Back to resultsThe Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety
Primary Purpose
Maternal Distress (During Labor), Anxiety
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Informative video
Sponsored by
About this trial
This is an interventional supportive care trial for Maternal Distress (During Labor) focused on measuring Cesarean delivery, Anxiety, Informative-video
Eligibility Criteria
Inclusion Criteria:
- Hebrew speaking
- Informed consent
- First cesarean delivery
- Non emergent elective CD
Exclusion Criteria:
- Non Hebrew speaking
- Refuse to participate
- Emergency CD
Sites / Locations
- Haemek Medical Center
- Asuta Medical Center
- Rambam Medical Center
- Wolfson medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Study group- video+questionnaire
Control group- questionnaire only
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The State-Trait Anxiety Inventory STAI:Y-1
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 to evaluate the women experience and satisfaction
Full Information
NCT ID
NCT04176107
First Posted
October 22, 2019
Last Updated
February 28, 2021
Sponsor
Wolfson Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04176107
Brief Title
The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety
Official Title
The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety and Peripartum Satisfaction- a Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Distress (During Labor), Anxiety
Keywords
Cesarean delivery, Anxiety, Informative-video
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group- video+questionnaire
Arm Type
Other
Arm Description
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).
Arm Title
Control group- questionnaire only
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Informative video
Intervention Description
Exposure to informative video before cesarean delivery
Primary Outcome Measure Information:
Title
The State-Trait Anxiety Inventory STAI:Y-1
Description
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.
Time Frame
Baseline (Questionnaire filled by the patient Before operation)
Secondary Outcome Measure Information:
Title
The State-Trait Anxiety Inventory STAI:Y-1
Description
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.
Time Frame
Questionnaire filled by the patient at admission- 1 day before operation
Title
Childbirth experience questionnaire (CEQ)
Description
Questionnaire to evaluate the women experience and satisfaction
Time Frame
Questionnaire filled by the patient at 1 day after the delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Hebrew speaking
Informed consent
First cesarean delivery
Non emergent elective CD
Exclusion Criteria:
Non Hebrew speaking
Refuse to participate
Emergency CD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hadas miremberg, MD
Organizational Affiliation
Wolfson Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haemek Medical Center
City
Afula
Country
Israel
Facility Name
Asuta Medical Center
City
Asdod
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Wolfson medical center
City
Holon
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35240345
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety
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