Anxiety DisordersNCT03109054
Endogenous Melatonin Level and Pre- Postoperative Anxiety in Bariatric Surgery Patients.
An observational study of Anxiety Disorders and Melatonin, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders, Melatonin
- What is being tested?
- State-Trait Anxiety Inventory Test
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2017to 15 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- American Society of Anesthesiologists (ASA) 3-4 status, aged between 18-65 years who are scheduled to undergo bariatric surgery.
Who cannot join
- Patients with cardiovascular and pulmonary disease, those with ASA III-IV and propofol, fentanyl, remifentanil and rocuronium allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Endogenous Melatonin Level in Preoperative and Postoperative Anxiety in Bariatric Surgery Patients
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Anxiety Disorders, Melatonin
- Being tested
- State-Trait Anxiety Inventory Test
- Keywords
- Melatonin, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
State-Trait Anxiety Inventory TestDiagnostic test
Also called STAI FORM TX-1
All patients will take a State-Trait Anxiety Inventory Test. After the test patients will enroll low or high anxiety level.
| Study group | Role | What they receive |
|---|---|---|
| Low Anxiety Level | 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/) Receives: Diagnostic Test: State-Trait Anxiety Inventory Test | |
| High Anxiety Level | 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/) Receives: Diagnostic Test: State-Trait Anxiety Inventory Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: preoperative and 24. hour after postoperative
Secondary outcomes (1)
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.
Measured: preoperative and 24. hour after postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start15 Mar 2017
- Primary completion15 May 2017 (estimated)
- Study completion15 Jun 2017 (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 Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ali Erdoğan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109054
- Sponsor's protocol ID
- MAE4
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2017
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no a plan
Publications
Cardoso L, Rodrigues D, Gomes L, Carrilho F. Short- and long-term mortality after bariatric surgery: A systematic review and meta-analysis. Diabetes Obes Metab. 2017 Sep;19(9):1223-1232. doi: 10.1111/dom.12922. Epub 2017 May 31.
PubMed 28244626Hansen MV. Chronobiology, cognitive function and depressive symptoms in surgical patients. Dan Med J. 2014 Sep;61(9):B4914.
PubMed 25186550Edwards-Hampton SA, Madan A, Wedin S, Borckardt JJ, Crowley N, Byrne KT. A closer look at the nature of anxiety in weight loss surgery candidates. Int J Psychiatry Med. 2014;47(2):105-13. doi: 10.2190/PM.47.2.b.
PubMed 25084797
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endogenous Melatonin Level in Preoperative and Postoperative Anxiety in Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT03109054
- Acronym / sponsor ID
- MAE4
- Conditions
- Anxiety Disorders, Melatonin
- Keywords
- Melatonin, Anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 May 2017 (estimated)
- Study completion
- 15 Jun 2017 (estimated)
- First posted
- 12 Apr 2017 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Anxiety Level | – | Diagnostic Test: State-Trait Anxiety Inventory TestThe 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/) |
| High Anxiety Level | – | Diagnostic Test: State-Trait Anxiety Inventory TestThe 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/) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) 3-4 status, aged between 18-65 years who are scheduled to undergo bariatric surgery.
Key exclusion criteria (1 listed)
- Patients with cardiovascular and pulmonary disease, those with ASA III-IV and propofol, fentanyl, remifentanil and rocuronium allergy.
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 |
|---|---|---|
| State-Trait Anxiety Inventory TestAlso: STAI FORM TX-1All patients will take a State-Trait Anxiety Inventory Test. After the test patients will enroll low or high anxiety level. | Diagnostic test | High Anxiety Level, Low Anxiety Level |
Primary outcome
change in melatonin levels
Time frame: preoperative and 24. hour after postoperative
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.
1 secondary outcome
S-Anxiety (State-Trait Anxiety Inventory Test
Time frame: preoperative and 24. hour after postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Results publication: PubMed 28244626Cardoso L, Rodrigues D, Gomes L, Carrilho F. Short- and long-term mortality after bariatric surgery: A systematic review and meta-analysis. Diabetes Obes Metab. 2017 Sep;19(9):1223-1232. doi: 10.1111/dom.12922. Epub 2017 May 31.
- Results publication: PubMed 25186550Hansen MV. Chronobiology, cognitive function and depressive symptoms in surgical patients. Dan Med J. 2014 Sep;61(9):B4914.
- Results publication: PubMed 25084797Edwards-Hampton SA, Madan A, Wedin S, Borckardt JJ, Crowley N, Byrne KT. A closer look at the nature of anxiety in weight loss surgery candidates. Int J Psychiatry Med. 2014;47(2):105-13. doi: 10.2190/PM.47.2.b.
- Individual participant dataSharing planned: No. no a plan
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety Disorders and Melatonin, run by Inonu University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in melatonin levels (time frame: preoperative and 24. hour after postoperative). 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 NCT03109054, 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 12 Apr 2017.