Maternal Distress (During Labor)NCT04176107

The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety

A study testing Informative video in people with Maternal Distress (During Labor) and Anxiety, run by Wolfson Medical Center at 4 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Maternal Distress (During Labor), Anxiety
What is being tested?: Informative video
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 4 sitesIsrael
Study dates: 26 Aug 2019to 1 Dec 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

Hebrew speaking
Informed consent
First cesarean delivery
Non emergent elective CD

Who cannot join

Non Hebrew speaking
Refuse to participate
Emergency CD

Trial locations and contacts

4 sites in 1 country.

Israel4 sites

Haemek Medical Center
Afula
Asuta Medical Center
Ashdod
Rambam Medical Center
Haifa
Wolfson medical center
Holon

Other trials in Israel

About this study

Official title: The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety and Peripartum Satisfaction- a Randomized Control Trial

The incidence of cesarean deliveries (CD) worldwide is increasing, around 30% in United States. Although very common surgery women undergoing non emergent CD still experience fear and anxiety. It is known that increased levels of stress can negatively affect pain perception and the usage of analgesics postoperatively as well as lactation.

this present study investigate the effect of exposure to informative video before cesarean delivery on maternal anxiety.

Read the detailed description

A multi-center randomized control trial the will examine the effect of exposure to informative video before cesarean delivery on maternal anxiety and satisfaction

Conditions: Maternal Distress (During Labor), Anxiety
Being tested: Informative video
Keywords: Cesarean delivery, Anxiety, Informative-video
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Informative videoBehavioural
Exposure to informative video before cesarean delivery

Study groups in NCT04176107
Study group	Role	What they receive
Study group- video+questionnaire	Other	The study group will be exposed to a video at admission to an elective cesarean delivery. The video will have information regarding the admission, pre-operation preparation and post- operation recovery. All patients will answer a questionnaire at admission, before surgery and 24 hours later. the questionnaires will evaluate the impact of exposure to informative video before caesarean delivery on anxiety and stress measured by State-Trait Anxiety Inventory (STAI). Receives: Behavioral: Informative video
Control group- questionnaire only	No intervention	All patients will answer a questionnaire at admission, before surgery and 24 hours later. the questionnaires will evaluate anxiety and stress measured by State-Trait Anxiety Inventory (STAI) without intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

The State-Trait Anxiety Inventory STAI:Y-1
Psychological questionnaire to assess stress and anxiety-The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 20 questions on a self-report basis. Higher scores are positively correlated with higher levels of anxiety.
Measured: Baseline (Questionnaire filled by the patient Before operation)

Secondary outcomes (2)

The State-Trait Anxiety Inventory STAI:Y-1
Psychological questionnaire to assess stress and anxietyhe State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 20 questions on a self-report basis. Higher scores are positively correlated with higher levels of anxiety.
Measured: Questionnaire filled by the patient at admission- 1 day before operation
Childbirth experience questionnaire (CEQ)
Questionnaire to evaluate the women experience and satisfaction
Measured: Questionnaire filled by the patient at 1 day after the delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Aug 20191 Dec 2020

First posted25 Nov 2019
Study start26 Aug 2019
Primary completion1 Dec 2020
Study completion1 Dec 2020

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 Maternal Distress (During Labor)Studies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04176107
Sponsor's protocol ID: 0092-19-WOMC
Status last verified: Nov 2019
First submitted: 22 Oct 2019
Last updated: 2 Mar 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Miremberg H, Yirmiya K, Vinter D, Lauterbach R, Yefet E, Nassra R, Paz YG, Hagege R, Weiner E. An informative video before planned cesarean delivery and maternal anxiety-a multicenter randomized controlled trial. Am J Obstet Gynecol MFM. 2022 May;4(3):100604. doi: 10.1016/j.ajogmf.2022.100604. Epub 2022 Feb 28.
PubMed 35240345

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety and Peripartum Satisfaction- a Randomized Control Trial
ClinicalTrials.gov ID: NCT04176107
Acronym / sponsor ID: 0092-19-WOMC
Conditions: Maternal Distress (During Labor), Anxiety
Keywords: Cesarean delivery, Anxiety, Informative-video
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Wolfson Medical CenterOther government
Study start: 26 Aug 2019 (actual)
Primary completion: 1 Dec 2020 (actual)
Study completion: 1 Dec 2020 (actual)
First posted: 25 Nov 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.

this present study investigate the effect of exposure to informative video before cesarean delivery on maternal anxiety.

Detailed description

A multi-center randomized control trial the will examine the effect of exposure to informative video before cesarean delivery on maternal anxiety and satisfaction

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Study group- video+questionnaire	Other	Behavioral: Informative videoThe study group will be exposed to a video at admission to an elective cesarean delivery. The video will have information regarding the admission, pre-operation preparation and post- operation recovery. All patients will answer a questionnaire at admission, before surgery and 24 hours later. the questionnaires will evaluate the impact of exposure to informative video before caesarean delivery on anxiety and stress measured by State-Trait Anxiety Inventory (STAI).
Control group- questionnaire only	No intervention	–All patients will answer a questionnaire at admission, before surgery and 24 hours later. the questionnaires will evaluate anxiety and stress measured by State-Trait Anxiety Inventory (STAI) without intervention.

Who may qualify

Ages: 18 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Hebrew speaking
Informed consent
First cesarean delivery
Non emergent elective CD

Key exclusion criteria (3 listed)

Non Hebrew speaking
Refuse to participate
Emergency CD

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 videoExposure to informative video before cesarean delivery	Behavioural	Study group- video+questionnaire

Primary outcome

The State-Trait Anxiety Inventory STAI:Y-1
Time frame: Baseline (Questionnaire filled by the patient Before operation)
Psychological questionnaire to assess stress and anxiety-The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 20 questions on a self-report basis. Higher scores are positively correlated with higher levels of anxiety.

2 secondary outcomes

The State-Trait Anxiety Inventory STAI:Y-1
Time frame: Questionnaire filled by the patient at admission- 1 day before operation
Childbirth experience questionnaire (CEQ)
Time frame: Questionnaire filled by the patient at 1 day after the delivery

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 2 Mar 2021.
Derived from this study: PubMed 35240345Miremberg H, Yirmiya K, Vinter D, Lauterbach R, Yefet E, Nassra R, Paz YG, Hagege R, Weiner E. An informative video before planned cesarean delivery and maternal anxiety-a multicenter randomized controlled trial. Am J Obstet Gynecol MFM. 2022 May;4(3):100604. doi: 10.1016/j.ajogmf.2022.100604. Epub 2022 Feb 28.
Individual participant dataSharing planned: No

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.

hadas miremberg, MD principal investigator

Wolfson Medical Center

4 sites 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 Maternal Distress (During Labor) and Anxiety, run by Wolfson Medical Center at 4 sites 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 4 inclusion and 3 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 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The State-Trait Anxiety Inventory STAI:Y-1 (time frame: Baseline (Questionnaire filled by the patient Before 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 NCT04176107, 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 2 Mar 2021.