Effect of White Noise on Salivary Cortisol and Vital Signs During Gastroscopy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYuzuncu Yil University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
White Noise
BehavioralWhite 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: White Noise Intervention GroupExperimental treatment 1 intervention
Group B: Routine Care Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Perioperative and PeriproceduralSecondary outcomes
1
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.
Time frame
Perioperative and Periprocedural2
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.
Time frame
Perioperative and Periprocedural3
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.
Time frame
Perioperative and Periprocedural4
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.
Time frame
Perioperative and PeriproceduralLocations
Sponsors and contacts
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Yuzuncu Yil University
Lead sponsor
Van Yüzüncü Yıl University Scientific Research Projects Coordination Unit
Collaborator
Source ClinicalTrials.gov
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