PregnancyNCT03330860
Effectiveness of 12 Clips in Maternal and Neoanatal Health Through Applied Neuroscience Tools (Neuromarketing Strategy)
A study testing Twelve clips regarding maternal and neonatal health topics in people with Pregnancy, run by Universidad Nacional de Colombia at 1 site in Colombia.
Trial summary
Objective: To evaluate the effectiveness of 12 knowledge transfer clips of maternal and neonatal health in order to generate knowledge appropriation. Methodology: Randomized cross-over clinical trial with a non-probabilistic sample of intentional feature of 150 subjects: pregnant women, non-pregnant women and men. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Twelve clips regarding maternal and neonatal health topics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteColombia
- Study dates
- 16 Nov 2015to 15 Jan 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women, Men, and Non-pregnant women that accept to participate in the study
Who cannot join
- Participant that don't sign informed consent or have clinically significant visual or auditory impairment
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To evaluate the effectiveness of 12 knowledge transfer clips of maternal and neonatal health in order to generate knowledge appropriation. Methodology: Randomized cross-over clinical trial with a non-probabilistic sample of intentional feature of 150 subjects: pregnant women, non-pregnant women and men. Participants will be evaluated during the observation of 13 clips (one of them is the control clip) in which sequence will be assigned randomly. The level of attention will be assessed by means of eye tracking, to see the ocular gaze and fixation in relation to the content of clips, and emotional reaction through the psychophysiological record (galvanic skin response). In addition, recall of information will be assessed through the application of questionnaires at the end of each video. The analysis will focus on identifying differences in the three outcomes between intervention clips and the control clip, and between the three groups, and determine the clips and segments that generate greater emotional response, attention and recall.
- Conditions
- Pregnancy
- Being tested
- Twelve clips regarding maternal and neonatal health topics, Control Clip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twelve clips regarding maternal and neonatal health topicsOther
Twelve clips regarding maternal and neonatal health topics, designed with mixed 2D and 3D elements, each one about 45 seconds long (prepared based on the best available evidence and validated by clinical experts).
Control ClipOther
Control clip with 2D elements about 45 seconds long, containing information on prenatal control and presented in conventional format (narration, static images and on screen text).
| Study group | Role | What they receive |
|---|---|---|
| Neuromarketing strategy | Experimental | Twelve clips regarding maternal and neonatal health topics, designed with mixed 2D and 3D elements, each one about 45 seconds long (prepared based on the best available evidence and validated by clinical experts). Receives: Other: Twelve clips regarding maternal and neonatal health topics |
| No-capsule group | Active comparator | Control clip with 2D elements about 45 seconds long, containing information on prenatal control and presented in conventional format (narration, static images and on screen text). Receives: Other: Control Clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional impact (electrodermal activity)
Monitoring of autonomous activity will be carried out through the registration of electrodermal activity (galvanic skin response), which allows the evaluation of emotional reaction. Electrodermal activity will be measured by a computerized psychophysiological recording equipment. The electrodes will be placed in the distal phalanx of the third and fourth finger of the non-dominant hand with SE-35 sensors connected to a T-601 preamplifier (J \& J Enterprises Seattle, WA).
The analysis of skin conductance will be carried out with the amplitude of electrodermal response which is obtained by the subtraction of the lowest conductance of the latency period from the peak conductance. This analysis will be performed for each event identified in each clip for each subject.
Measured: 1 day
Secondary outcomes (2)
Recall (Questionnarie)
The measurement of the recall component will be carried out by filling out a knowledge test in form of questionnaire once the screening of each video has finished. The proportion of correct answers by questionnaire will be calculated.
Measured: 1 day
Attention (Eye tracking)
The eye tracking method will be applied to evaluate the attention to the visual stimulus of the clips. By means of the Eye Tracker Tobii Tx300 tracking equipment, the eye movements will be recorded. The record of how and when gaze is focused on the areas of interest (AOIs) will be measured with the following variables: 1. Duration until the first fixation in an AOI (Time to First Fixation - TFF) in seconds, and number of fixations before focusing on an AOI (Fixations Before - FB). These two measures indicate the anticipation with which attention is fixed in a specific area of the screen. 2. Duration and number of all fixations made in an AOI. These measurements indicate the duration of the fixation in each AOI and the number of times the participant fixes his gaze on that area.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start16 Nov 2015
- Primary completion1 Dec 2017
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330860
- Sponsor's protocol ID
- Capsule1
- Status last verified
- Nov 2018
- First submitted
- 19 Nov 2015
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of 12 Clips in Maternal and Neoanatal Health Through Applied Neuroscience Tools (Neuromarketing Strategy)
- ClinicalTrials.gov ID
- NCT03330860
- Acronym / sponsor ID
- Capsule1
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 6 Nov 2017 (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.
Objective: To evaluate the effectiveness of 12 knowledge transfer clips of maternal and neonatal health in order to generate knowledge appropriation. Methodology: Randomized cross-over clinical trial with a non-probabilistic sample of intentional feature of 150 subjects: pregnant women, non-pregnant women and men. Participants will be evaluated during the observation of 13 clips (one of them is the control clip) in which sequence will be assigned randomly. The level of attention will be assessed by means of eye tracking, to see the ocular gaze and fixation in relation to the content of clips, and emotional reaction through the psychophysiological record (galvanic skin response). In addition, recall of information will be assessed through the application of questionnaires at the end of each video. The analysis will focus on identifying differences in the three outcomes between intervention clips and the control clip, and between the three groups, and determine the clips and segments that generate greater emotional response, attention and recall.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Neuromarketing strategy | Experimental | Other: Twelve clips regarding maternal and neonatal health topicsTwelve clips regarding maternal and neonatal health topics, designed with mixed 2D and 3D elements, each one about 45 seconds long (prepared based on the best available evidence and validated by clinical experts). |
| No-capsule group | Active comparator | Other: Control ClipControl clip with 2D elements about 45 seconds long, containing information on prenatal control and presented in conventional format (narration, static images and on screen text). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women, Men, and Non-pregnant women that accept to participate in the study
Key exclusion criteria (1 listed)
- Participant that don't sign informed consent or have clinically significant visual or auditory impairment
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 |
|---|---|---|
| Twelve clips regarding maternal and neonatal health topicsTwelve clips regarding maternal and neonatal health topics, designed with mixed 2D and 3D elements, each one about 45 seconds long (prepared based on the best available evidence and validated by clinical experts). | Other | Neuromarketing strategy |
| Control ClipControl clip with 2D elements about 45 seconds long, containing information on prenatal control and presented in conventional format (narration, static images and on screen text). | Other | No-capsule group |
Primary outcome
Emotional impact (electrodermal activity)
Time frame: 1 day
Monitoring of autonomous activity will be carried out through the registration of electrodermal activity (galvanic skin response), which allows the evaluation of emotional reaction. Electrodermal activity will be measured by a computerized psychophysiological recording equipment. The electrodes will be placed in the distal phalanx of the third and fourth finger of the non-dominant hand with SE-35 sensors connected to a T-601 preamplifier (J \& J Enterprises Seattle, WA). The analysis of skin conductance will be carried out with the amplitude of electrodermal response which is obtained by the subtraction of the lowest conductance of the latency period from the peak conductance. This analysis will be performed for each event identified in each clip for each subject.
2 secondary outcomes
Recall (Questionnarie)
Time frame: 1 day
Attention (Eye tracking)
Time frame: 1 day
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 27 Nov 2018.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twelve clips regarding maternal and neonatal health topics in people with Pregnancy, run by Universidad Nacional de Colombia at 1 site in Colombia.
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 27 Nov 2018. 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 Colombia. 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?
Emotional impact (electrodermal activity) (time frame: 1 day). 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 27 Nov 2018.