Procedural AnxietyNCT07798934
Effect of White Noise on Salivary Cortisol and Vital Signs During Gastroscopy
A study testing White Noise in people with Procedural Anxiety and Physiological Stress, run by Yuzuncu Yil University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Anxiety, Physiological Stress
- What is being tested?
- White Noise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 27 Sep 2026to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of White Noise on Salivary Cortisol Levels and Vital Signs in Patients Undergoing Gastroscopy: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Procedural Anxiety, Physiological Stress
- Being tested
- White Noise
- Keywords
- White Noise, Gastroscopy, Salivary Cortisol, Vital Signs, Procedural Anxiety, Physiological Stress, Nursing Intervention, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White NoiseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative and Periprocedural
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Perioperative and Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start27 Sep 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Procedural AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Gürkan, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798934
- Sponsor's protocol ID
- 2026/07-07
- Other IDs
- 13402
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32316918Demirci 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.
PubMed 39088370Genc 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.
PubMed 41130873
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of White Noise on Salivary Cortisol Levels and Vital Signs in Patients Undergoing Gastroscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07798934
- Acronym / sponsor ID
- 2026/07-07
- Conditions
- Procedural Anxiety, Physiological Stress
- Keywords
- White Noise, Gastroscopy, Salivary Cortisol, Vital Signs, Procedural Anxiety, Physiological Stress, Nursing Intervention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 27 Sep 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| White Noise Intervention Group | Experimental | Behavioral: White NoiseParticipants 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. |
| Routine Care Control Group | No intervention | –Participants will receive routine care provided by the endoscopy unit without any auditory intervention during the gastroscopy procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White NoiseWhite 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. | Behavioural | White Noise Intervention Group |
Primary outcome
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.
7 secondary outcomes
Change in Systolic Blood Pressure
Time frame: Perioperative and Periprocedural
Change in Diastolic Blood Pressure
Time frame: Perioperative and Periprocedural
Change in Heart Rate
Time frame: Perioperative and Periprocedural
Change in Respiratory Rate
Time frame: Perioperative and Periprocedural
Change in Peripheral Oxygen Saturation
Time frame: Perioperative and Periprocedural
Change in Patient-Reported Anxiety
Time frame: Perioperative and Periprocedural
Change in Patient-Reported Pain
Time frame: Perioperative and Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Results publication: PubMed 32316918Sogabe 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.
- Results publication: PubMed 39088370Demirci 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.
- Results publication: PubMed 41130873Genc 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing White Noise in people with Procedural Anxiety and Physiological Stress, run by Yuzuncu Yil University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep GÜRKAN, PhD (+905389786500, zeynepgurkan@yyu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Salivary Cortisol Level (time frame: Perioperative and Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07798934, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.