Pregnancy RelatedNCT05463549
The Effect of Exposure to an Informative Video About Amniocentesis Before the Procedure on Maternal Anxiety
A study testing Informative video in people with Pregnancy Related and Anxiety in Pregnancy, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
The effect of exposure to an informative video about amniocentesis before the procedure on maternal anxiety Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Anxiety in Pregnancy, Amniocentesis Affecting Fetus or Newborn
- What is being tested?
- Informative video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 8 Feb 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who come for amniocentesis in the Edith Wolfson Medical Center
- Women who sign a consent form to enroll to the study.
Who cannot join
- Women under 18 years of age.
- Women who do not speak Hebrew
Trial locations and contacts
1 site in 1 country.
About this study
The effect of exposure to an informative video about amniocentesis before the procedure on maternal anxiety
Read the 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.
- Being tested
- Informative video
- Keywords
- explanatory video, anxiety reduction, amniocentesis, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informative videoOther
An informative instructional film regarding the amniocentesis procedure including answers to frequently asked questions.
| Study group | Role | What they receive |
|---|---|---|
| Informative video | Experimental | The research group will be exposed to an informative instructional film before the procedure. Receives: Other: Informative video |
| No video | No intervention | The control group will undergo amniocentesis with information given as accepted by standard-of-care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: The questionnaire will be filled within 30 minutes after performing amniocentesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start8 Feb 2022
- Primary completion30 Oct 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Or Marom, Dr, Principal investigator, Edith Wolfson Medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463549
- Sponsor's protocol ID
- 0169-21-WOMC
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unidentified patient data will be shared between researchers for statistical analysis, other unidentified data will be published.
Publications
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.
PubMed 38060016
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exposure to an Informative Video About Amniocentesis Before the Procedure on Maternal Anxiety
- ClinicalTrials.gov ID
- NCT05463549
- Acronym / sponsor ID
- 0169-21-WOMC
- Keywords
- explanatory video, anxiety reduction, amniocentesis, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Informative video | Experimental | Other: Informative videoThe research group will be exposed to an informative instructional film before the procedure. |
| No video | No intervention | –The control group will undergo amniocentesis with information given as accepted by standard-of-care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women who come for amniocentesis in the Edith Wolfson Medical Center
- Women who sign a consent form to enroll to the study.
Key exclusion criteria (2 listed)
- Women under 18 years of age.
- Women who do not speak Hebrew
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informative videoAn informative instructional film regarding the amniocentesis procedure including answers to frequently asked questions. | Other | Informative video |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 38060016Marom 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.
- Individual participant dataSharing planned: Yes. Unidentified patient data will be shared between researchers for statistical analysis, other unidentified data will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Or Marom, Dr principal investigator
Edith Wolfson Medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informative video in people with Pregnancy Related and Anxiety in Pregnancy, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05463549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.