The Effects of a Portative Glass Waterfall and a White Noise App On Pain, Anxiety, and Physiological Parameters During Gastroscopy. Pain Manag Nurs. 2026 Feb;27(1):e103-e111. doi: 10.1016/j.pmn.2025.10.001. Epub 2025 Oct 22.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2026/07-07
- 13402 (Other Grant/Funding Number: Van Yüzüncü Yıl University Scientific Research Projects Coordination Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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