Physiological Stress, Procedural Anxiety
Conditions
Keywords
White Noise, Gastroscopy, Salivary Cortisol, Vital Signs, Procedural Anxiety, Physiological Stress, Nursing Intervention, Randomized Controlled Trial
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.
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.
Interventions
BEHAVIORALWhite Noise
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.
Sponsors
Yuzuncu Yil University
Van Yüzüncü Yıl University Scientific Research Projects Coordination Unit
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Salivary Cortisol Level | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | 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. |
| Change in Diastolic Blood Pressure | 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. |
| Change in Heart Rate | 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. |
| Change in Respiratory Rate | 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. |
| Change in Peripheral Oxygen Saturation | 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. |
| Change in Patient-Reported Anxiety | 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. |
| Change in Patient-Reported Pain | 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. |
Contacts
CONTACTZeynep GÜRKAN, PhD
Outcome results
None listed