The Effect of Exposure to an Informative Video on Maternal Anxiety
Primary Purpose
Anxiety, Labor Pain, Patient Satisfaction
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Informative Video group
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
above 18 years of age Nulliparus women Informed consent Reads and understand Hebrew >37 weeks of gestation
Exclusion Criteria:
Refuse to participate Contraindications for vaginal delivery
Sites / Locations
- Wolfson medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Informative video arm
control arm
Arm Description
Nuliparus women admitted to an induction will be exposed to informative video with data regarding labor and possible obstetric emergencies such as cesarean delivery. All patients will answer the State-Trait Anxiety Inventory (STAI) before and after intervention
no intervention. All patients will answer the State-Trait Anxiety Inventory (STAI) before and after delivery.
Outcomes
Primary Outcome Measures
The State-Trait Anxiety Inventory score in delivery room
STAI questionnaire before and after delivery room
Secondary Outcome Measures
Full Information
NCT ID
NCT04136301
First Posted
September 1, 2019
Last Updated
October 20, 2019
Sponsor
Wolfson Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04136301
Brief Title
The Effect of Exposure to an Informative Video on Maternal Anxiety
Official Title
The Effect of Exposure to an Informative Video Regarding Possible Obstetric Emergencies on Maternal Anxiety and Peripartum Satisfaction- A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Anticipated)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
August 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stress and anxiety during childbirth have negative consequence on both mother and fetus. Previous studies have learned the effect of several intervention to reduce anxiety during labor- such as music and foot reflexology. Nevertheless, data for informative video before labor for reducing stress and anxiety are sparse. The present study aimed to review and determine the effect of informative video on anxiety, pain and outcomes of the labor in primigravida women.
Detailed Description
A randomized control trial studying the effect of exposure to an informative video regarding labor and possible obstetrics emergencies on maternal anxiety and postpartum satisfaction
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Labor Pain, Patient Satisfaction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Informative video arm
Arm Type
Experimental
Arm Description
Nuliparus women admitted to an induction will be exposed to informative video with data regarding labor and possible obstetric emergencies such as cesarean delivery.
All patients will answer the State-Trait Anxiety Inventory (STAI) before and after intervention
Arm Title
control arm
Arm Type
No Intervention
Arm Description
no intervention. All patients will answer the State-Trait Anxiety Inventory (STAI) before and after delivery.
Intervention Type
Other
Intervention Name(s)
Informative Video group
Intervention Description
Informative Video group before labor in nulliparous women
Primary Outcome Measure Information:
Title
The State-Trait Anxiety Inventory score in delivery room
Description
STAI questionnaire before and after delivery room
Time Frame
1 hour
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
above 18 years of age Nulliparus women Informed consent Reads and understand Hebrew >37 weeks of gestation
Exclusion Criteria:
Refuse to participate Contraindications for vaginal delivery
Facility Information:
Facility Name
Wolfson medical center
City
Holon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hadas Miremberg, MD
Phone
972526741740
Email
dasile2@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Exposure to an Informative Video on Maternal Anxiety
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