The Effect of Pre-operative Videotape Before a Planned Cesarean Section on Anxiety Level
NCT ID: NCT04177966
Last Updated: 2023-03-01
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
NA
100 participants
INTERVENTIONAL
2020-07-29
2023-12-31
Brief Summary
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the patients will be assigned into two groups - intervention and control. In the intervention group - the day before surgery the women will watch a pre-prepared video showing in detail the course of events around the operation.
the level of anxiety, pain level and Intake of Analgesics will be compared between the two groups
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Detailed Description
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The movie will be shown to the patient by one of the study investigators. In the control group - women will receive general information about the surgery as part of the routine informed consent process, without watching a pre- prepared film.
the level of anxiety, pain level and Intake of Analgesics will be compared between the two groups
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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women watching the pre-prepared video before surgery
Women undergoing primary elective cesarean surgery at term The day before surgery the women will watch a pre-prepared video, approximately 10 minutes in length, showing in detail the course of events around the operation
pre-prepared video describing the cesarean surgery
a pre-prepared video, approximately 10 minutes in length, showing in detail the course of events around the operation - from the woman's perspective - from the time they were admitted to the department, preparation for surgery, entrance to the operating r
women not watching the pre-prepared video before surgery
Women undergoing primary elective cesarean surgery at term Women will receive general information about the surgery as part of informed consent, without watching a pre- prepared film.
general information
In the control group - women will receive general information about the surgery as part of informed consent, without watching a pre-prepared film.
Interventions
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pre-prepared video describing the cesarean surgery
a pre-prepared video, approximately 10 minutes in length, showing in detail the course of events around the operation - from the woman's perspective - from the time they were admitted to the department, preparation for surgery, entrance to the operating r
general information
In the control group - women will receive general information about the surgery as part of informed consent, without watching a pre-prepared film.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Women with anxiety disorders
* Women with comorbidity that might alter cortisol and catecholamine excretion,
* Women with comorbidity associated with severe pain that might distort pain ratings
* Women with psychiatric comorbidity that might reduce the ability to understand the videotape and questionnaires
* Women who consume any medication that might affect urinary excretion of cortisol
* Women undergoing cesarean surgery due to obstetric complication (gestational hypertension, pre-eclampsia, gestational diabetes mellitus)
18 Years
FEMALE
Yes
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Eyal Rom, MD
Principal Investigator
Principal Investigators
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eyal rom, MD
Role: PRINCIPAL_INVESTIGATOR
Emek Medical Center
Locations
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Haemek Medical Center
Afula, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EMC-19-130
Identifier Type: -
Identifier Source: org_study_id
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