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

NCT05463549 | Completed

• 1 other identifier: 0169-21-WOMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy Related; Anxiety in Pregnancy; Amniocentesis Affecting Fetus or Newborn

Keywords

explanatory video; anxiety reduction; amniocentesis; pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  The questionnaire will be filled within 30 minutes after performing amniocentesis

Study Arms (2)

Informative video

EXPERIMENTAL

The research group will be exposed to an informative instructional film before the procedure.

Other: Informative video

No video

NO INTERVENTION

The control group will undergo amniocentesis with information given as accepted by standard-of-care.

Interventions

Informative video OTHER

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

Informative video

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who come for amniocentesis in the Edith Wolfson Medical Center
• Women who sign a consent form to enroll to the study.

You may not qualify if:

• Women under 18 years of age.
• Women who do not speak Hebrew

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Edith Wolfson Medical Center

Holon, 5822012, Israel

Location

Related Publications (1)

• Marom O, Weiner E, Gindes L, Mor L, Gury M, Toledano E, Alon AS, Miremberg H, Shalev J, Levy M. The effect of watching an informational video prior amniocentesis on maternal anxiety: a randomized controlled trail. Arch Gynecol Obstet. 2024 Aug;310(2):1001-1008. doi: 10.1007/s00404-023-07288-y. Epub 2023 Dec 7.

  PMID: 38060016 DERIVED

Study Officials

• Or Marom, Dr

  Edith Wolfson Medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: July 19, 2022
• Study Start: February 8, 2022
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within the first 5 years from publication.
• 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.

Locations

IL (1)