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

NCT ID: NCT04176107

Last Updated: 2021-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-26

Study Completion Date

2020-12-01

Brief Summary

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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

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A multi-center randomized control trial the will examine the effect of exposure to informative video before cesarean delivery on maternal anxiety and satisfaction

Conditions

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Maternal Distress (During Labor) Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type OTHER

Informative video

Intervention Type BEHAVIORAL

Exposure to informative video before cesarean delivery

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Informative video

Exposure to informative video before cesarean delivery

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Hebrew speaking
* Informed consent
* First cesarean delivery
* Non emergent elective CD

Exclusion Criteria

* Non Hebrew speaking
* Refuse to participate
* Emergency CD
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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hadas miremberg, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Locations

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Haemek Medical Center

Afula, , Israel

Site Status

Asuta Medical Center

Ashdod, , Israel

Site Status

Rambam Medical Center

Haifa, , Israel

Site Status

Wolfson medical center

Holon, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 35240345 (View on PubMed)

Other Identifiers

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0092-19-WOMC

Identifier Type: -

Identifier Source: org_study_id

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