Effect of White Noise on Salivary Cortisol and Vital Signs During Gastroscopy

NCT07798934 | Not Yet Recruiting

• 2 other identifiers: 2026/07-0713402
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Procedural Anxiety; Physiological Stress

Keywords

White Noise; Gastroscopy; Salivary Cortisol; Vital Signs; Procedural Anxiety; Physiological Stress; Nursing Intervention; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Perioperative and Periprocedural

Secondary Outcomes (7)

• Change in Systolic Blood Pressure

  Perioperative and Periprocedural

• Change in Diastolic Blood Pressure

  Perioperative and Periprocedural

• Change in Heart Rate

  Perioperative and Periprocedural

• Change in Respiratory Rate

  Perioperative and Periprocedural

• Change in Peripheral Oxygen Saturation

  Perioperative and Periprocedural

Study Arms (2)

White Noise Intervention Group

EXPERIMENTAL

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

Routine Care Control Group

NO INTERVENTION

Participants will receive routine care provided by the endoscopy unit without any auditory intervention during the gastroscopy procedure.

Interventions

White Noise BEHAVIORAL

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.

White Noise Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead
• Van Yüzüncü Yıl University Scientific Research Projects Coordination Unit: collaborator

Related Publications (3)

• 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.

  PMID: 32316918 RESULT

• 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.

  PMID: 39088370 RESULT

• 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.

  PMID: 41130873 RESULT

Central Study Contacts

Zeynep GÜRKAN, PhD

CONTACT

+905389786500; zeynepgurkan@yyu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Saliva samples will be labeled with unique participant codes that do not reveal group assignment. Laboratory personnel performing the salivary cortisol analyses will remain blinded to the participants' allocation until the analyses are completed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, PhD

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the white noise intervention group or the routine care control group. Each participant will remain in the assigned group throughout the study, with no crossover between groups.

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 2, 2026
• Study Start: September 27, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share