Back to resultsThe Effect of Exposure to an Informative Video About Amniocentesis Before the Procedure on Maternal Anxiety
Primary Purpose
Pregnancy Related, Anxiety in Pregnancy, Amniocentesis Affecting Fetus or Newborn
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Informative video
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy Related focused on measuring explanatory video, anxiety reduction, amniocentesis, pregnancy
Eligibility Criteria
Inclusion Criteria:
- Women who come for amniocentesis in the Edith Wolfson Medical Center
- Women who sign a consent form to enroll to the study.
Exclusion Criteria:
- Women under 18 years of age.
- Women who do not speak Hebrew
Sites / Locations
- Edith Wolfson Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Informative video
No video
Arm Description
The research group will be exposed to an informative instructional film before the procedure.
The control group will undergo amniocentesis with information given as accepted by standard-of-care.
Outcomes
Primary Outcome Measures
Assessment of change in anxiety levels between before and after undergoing the amniocentesis
Women recruited to the study will answer the Spielberger's state-trait anxiety inventory questionnaire- a validated questionnaire for assessing anxiety which includes 20 statements expressing different states of anxiety. The patients will be asked to rate to what extent they currently relate to the statement written on a scale of 1 to 4 (1- does not agree at all and 4- strongly agrees). The final score in each questionnaire is obtained by summing the scores of each statement, while the scores of positive statements reflecting anxiety-free behavior will be reversely summed. Higher scores indicate higher level of anxiety.
Secondary Outcome Measures
Intensity of pain, discomfort, satisfaction with the video and satisfaction in general
These parameters will be measured using the item visual analog scales 11 questionnaire containing questions reflecting pain, discomfort and satisfaction levels. Each statement scores between 0-10 as a reflection of the patients' identification with the statement- each statement reflecting different aspects of the patients' experience:
question 1- pain during the procedure question 2- pain 10 minutes after the procedure question 3- general unpleasantness question 4- anxiety during procedure question 5- satisfaction with information about procedure question 6- overall satisfaction with treatment question 7- level of discomfort as a result of informative video prior to the amniocentesis question 8- level of anxiety caused by watching the informative video question 9-importance of informative video for understanding the amniocentesis procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05463549
Brief Title
The Effect of Exposure to an Informative Video About Amniocentesis Before the Procedure on Maternal Anxiety
Official Title
The Effect of Exposure to an Informative Video About Amniocentesis Before the Procedure on Maternal Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
December 30, 2022 (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 effect of exposure to an informative video about amniocentesis before the procedure on maternal anxiety
Detailed Description
Amniocentesis is a common sonography-guided procedure that is usually preformed during the second trimester of pregnancy in order to obtain neonatal genetic information. Previous studies have shown that although the risk of a major complication is small, many women experience profound anxiety regarding the procedure.
Many stress-relieving techniques have been proposed and studied concerning stress-related interventions during pregnancy. However, the use of an informative video that is a simple, accessible, widely accepted tool has not been tested in the context of amniocentesis. In this interventional study the investigators aim to examine the effect of an informative pre-procedural video on anxiety and pain levels in women undergoing amniocentesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Anxiety in Pregnancy, Amniocentesis Affecting Fetus or Newborn
Keywords
explanatory video, anxiety reduction, amniocentesis, pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Women assigned to undergo amniocentesis during the trail time-period will be invited to participate in the study and will be signed a consent form.The randomization will be based on different days for each intervention - a day specified to women comprising of the research group while the following clinic day will be dedicated to women from the control group.
The study group will watch an informative video while waiting for amniocentesis, and the control group will not watch the video while waiting.
Masking
Outcomes Assessor
Masking Description
Data regarding maternal characteristics, anxiety and pain levels as reported by the patients via the questioners will be stored according to random serial numbers without intervention type. The investigator handling the statistical analysis will be unaware of the patient's exposure.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Informative video
Arm Type
Experimental
Arm Description
The research group will be exposed to an informative instructional film before the procedure.
Arm Title
No video
Arm Type
No Intervention
Arm Description
The control group will undergo amniocentesis with information given as accepted by standard-of-care.
Intervention Type
Other
Intervention Name(s)
Informative video
Intervention Description
An informative instructional film regarding the amniocentesis procedure including answers to frequently asked questions.
Primary Outcome Measure Information:
Title
Assessment of change in anxiety levels between before and after undergoing the amniocentesis
Description
Women recruited to the study will answer the Spielberger's state-trait anxiety inventory questionnaire- a validated questionnaire for assessing anxiety which includes 20 statements expressing different states of anxiety. The patients will be asked to rate to what extent they currently relate to the statement written on a scale of 1 to 4 (1- does not agree at all and 4- strongly agrees). The final score in each questionnaire is obtained by summing the scores of each statement, while the scores of positive statements reflecting anxiety-free behavior will be reversely summed. Higher scores indicate higher level of anxiety.
Time Frame
Each patient will answer the STAI questionnaire twice - within 2 hours before the operation and watching the video (S1) and within 30 minutes after performing amniocentesis (S2) to assess the change in anxiety levels before and after the operation
Secondary Outcome Measure Information:
Title
Intensity of pain, discomfort, satisfaction with the video and satisfaction in general
Description
These parameters will be measured using the item visual analog scales 11 questionnaire containing questions reflecting pain, discomfort and satisfaction levels. Each statement scores between 0-10 as a reflection of the patients' identification with the statement- each statement reflecting different aspects of the patients' experience:
question 1- pain during the procedure question 2- pain 10 minutes after the procedure question 3- general unpleasantness question 4- anxiety during procedure question 5- satisfaction with information about procedure question 6- overall satisfaction with treatment question 7- level of discomfort as a result of informative video prior to the amniocentesis question 8- level of anxiety caused by watching the informative video question 9-importance of informative video for understanding the amniocentesis procedure
Time Frame
The questionnaire will be filled within 30 minutes after performing amniocentesis
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women who come for amniocentesis in the Edith Wolfson Medical Center
Women who sign a consent form to enroll to the study.
Exclusion Criteria:
Women under 18 years of age.
Women who do not speak Hebrew
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Or Marom, Dr
Organizational Affiliation
Edith Wolfson Medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edith Wolfson Medical Center
City
H̱olon
ZIP/Postal Code
5822012
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Unidentified patient data will be shared between researchers for statistical analysis, other unidentified data will be published.
IPD Sharing Time Frame
Within the first 5 years from publication.
IPD Sharing Access Criteria
Researches in need of data will request permission from study organizers by mail including data needed, purpose of data sharing and data protection steps.
Learn more about this trial
The Effect of Exposure to an Informative Video About Amniocentesis Before the Procedure on Maternal Anxiety
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