AnxietyNCT00699127
Organizing the Information Given to Parents of NICU Infants in Order to Reduce Their Anxiety
A study testing Lecture in people with Anxiety, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. Read more about this study
- Who is it for?
- Ages Up to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Lecture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to Jul 2008
- 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 Up to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents to premature infants, after releasing the mother
Who cannot join
- Term infants
- Hospitalized mother
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Organizing the Information Given to Parents of NICU Infants Reduce Their Anxiety?
Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.
Read the detailed description
Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.
- Conditions
- Anxiety
- Being tested
- Lecture
- Keywords
- anxiety, parents, NICU, prematurity, Anxiety of parents to NICU infants
- Medical subject headings
- Anxiety Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LectureBehavioural
Lecture of information regarding prematurity, NICU hospitalization, etc.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The group that will have lecture of information regarding infants in NICU. Receives: Behavioral: Lecture |
| 2 | No intervention | The group that will not have lecture of information regarding NICU hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between questionnaires at the first week and the last week to hospitalization.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2008 (estimated)
- Study completionJul 2008 (estimated)
Why it stopped: After a discussion, we decided to withdraw the study.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Investigators
- Erez Nadir, MD, Study chair, Hillel Yaffe medical center, Hadera, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699127
- Sponsor's protocol ID
- HY-19-2008-CTIL
- Status last verified
- Jul 2008
- First submitted
- 14 Jun 2008
- Last updated
- 4 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Organizing the Information Given to Parents of NICU Infants Reduce Their Anxiety?
- ClinicalTrials.gov ID
- NCT00699127
- Acronym / sponsor ID
- HY-19-2008-CTIL
- Conditions
- Anxiety
- Keywords
- anxiety, parents, NICU, prematurity, Anxiety of parents to NICU infants
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: After a discussion, we decided to withdraw the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jul 2008
- Primary completion
- Jul 2008 (estimated)
- Study completion
- Jul 2008 (estimated)
- First posted
- 17 Jun 2008 (estimated)
- 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.
Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.
Detailed description
Being a parent to a premature infant in NICU is an anxious state. Parents ask a lot of questions, and look for information all the time. Organizing the information given to parents could reduce their anxiety. The parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. Of course, questions will be answered all the time. The parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: LectureThe group that will have lecture of information regarding infants in NICU. |
| 2 | No intervention | –The group that will not have lecture of information regarding NICU hospitalization |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parents to premature infants, after releasing the mother
Key exclusion criteria (2 listed)
- Term infants
- Hospitalized mother
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 |
|---|---|---|
| LectureLecture of information regarding prematurity, NICU hospitalization, etc. | Behavioural | 1 |
Primary outcome
Difference between questionnaires at the first week and the last week to hospitalization.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2008.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Erez Nadir, MD study chair
Hillel Yaffe medical center, Hadera, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lecture in people with Anxiety, run by Hillel Yaffe 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 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: withdrawn, as of the sponsor's last update on 4 Jul 2008. 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 was withdrawn before enrolling participants, so there are no results.
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?
Difference between questionnaires at the first week and the last week to hospitalization. (time frame: 1 year). 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 4 Jul 2008.