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: Completed
• Conditions: Anxiety; Maternal Distress (During Labor)
• Intervention / Treatment: Behavioral: Informative video

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

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

Number of Arms

2

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).	Behavioral: Informative video; 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	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	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)	Questionnaire to evaluate the women experience and satisfaction	Questionnaire filled by the patient at 1 day after the delivery

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Investigators: Principal Investigator: hadas miremberg, MD, Wolfson Medical Center

Publications and helpful links

General Publications

• Miremberg H, Yirmiya K, Vinter D, Lauterbach R, Yefet E, Nassra R, Paz YG, Hagege R, Weiner E. An informative video before planned cesarean delivery and maternal anxiety-a multicenter randomized controlled trial. Am J Obstet Gynecol MFM. 2022 May;4(3):100604. doi: 10.1016/j.ajogmf.2022.100604. Epub 2022 Feb 28.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 28, 2021
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Anxiety; Cesarean delivery; Informative-video
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 0092-19-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