NCT04136301

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 1, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

9 months

First QC Date

September 1, 2019

Last Update Submit

October 20, 2019

Conditions

AnxietyLabor PainPatient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • The State-Trait Anxiety Inventory score in delivery room

    STAI questionnaire before and after delivery room

    1 hour

Study Arms (2)

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

Informative Video groupOTHER

Informative Video group before labor in nulliparous women

Informative video arm

Eligibility Criteria

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

You may qualify if:

  • above 18 years of age Nulliparus women Informed consent Reads and understand Hebrew \>37 weeks of gestation

You may not qualify if:

  • Refuse to participate Contraindications for vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson medical center

Holon, Israel

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersLabor PainPatient Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2019

First Posted

October 23, 2019

Study Start

November 1, 2019

Primary Completion

August 1, 2020

Study Completion

August 30, 2020

Last Updated

October 23, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)