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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
Wolfson Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
September 1, 2019
Last Updated
October 20, 2019
Sponsor
Wolfson Medical Center
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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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