Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07798934

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zeynep GÜRKAN, PhD

CONTACT

[email protected]

+905389786500

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Collaborators

  • Van Yüzüncü Yıl University Scientific Research Projects Coordination Unit

Registry information

Official study title

The Effect of White Noise on Salivary Cortisol Levels and Vital Signs in Patients Undergoing Gastroscopy: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.