NCT03109054

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

2 months

First QC Date

March 28, 2017

Last Update Submit

April 5, 2017

Conditions

Anxiety DisordersMelatonin

Keywords

MelatoninAnxiety

Outcome Measures

Primary Outcomes (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.

    preoperative and 24. hour after postoperative

Secondary Outcomes (1)

  • S-Anxiety (State-Trait Anxiety Inventory Test

    preoperative and 24. hour after postoperative

Study Arms (2)

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/)

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/)

Diagnostic Test: State-Trait Anxiety Inventory Test

Interventions

State-Trait Anxiety Inventory TestDIAGNOSTIC_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
High Anxiety LevelLow Anxiety Level

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • American Society of Anesthesiologists (ASA) 3-4 status, aged between 18-65 years who are scheduled to undergo bariatric surgery.

You may not qualify if:

  • Patients with cardiovascular and pulmonary disease, those with ASA III-IV and propofol, fentanyl, remifentanil and rocuronium allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu university

Malatya, Malatya, 044100, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 28244626RESULT

  • Hansen MV. Chronobiology, cognitive function and depressive symptoms in surgical patients. Dan Med J. 2014 Sep;61(9):B4914.

    PMID: 25186550RESULT

  • Edwards-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.

    PMID: 25084797RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, M.D.

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 12, 2017

Study Start

March 15, 2017

Primary Completion

May 15, 2017

Study Completion

June 15, 2017

Last Updated

April 12, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

no a plan

Locations

TU(1)