- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04176107
The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety
The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety and Peripartum Satisfaction- a Randomized Control Trial
The incidence of cesarean deliveries (CD) worldwide is increasing, around 30% in United States. Although very common surgery women undergoing non emergent CD still experience fear and anxiety. It is known that increased levels of stress can negatively affect pain perception and the usage of analgesics postoperatively as well as lactation.
this present study investigate the effect of exposure to informative video before cesarean delivery on maternal anxiety.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Afula, Israel
- HaEmek Medical Center
-
Asdod, Israel
- Asuta Medical Center
-
Haifa, Israel
- Rambam Medical Center
-
Holon, Israel
- Wolfson Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hebrew speaking
- Informed consent
- First cesarean delivery
- Non emergent elective CD
Exclusion Criteria:
- Non Hebrew speaking
- Refuse to participate
- Emergency CD
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Study group- video+questionnaire
The study group will be exposed to a video at admission to an elective cesarean delivery. The video will have information regarding the admission, pre-operation preparation and post- operation recovery. All patients will answer a questionnaire at admission, before surgery and 24 hours later. the questionnaires will evaluate the impact of exposure to informative video before caesarean delivery on anxiety and stress measured by State-Trait Anxiety Inventory (STAI). |
Exposure to informative video before cesarean delivery
|
No Intervention: Control group- questionnaire only
All patients will answer a questionnaire at admission, before surgery and 24 hours later.
the questionnaires will evaluate anxiety and stress measured by State-Trait Anxiety Inventory (STAI) without intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The State-Trait Anxiety Inventory STAI:Y-1
Time Frame: Baseline (Questionnaire filled by the patient Before operation)
|
Psychological questionnaire to assess stress and anxiety-The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 20 questions on a self-report basis.
Higher scores are positively correlated with higher levels of anxiety.
|
Baseline (Questionnaire filled by the patient Before operation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The State-Trait Anxiety Inventory STAI:Y-1
Time Frame: Questionnaire filled by the patient at admission- 1 day before operation
|
Psychological questionnaire to assess stress and anxietyhe State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 20 questions on a self-report basis.
Higher scores are positively correlated with higher levels of anxiety.
|
Questionnaire filled by the patient at admission- 1 day before operation
|
Childbirth experience questionnaire (CEQ)
Time Frame: Questionnaire filled by the patient at 1 day after the delivery
|
Questionnaire to evaluate the women experience and satisfaction
|
Questionnaire filled by the patient at 1 day after the delivery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: hadas miremberg, MD, Wolfson Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0092-19-WOMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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