Perinatal DeathNCT06169423
Simulation of Perinatal Grief. (SPG)
A study testing Educative intervention in people with Perinatal Death and Perinatal Grief, run by Universitat Jaume I at 1 site in Spain.
Trial summary
A proposal for teaching innovation is proposed with the topic of "perinatal grief" very little studied and taught in degrees such as medicine, nursing and psychology, with scientific evidence demonstrating a knowledge deficit on the part of healthcare professionals. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Perinatal Death, Perinatal Grief, Teaching Innovation
- What is being tested?
- Educative intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 30 Jun 2023
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: The sample population will be nursing students. Specifically, the project will be proposed and offered to students who have taken the subject "Women's Care" in the third year.
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Exclusion Criteria: Those students who did not come to class the day that the activity took place, were excluded.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simulation of Perinatal Grief. Assessment of Knowledge Acquisition, Support Skills, Self-awareness and Student Satisfaction.
A proposal for teaching innovation is proposed with the topic of "perinatal grief" very little studied and taught in degrees such as medicine, nursing and psychology, with scientific evidence demonstrating a knowledge deficit on the part of healthcare professionals.
Read the detailed description
A proposal for teaching innovation is proposed with the topic of "perinatal grief" very little studied and taught in degrees such as medicine, nursing and psychology, with scientific evidence demonstrating a knowledge deficit on the part of healthcare professionals. With the aim of improving this knowledge and the communication skills of the students who are taught, the objective is to introduce perinatal grief so that the level of knowledge on this topic increases and also increases their communication abilities in this aspect, being a very difficult topic to cover if you do not have training. To carry out teaching innovation, it is proposed, in addition to a master class to impart theoretical knowledge, to innovate by carrying out clinical simulation among students and through a questionnaire to evaluate whether this type of technique is effective for the acquisition of knowledge, skills to provide support. , improve self-awareness and also assess student satisfaction.
- Conditions
- Perinatal Death, Perinatal Grief, Teaching Innovation
- Being tested
- Educative intervention
- Keywords
- Perinatal Death, Grief, Teaching Innovation, Clinical simulation
- Medical subject headings
- Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educative interventionOther
Also called Formative intervention
an activity for simulation-based learning First, a theoretical session was carried out in order to acquire theoretical knowledge, skills to provide support for perinatal grief, and improve self-awareness. Prior to this, a pre-questionnaire was carried out in order to previously evaluate these aspects.
Subsequently, a first session was held to make contact with the simulation, teach the scenarios, material, etc. After this, two questionnaires were passed: one related to the acquisition of knowledge, skills to provide support, self-awareness and another on the students' satisfaction with the simulation.
| Study group | Role | What they receive |
|---|---|---|
| Educative intervention | Other | A first theoretical session was carried out in order to acquire theoretical knowledge, skills to provide support for perinatal grief, and improve self-awareness. Prior to this, a pre-questionnaire was carried out in order to previously evaluate these aspects.
Subsequently, a first session was held to make contact with the simulation, teach the scenarios, material, etc. This session would be the prebriefing. After this session, the complete simulation, with subsequent evaluation of it giving feedback to the students (debriefing). After this, two questionnaires were passed: one related to the acquisition of knowledge, skills to provide support, self-awareness and another on the students' satisfaction with the simulation. Receives: Other: Educative intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesure if simulation techniques are effective in helping to acquire knowledge about perinatal grief in nursing degree students.
Rate the knowledge acquired
Measured: 3 months
Mesure if simulation techniques are effective in acquiring support skills and improving self-awareness about perinatal grief in nursing degree students.
Rate the effectiveness of simulation techniques
Measured: 3 months
Determine the degree of satisfaction of nursing degree students with the simulation learning of how to approach perinatal grief.
Satisfaction questionnaire with the activity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Mar 2023
- Primary completion30 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DeathStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is an activity for simulation-based learning.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169423
- Sponsor's protocol ID
- JAUI_NUR_1
- Status last verified
- Nov 2024
- First submitted
- 23 Oct 2023
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If it is possible to publish in scientific journals related to the topic described, the results will be disseminated.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation of Perinatal Grief. Assessment of Knowledge Acquisition, Support Skills, Self-awareness and Student Satisfaction.
- ClinicalTrials.gov ID
- NCT06169423
- Acronym / sponsor ID
- JAUI_NUR_1
- Conditions
- Perinatal Death, Perinatal Grief, Teaching Innovation
- Keywords
- Perinatal Death, Grief, Teaching Innovation, Clinical simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Dec 2023 (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.
A proposal for teaching innovation is proposed with the topic of "perinatal grief" very little studied and taught in degrees such as medicine, nursing and psychology, with scientific evidence demonstrating a knowledge deficit on the part of healthcare professionals.
Detailed description
A proposal for teaching innovation is proposed with the topic of "perinatal grief" very little studied and taught in degrees such as medicine, nursing and psychology, with scientific evidence demonstrating a knowledge deficit on the part of healthcare professionals. With the aim of improving this knowledge and the communication skills of the students who are taught, the objective is to introduce perinatal grief so that the level of knowledge on this topic increases and also increases their communication abilities in this aspect, being a very difficult topic to cover if you do not have training. To carry out teaching innovation, it is proposed, in addition to a master class to impart theoretical knowledge, to innovate by carrying out clinical simulation among students and through a questionnaire to evaluate whether this type of technique is effective for the acquisition of knowledge, skills to provide support. , improve self-awareness and also assess student satisfaction.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an activity for simulation-based learning.
| Arm | Type | Receives |
|---|---|---|
| Educative intervention | Other | Other: Educative interventionA first theoretical session was carried out in order to acquire theoretical knowledge, skills to provide support for perinatal grief, and improve self-awareness. Prior to this, a pre-questionnaire was carried out in order to previously evaluate these aspects. Subsequently, a first session was held to make contact with the simulation, teach the scenarios, material, etc. This session would be the prebriefing. After this session, the complete simulation, with subsequent evaluation of it giving feedback to the students (debriefing). After this, two questionnaires were passed: one related to the acquisition of knowledge, skills to provide support, self-awareness and another on the students' satisfaction with the simulation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Educative interventionAlso: Formative interventionan activity for simulation-based learning First, a theoretical session was carried out in order to acquire theoretical knowledge, skills to provide support for perinatal grief, and improve self-awareness. Prior to this, a pre-questionnaire was carried out in order to previously evaluate these aspects. Subsequently, a first session was held to make contact with the simulation, teach the scenarios, material, etc. After this, two questionnaires were passed: one related to the acquisition of knowledge, skills to provide support, self-awareness and another on the students' satisfaction with the simulation. | Other | Educative intervention |
Primary outcome
Mesure if simulation techniques are effective in helping to acquire knowledge about perinatal grief in nursing degree students.
Time frame: 3 months
Rate the knowledge acquired
Mesure if simulation techniques are effective in acquiring support skills and improving self-awareness about perinatal grief in nursing degree students.
Time frame: 3 months
Rate the effectiveness of simulation techniques
Determine the degree of satisfaction of nursing degree students with the simulation learning of how to approach perinatal grief.
Time frame: 3 months
Satisfaction questionnaire with the activity
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 Nov 2024.
- Individual participant dataSharing planned: Yes. If it is possible to publish in scientific journals related to the topic described, the results will be disseminated.
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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.
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 Educative intervention in people with Perinatal Death and Perinatal Grief, run by Universitat Jaume I at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Nov 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 Spain. 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?
Mesure if simulation techniques are effective in helping to acquire knowledge about perinatal grief in nursing degree students. (time frame: 3 months). The study lists 3 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 Nov 2024; AzTrials last refreshed its copy on 4 Nov 2026.