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Completed

NCT Number: NCT05463549

The Effect of Exposure to an Informative Video About Amniocentesis Before the Procedure on Maternal Anxiety

The effect of exposure to an informative video about amniocentesis before the procedure on maternal anxiety

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Key information

Conditions

Pregnancy Related Amniocentesis Affecting Fetus or Newborn Anxiety in Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Edith Wolfson Medical Center

Holon, 5822012, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informative video

Other

An informative instructional film regarding the amniocentesis procedure including answers to frequently asked questions.

Primary outcomes

  1. Assessment of change in anxiety levels between before and after undergoing the amniocentesis

    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

    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 outcomes

  1. Intensity of pain, discomfort, satisfaction with the video and satisfaction in general

    Time frame: The questionnaire will be filled within 30 minutes after performing amniocentesis

    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

Sponsors and collaborators

Lead sponsor

Wolfson Medical Center

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2022
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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