The Effect of Exposure to an Informative Video on Materna... | NCT04136301

Studies
The Effect of Exposure to an Informative Video on Maternal Anxiety

NCT04136301

Sponsor

Wolfson Medical Center

Status

Unknown status

Last Update Posted

Oct 23, 2019Actual

Enrollment

152Estimated

Phase

Not Applicable

Conditions

Anxiety
Labor Pain
Patient Satisfaction

Interventions

Informative Video group

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Estimated

Primary Completion Date

Aug 1, 2020Estimated

Completion Date

Aug 30, 2020Estimated

First Submitted Date

Sep 1, 2019

First Submission Date that Met QC Criteria

Oct 20, 2019

First Posted Date

Oct 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 20, 2019

Last Update Posted Date

Oct 23, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

152Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Informative video arm	Experimental	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
control arm	No Intervention	no intervention. All patients will answer the State-Trait Anxiety Inventory (STAI) before and after delivery.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Informative Video group	Other	Informative Video group before labor in nulliparous women	Informative video arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Pregnant women

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wolfson medical center	Recruiting	Holon			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D048949	Labor Pain
D017060	Patient Satisfaction

Ancestor Terms

ID	Term
D001523	Mental Disorders
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided