AmniocentesisNCT06555653
The Effect of Video-based Multimedia Information Before Amniocentesis on Pain, Anxiety and Pregnancy Outcomes
An observational study of Amniocentesis and Video Information, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to assess the effect of video-based multimedia information before amniocentesis on pain, anxiety and pregnancy outcomes Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amniocentesis, Video Information
- What is being tested?
- Video based multimedia information
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 20 Jun 2024
- Phase
- Observational
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who received video based multimedia information about amniocentesis
Who may be able to join
- All consecutive women aged 18-45 years scheduled for amniocentesis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam and Sakura City Hospital
Istanbul
About this study
The goal of this clinical trial is to assess the effect of video-based multimedia information before amniocentesis on pain, anxiety and pregnancy outcomes
Read the detailed description
Amniocentesis is the most commonly used invasive prenatal diagnostic test. This study aimed to investigate the effect of video-based multimedia information (MMI) on the anxiety and pain levels of patients undergoing amniocentesis.
All consecutive women aged 18-45 years scheduled for amniocentesis were included in this prospective randomized controlled study. Subjects were assigned to receive video-based MMI or traditional written information (controls). Anxiety levels were assessed at the first admission using the State and Trait Anxiety Inventory-State (STAI-S). After MMI and written information, STAI-S was repeated before the procedure. A standard amniocentesis procedure was performed on all patients by the same perinatology physicians. After amniocentesis, a Likert scale was used to evaluate the ease of the procedure and patient satisfaction, and a visual analog scale was used to evaluate pain. Pregnancy results and amniocentesis results were noted
- Conditions
- Amniocentesis, Video Information
- Being tested
- Video based multimedia information
- Keywords
- Video-based information, amniocentesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video based multimedia informationOther
The intervention group was shown a 5 minute informational video before amniocentesis including definition of amniocentesis, its indications, the setup of amniocentesis room, the purpose and steps of the procedure, potential complications and how to manage them
| Study group | Role | What they receive |
|---|---|---|
| Subjects received video-based multmedia information | Not described Receives: Other: Video based multimedia information | |
| Subjects received traditional written information | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of video based information on pain levels
Subjects were assigned to receive video-based MMI or traditional written information (controls). A standard amniocentesis procedure was performed on all patients by the same perinatology physicians. After amniocentesis a visual analog scale was used to evaluate pain.
Measured: 01.12.2023- 01.04.2024
To assess the effect of video based information on anxiety
Subjects were assigned to receive video-based MMI or traditional written information (controls). Anxiety levels were assessed at the first admission using the State and Trait Anxiety Inventory-State (STAI-S). After MMI and written information, STAI-S was repeated before the procedure.
Measured: 01.12.2023- 01.04.2024
To assess the effect of video based information on ease of procedure
Subjects were assigned to receive video-based MMI or traditional written information (controls). A standard amniocentesis procedure was performed on all patients by the same perinatology physicians. After amniocentesis, a Likert scale was used to evaluate the ease of the procedure and patient satisfaction,
Measured: 01.12.2023- 01.04.2024
To assess the effect of video based information on pregnancy outcome
Subjects were assigned to receive video-based MMI or traditional written information (controls).The birth outcomes were compared between the two groups in terms of live birth, termination of pregnancy, and intrauterine death.
Measured: 01.12.2023- 01.04.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Dec 2023
- Primary completion1 Apr 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmniocentesisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nihal Callıoglu, Study director, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555653
- Sponsor's protocol ID
- 2023-571
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Video-based Multimedia Information Before Amniocentesis on Pain, Anxiety and Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT06555653
- Acronym / sponsor ID
- 2023-571
- Conditions
- Amniocentesis, Video Information
- Keywords
- Video-based information, amniocentesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 15 Aug 2024 (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 goal of this clinical trial is to assess the effect of video-based multimedia information before amniocentesis on pain, anxiety and pregnancy outcomes
Detailed description
Amniocentesis is the most commonly used invasive prenatal diagnostic test. This study aimed to investigate the effect of video-based multimedia information (MMI) on the anxiety and pain levels of patients undergoing amniocentesis.
All consecutive women aged 18-45 years scheduled for amniocentesis were included in this prospective randomized controlled study. Subjects were assigned to receive video-based MMI or traditional written information (controls). Anxiety levels were assessed at the first admission using the State and Trait Anxiety Inventory-State (STAI-S). After MMI and written information, STAI-S was repeated before the procedure. A standard amniocentesis procedure was performed on all patients by the same perinatology physicians. After amniocentesis, a Likert scale was used to evaluate the ease of the procedure and patient satisfaction, and a visual analog scale was used to evaluate pain. Pregnancy results and amniocentesis results were noted
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects received video-based multmedia information | – | Other: Video based multimedia information |
| Subjects received traditional written information | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who received video based multimedia information about amniocentesis
Key inclusion criteria (1 listed)
- All consecutive women aged 18-45 years scheduled for amniocentesis
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Video based multimedia informationThe intervention group was shown a 5 minute informational video before amniocentesis including definition of amniocentesis, its indications, the setup of amniocentesis room, the purpose and steps of the procedure, potential complications and how to manage them | Other | Subjects received video-based multmedia information |
Primary outcome
To assess the effect of video based information on pain levels
Time frame: 01.12.2023- 01.04.2024
Subjects were assigned to receive video-based MMI or traditional written information (controls). A standard amniocentesis procedure was performed on all patients by the same perinatology physicians. After amniocentesis a visual analog scale was used to evaluate pain.
To assess the effect of video based information on anxiety
Time frame: 01.12.2023- 01.04.2024
Subjects were assigned to receive video-based MMI or traditional written information (controls). Anxiety levels were assessed at the first admission using the State and Trait Anxiety Inventory-State (STAI-S). After MMI and written information, STAI-S was repeated before the procedure.
To assess the effect of video based information on ease of procedure
Time frame: 01.12.2023- 01.04.2024
Subjects were assigned to receive video-based MMI or traditional written information (controls). A standard amniocentesis procedure was performed on all patients by the same perinatology physicians. After amniocentesis, a Likert scale was used to evaluate the ease of the procedure and patient satisfaction,
To assess the effect of video based information on pregnancy outcome
Time frame: 01.12.2023- 01.04.2024
Subjects were assigned to receive video-based MMI or traditional written information (controls).The birth outcomes were compared between the two groups in terms of live birth, termination of pregnancy, and intrauterine death.
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 15 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Amniocentesis
Recruiting
Effect of Video -Based vs Standard ınformation on Maternal Anxiety and Procedure Decision in Pregnant Woman Offered Amniocentesis or Cvs
Maternal Anxiety, Prenatal Diagnosis
RecruitingObservational study
Outcomes of Children in Whom a Prenatal Exome Was Performed Based on Ultrasound Findings
Amniocentesis Affecting Fetus
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.
Nihal Callıoglu study director
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amniocentesis and Video Information, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 15 Aug 2024. 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 Turkey (Türkiye). 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?
To assess the effect of video based information on pain levels (time frame: 01.12.2023- 01.04.2024). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.