Pregnancy Related Clinical Trial
Official title:
The Effect of Exposure to an Informative Video About Amniocentesis Before the Procedure on Maternal Anxiety
Verified date | March 2023 |
Source | Wolfson Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The effect of exposure to an informative video about amniocentesis before the procedure on maternal anxiety
Status | Completed |
Enrollment | 100 |
Est. completion date | December 30, 2022 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Israel | Edith Wolfson Medical Center | H_olon |
Lead Sponsor | Collaborator |
---|---|
Wolfson Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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 | 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 |
The questionnaire will be filled within 30 minutes after performing amniocentesis |
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