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

Not Applicable

Completed

• Conditions: Anxiety; Maternal Distress (During Labor)
• Interventions: Behavioral: Informative video

• Registration Number: NCT04176107
• Lead Sponsor: Wolfson Medical Center

Brief 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.

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 Timeline

• Study Start: 2019-08-26
• Study First Submitted: 2019-10-22
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-25
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Last Update Submitted: 2021-02-28
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group- video+questionnaire	Informative video	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).

Primary Outcome Measures

Name	Time	Method
The State-Trait Anxiety Inventory STAI:Y-1	Baseline (Questionnaire filled by the patient Before operation)	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.

Secondary Outcome Measures

Name	Time	Method
The State-Trait Anxiety Inventory STAI:Y-1	Questionnaire filled by the patient at admission- 1 day before operation	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.
Childbirth experience questionnaire (CEQ)	Questionnaire filled by the patient at 1 day after the delivery	Questionnaire to evaluate the women experience and satisfaction

Trial Locations

Locations (4)

Asuta Medical Center; 🇮🇱 Asdod, Israel

Wolfson medical center; 🇮🇱 Holon, Israel

Haemek Medical Center; 🇮🇱 Afula, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel