Clinical trial NCT05463549: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Anxiety in Pregnancy
Amniocentesis Affecting Fetus or Newborn
Keywords: explanatory video
anxiety reduction
amniocentesis
pregnancy
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-07-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Assessment of change in anxiety levels between before and after undergoing the amniocentesis
timeFrame: 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 outcomes:
measure: Intensity of pain, discomfort, satisfaction with the video and satisfaction in general
timeFrame: The questionnaire will be filled within 30 minutes after performing amniocentesis
Other outcomes:
Locations:
city: H̱olon
country: Israel
facility: Edith Wolfson Medical Center
Study officials:
affiliation: Edith Wolfson Medical center
name: Or Marom, Dr
role: PRINCIPAL_INVESTIGATOR
References: