NCT04176107

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 2, 2021

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

October 22, 2019

Last Update Submit

February 28, 2021

Conditions

Maternal Distress (During Labor)Anxiety

Keywords

Cesarean deliveryAnxietyInformative-video

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The State-Trait Anxiety Inventory STAI:Y-1

    Questionnaire filled by the patient at admission- 1 day before operation

  • Childbirth experience questionnaire (CEQ)

    Questionnaire filled by the patient at 1 day after the delivery

Study Arms (2)

Study group- video+questionnaire

OTHER

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

Control group- questionnaire only

NO INTERVENTION

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.

Interventions

Informative videoBEHAVIORAL

Exposure to informative video before cesarean delivery

Study group- video+questionnaire

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Non Hebrew speaking
  • Refuse to participate
  • Emergency CD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Haemek Medical Center

Afula, Israel

Location

Asuta Medical Center

Ashdod, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Wolfson medical center

Holon, Israel

Location

Related Publications (1)

  • 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.

    PMID: 35240345DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • hadas miremberg, MD

    Wolfson Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2019

First Posted

November 25, 2019

Study Start

August 26, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 2, 2021

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(4)