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NCT04176107 Clinical Trial

The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety

Anxiety Clinical Trial

Official title:
The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety and Peripartum Satisfaction- a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04176107
Other study ID # 0092-19-WOMC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 26, 2019
Est. completion date December 1, 2020

Study information
Verified date November 2019
Source Wolfson Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

A multi-center randomized control trial the will examine the effect of exposure to informative video before cesarean delivery on maternal anxiety and satisfaction

Recruitment information / eligibility
Status Completed
Enrollment 126
Est. completion date December 1, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Hebrew speaking - Informed consent - First cesarean delivery - Non emergent elective CD Exclusion Criteria: - Non Hebrew speaking - Refuse to participate - Emergency CD

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Informative video
Exposure to informative video before cesarean delivery

Locations
Country Name City State
Israel Haemek Medical Center Afula
Israel Asuta Medical Center Asdod
Israel Rambam Medical Center Haifa
Israel Wolfson medical center Holon

Sponsors (1)
Lead Sponsor Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary The State-Trait Anxiety Inventory STAI:Y-1 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 The State-Trait Anxiety Inventory STAI:Y-1 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
Secondary Childbirth experience questionnaire (CEQ) Questionnaire to evaluate the women experience and satisfaction Questionnaire filled by the patient at 1 day after the delivery
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