An observational study in Anxiety Disorders and Melatonin, sponsored by Inonu University. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-12.
Sponsored by Inonu University · Observational
Bariatric surgical procedures are associated with low short-term mortality and may be associated with long-term reductions in all-cause, cardiovascular, and cancer-related mortality. This surgeries are major surgeries include risk of mortality still.
Different level anxiety that can define as fear or worry can be seen in 60%-80% of patients scheduled surgery. Anxiety levels; may vary on age, gender, type of operation, previous experience of anesthesia and surgery and way of hospitalization. Preoperative anxiety affects negatively the surgery, the anesthesia and postoperative recovery.
Melatonin is a hormone secreted from the pineal gland. The circadian rhythm of melatonin changes according to age and it's production decreases with older ages. Melatonin is an antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative, analgesic and has a preventive effect of delirium in intensive care. Irregularity of melatonin secretion causes a sleep irregularities, psychosis in intensive care unit and some behavioral disorder. It has been demonstrated that oral exogen administration of melatonin was effective on preoperative anxiety.
The aim of this study was to determine the relationship between endogenous melatonin levels and anxiety levels in patients with bariatric surgery.
Bariatric surgical procedures, including gastric bypass, vertical sleeve gastrectomy, and biliopancreatic diversion, are the most effective and durable treatments for obesity. Bariatric surgery provides long-term benefit for patients with diabetes, fatty liver disease, and other metabolic disorders, through both weight loss-dependent and -independent mechanisms.
Bariatric surgery is associated with low short-term mortality and may be associated with long-term reductions in all-cause, cardiovascular, and cancer-related mortality. This surgeries are major surgeries include risk of mortality still.
Different level anxiety that can define as fear or worry can be seen in 60%-80% of patients scheduled surgery. Anxiety levels; may vary on age, gender, type of operation, previous experience of anesthesia and surgery and way of hospitalization. Preoperative anxiety affects negatively the surgery, the anesthesia and postoperative recovery. It may cause the pathophysiological response as hypertension and arrhythmia even refusal the surgery is planned. Also the anesthetic requirements and the risk "awareness" during the operation may increase. Patients with high level anxiety have more postoperative pain symptoms too. Therefore determination of the causes and prevention of anxiety is important.
Melatonin is a hormone secreted from the pineal gland, also known as the pineal gland. It's production is stimulated by darkness, independent of sleep, and is inhibited by exposure to light and proved endocrine rhythms. It shows a daily biorhythm. The circadian rhythm of melatonin changes according to age and it's production decreases with older ages. Melatonin level can be measured in the blood and in urine collected for 24 hours. Melatonin is an antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative, analgesic and has a preventive effect of delirium in intensive care. Irregularity of melatonin secretion causes a sleep irregularities, psychosis in intensive care unit and some behavioral disorder. It has been demonstrated that oral exogen administration of melatonin was effective on preoperative anxiety.
The aim of this study was to determine the relationship between endogenous melatonin levels and anxiety levels in patients with bariatric surgery.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's planned enrollment of 50 is below the median of 148 across 630 observational studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Inonu University is the lead sponsor of 385 studies on the registry; 90 are open to participants now.
Counted across the registry records on this site, refreshed daily.
50 patients of American Society of Anesthesiologists (ASA) 1-2 status, aged between 18-65 years who are scheduled to undergo bariatric surgery, will be included in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
American Society of Anesthesiologists (ASA) 3-4 status, aged between 18-65 years who are scheduled to undergo bariatric surgery.
Exclusion Criteria:
Patients with cardiovascular and pulmonary disease, those with ASA III-IV and propofol, fentanyl, remifentanil and rocuronium allergy.
The patients had low anxiety levels. Anxiety levels will determine with S-Anxiety TX-1 (State-Trait Anxiety Inventory Test:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3879951/)
Diagnostic Test: State-Trait Anxiety Inventory Test
The patients had high anxiety levels. Anxiety levels will determine with S-Anxiety (State-Trait Anxiety Inventory Test: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3879951/)
Diagnostic Test: State-Trait Anxiety Inventory Test
All patients will take a State-Trait Anxiety Inventory Test. After the test patients will enroll low or high anxiety level.
Also known as: STAI FORM TX-1
change in melatonin levels
Melatonin is a hormone secreted from the pineal gland. It shows a daily biorhythm. The circadian rhythm of melatonin changes according to age and it's production decreases with older ages. Melatonin level can be measured in the blood and in urine collected for 24 hours.
Time frame: preoperative and 24. hour after postoperative
S-Anxiety (State-Trait Anxiety Inventory Test
Anxiety levels; may vary on age, gender, type of operation, previous experience of anesthesia and surgery and way of hospitalization.
Time frame: preoperative and 24. hour after postoperative
Plan to share: No — no a plan
Started Mar 2017 (actual). Primary completion is estimated for May 2017, 2 months after the start.
Of 262 non-industry observational studies under Anxiety Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 52. This study's planned 2 months is below that.
Counting every sponsor, half of 284 studies reached it within 18 months; a quarter within 6 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.