The Effect of Preoperative Anxiety, on Gastric Antrum Size in Women Undergoing in Vitro Fertilization
NCT ID: NCT04833530
Last Updated: 2021-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2021-04-01
2022-12-01
Brief Summary
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There have been a few factors which are thought to increase gastric size. Delayed gastric emptying such as caused by gastroparesis in Diabetes Mellitus is an example. Certain surgeries also cause gastroparesis. Other preoperative factors including pain, preoperative anxiety, and blood levels of estradiol or progesterone are less well studied.
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Detailed Description
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Upon signed informed consent, women will be asked to rank their anxiety level on a scale of 0-10 (Verbal Numeric Anxiety Score). This scale has been used for previous studies to assess anxiety (Orbach-Zinger, Danon)
In the operating room, a gastric ultrasound will be performed in the supine position and the antral cross sectional area will be measured. This study is purely observational, the gastric ultrasound assessment is non-invasive and will not cause any adverse effects or discomfort to the patient. Participation in the study will not affect clinical management in any way.
Each one of the ultrasound assessments will be performed by one of the study's' investigators.
Anesthesia will be induced in standard procedure and positive pressure will be instituted according to the standard protocol accepted in our hospital.
At the end of the procedure, the gastric ultrasound circumference will be measured again.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Woman undergoing an gastric ultrasound assessment.
Woman undergoing general anesthesia for oocyte retrieval during in vitro fertilization, will undergo an gastric ultrasound assessment.
Gastric Ultrasound
In the operating room, a gastric ultrasound will be performed in the supine position and the antral cross sectional area will be measured. Anesthesia will be induced in standard procedure and positive pressure will be instituted according to the standard protocol accepted in our hospital.
At the end of the procedure, the gastric ultrasound circumference will be measured again.
Interventions
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Gastric Ultrasound
In the operating room, a gastric ultrasound will be performed in the supine position and the antral cross sectional area will be measured. Anesthesia will be induced in standard procedure and positive pressure will be instituted according to the standard protocol accepted in our hospital.
At the end of the procedure, the gastric ultrasound circumference will be measured again.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Women with diabetes
3. Women who have previously undergone gastric surgery
4. Women with language barriers.
18 Years
120 Years
FEMALE
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Sharon Orbach-zinger
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Beilinson hospital
Petach Tikvah, , Israel
Countries
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Central Contacts
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References
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Azem K, Orbach-Zinger S, Heesen P, Finkelstein A, Eidelman LA, Shufaro Y, Arzola C. The effect of preoperative anxiety and ovarian stimulation on gastric antrum size: a prospective observational study. J Psychosom Obstet Gynaecol. 2023 Dec;44(1):2170226. doi: 10.1080/0167482X.2023.2170226.
Other Identifiers
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0010-21
Identifier Type: -
Identifier Source: org_study_id
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