AnxietyNCT04136301
The Effect of Exposure to an Informative Video on Maternal Anxiety
A study testing Informative Video group in people with Anxiety and Labor Pain, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
Stress and anxiety during childbirth have negative consequence on both mother and fetus. Previous studies have learned the effect of several intervention to reduce anxiety during labor- such as music and foot reflexology. Nevertheless, data for informative video before labor for reducing stress and anxiety are sparse. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Labor Pain, Patient Satisfaction
- What is being tested?
- Informative Video group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2019to 30 Aug 2020
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- above 18 years of age Nulliparus women Informed consent Reads and understand Hebrew >37 weeks of gestation
Who cannot join
- Refuse to participate Contraindications for vaginal delivery
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson medical center
Holon
Hadas Miremberg, MD, 972526741740, dasile2@gmail.com
About this study
Official title: The Effect of Exposure to an Informative Video Regarding Possible Obstetric Emergencies on Maternal Anxiety and Peripartum Satisfaction- A Randomized Controlled Trial
Stress and anxiety during childbirth have negative consequence on both mother and fetus. Previous studies have learned the effect of several intervention to reduce anxiety during labor- such as music and foot reflexology. Nevertheless, data for informative video before labor for reducing stress and anxiety are sparse. The present study aimed to review and determine the effect of informative video on anxiety, pain and outcomes of the labor in primigravida women.
Read the detailed description
A randomized control trial studying the effect of exposure to an informative video regarding labor and possible obstetrics emergencies on maternal anxiety and postpartum satisfaction
- Conditions
- Anxiety, Labor Pain, Patient Satisfaction
- Being tested
- Informative Video group
- Medical subject headings
- Anxiety Disorders, Labor Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informative Video groupOther
Informative Video group before labor in nulliparous women
| Study group | Role | What they receive |
|---|---|---|
| Informative video arm | Experimental | Nuliparus women admitted to an induction will be exposed to informative video with data regarding labor and possible obstetric emergencies such as cesarean delivery.
All patients will answer the State-Trait Anxiety Inventory (STAI) before and after intervention Receives: Other: Informative Video group |
| control arm | No intervention | no intervention. All patients will answer the State-Trait Anxiety Inventory (STAI) before and after delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The State-Trait Anxiety Inventory score in delivery room
STAI questionnaire before and after delivery room
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136301
- Sponsor's protocol ID
- 0093-19-WOMC
- Status last verified
- Oct 2019
- First submitted
- 1 Sep 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- 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 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exposure to an Informative Video Regarding Possible Obstetric Emergencies on Maternal Anxiety and Peripartum Satisfaction- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04136301
- Acronym / sponsor ID
- 0093-19-WOMC
- Conditions
- Anxiety, Labor Pain, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 23 Oct 2019 (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.
Stress and anxiety during childbirth have negative consequence on both mother and fetus. Previous studies have learned the effect of several intervention to reduce anxiety during labor- such as music and foot reflexology. Nevertheless, data for informative video before labor for reducing stress and anxiety are sparse. The present study aimed to review and determine the effect of informative video on anxiety, pain and outcomes of the labor in primigravida women.
Detailed description
A randomized control trial studying the effect of exposure to an informative video regarding labor and possible obstetrics emergencies on maternal anxiety and postpartum satisfaction
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Informative video arm | Experimental | Other: Informative Video groupNuliparus women admitted to an induction will be exposed to informative video with data regarding labor and possible obstetric emergencies such as cesarean delivery. All patients will answer the State-Trait Anxiety Inventory (STAI) before and after intervention |
| control arm | No intervention | –no intervention. All patients will answer the State-Trait Anxiety Inventory (STAI) before and after delivery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- above 18 years of age Nulliparus women Informed consent Reads and understand Hebrew >37 weeks of gestation
Key exclusion criteria (1 listed)
- Refuse to participate Contraindications for vaginal delivery
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 Video groupInformative Video group before labor in nulliparous women | Other | Informative video arm |
Primary outcome
The State-Trait Anxiety Inventory score in delivery room
Time frame: 1 hour
STAI questionnaire before and after delivery room
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Individual participant dataSharing planned: No
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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.
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 group in people with Anxiety and Labor Pain, 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 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: status not confirmed, as of the sponsor's last update on 23 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The State-Trait Anxiety Inventory score in delivery room (time frame: 1 hour). 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 23 Oct 2019.