The Effect of Exposure to an Informative Video on Maternal Anxiety

The Effect of Exposure to an Informative Video Regarding Possible Obstetric Emergencies on Maternal Anxiety and Peripartum Satisfaction- A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Anxiety; Labor Pain; Patient Satisfaction
• Intervention / Treatment: Other: Informative Video group

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

• Study Type: Interventional
• Enrollment (Anticipated): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Holon, Israel
    • Recruiting
    • Wolfson Medical Center
    • Contact: Hadas Miremberg, MD; Phone Number: 972526741740; Email: dasile2@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Informative video arm; 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	Other: Informative Video group; Informative Video group before labor in nulliparous women
No Intervention: control arm; no intervention. All patients will answer the State-Trait Anxiety Inventory (STAI) before and after delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The State-Trait Anxiety Inventory score in delivery room	STAI questionnaire before and after delivery room	1 hour

Collaborators and Investigators

• Sponsor: Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 30, 2020

Study Registration Dates

• First Submitted: September 1, 2019
• First Submitted That Met QC Criteria: October 20, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 20, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Anxiety Disorders; Labor Pain
• Other Study ID Numbers: 0093-19-WOMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No