EducationNCT01792674
'In Situ Simulation' Versus 'Off Site Simulation' in Obstetric Emergencies
A study testing In situ simulation and Off site simulation in people with Education and Obstetrics, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Care for pregnant is a field where unexpected emergencies occur, however emergencies are rare and hence competences difficult to learn. Therefore, it can be relevant to use simulation-based medical education. Many questions on how simulation can optimise learning remain unanswered. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Education, Obstetrics, Simulation
- What is being tested?
- In situ simulation and Off site simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to Oct 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health-care professionals (specialised obstetricians, trainee obstetricians, midwifes, auxiliary nurses, specialised anaesthetists, trainee anaesthetists, anaesthesia nurses, and surgical nurses) employed at the Obstetric or Anaesthesia departments at Rigshospitalet and trainee doctors having part of their training programme at Juliane Marie Centre for children, women and reproduction, Rigshospitalet.
- Participants shall work in the evening-, night- and weekend-shift duties with some of their work in labour ward
- Provide signed informed consent before randomisation
Who cannot join
- Manager with staff responsibilities. Staff taking part in planning of the intervention.
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Juliane Marie Centre for Children, Women and Reproduction
Copenhagen, 2100
About this study
Official title: A Randomised Educational Feasibility Trial: 'In Situ Simulation' Versus 'Off Site Simulation' in Obstetric Emergencies and the Effect on Knowledge, Safety-attitudes, Team Performance, Stress, and Motivation
Care for pregnant is a field where unexpected emergencies occur, however emergencies are rare and hence competences difficult to learn. Therefore, it can be relevant to use simulation-based medical education. Many questions on how simulation can optimise learning remain unanswered. A major question is how simulation settings as 'in situ simulation' (i.e. in the actual patient care unit) versus 'off site simulation' (i.e. in training rooms or simulation center) impact learning.
Objectives: To study the effect of 'in situ simulation' versus 'off site simulation' on learning outcome, safety-attitudes, team performance and clinical performance in the simulated setting plus stress and motivational inducing effect of simulation settings.
Read more
Design: Randomised trial. Primary outcome: Written knowledge-test. Exploratory outcomes: Safety Attitudes Questionnaire, team- and clinical performance score, validated stress inventory, salivary cortisol, Intrinsic Motivation Inventory and questionnaire on perceptions of the simulation and organisational changes needed.
Perspective: To provide new knowledge on contextual effects of different simulation settings.
Read the detailed description
Background: Care for pregnant and delivering women is a field where unexpected emergencies, as for example emergency caesarean sectio, postpartum bleeding or severe preeclampsia, that may potentially harm both mother and baby, occur. Obstetric emergencies are rare and hence by nature difficult to learn in real life. Therefore, it can be relevant with simulation-based medical education, i.e., training with mannequins and scenarios. In non-systematic reviews it is concluded that repetitive medical simulations are associated with improved learner outcomes. However, many questions on how simulation can optimise learning in emergencies remain unanswered; e.g., how different kinds of simulation settings as 'in situ simulation' versus 'off site simulation' impact learning at the individual and the team level.
Objectives: In a randomised trial on authentic obstetric-anaesthesia teams to study the effect of 'in situ simulation' versus 'off site simulation' on participants learning outcome, safety-attitudes, team performance plus motivational and stress inducing effect of different simulation settings and the potential association with learning and performance.
Interventions: The experimental intervention is training in 'in situ simulation' which means training in the actual patient care unit, in this situation the labour suite and operation theatre. The control group will receive the same training 'off site simulation', i.e., in training rooms away from the actual patient care unit. In the two different simulation settings, the same scenarios will be conducted and the participants will comprise of authentic teams of specialised obstetricians or obstetric trainees in their final training year, trainee obstetricians, midwifes, auxiliary nurses, specialised anaesthetists or anaesthesia trainees in their final training year, trainee anaesthetists, anaesthesia nurses, and surgical nurses.
Design and trial size: Single-centre investigator-initiated randomised superiority trial. We have chosen to calculate the required sample size based on experiences about knowledge tests. We assume a standard deviation at 24%, and a difference in the experimental and control means at 17%. With alpha set at 0.05, beta set at 0.80 and intraclass correlation at 0,05 the sample size added up to 93 participants. It is planned to include 100 participants.
Outcomes: Primary outcome: 1) Knowledge by written test as multiple choice questions.
Exploratory outcomes: 1) Safety Attitudes Questionnaire SAQ). 2) Team performance score measured by Team Emergency Assessment Measure (TEAM). 3) Clinical performance in the simulated setting. 4) Salivary cortisol. 5) Validated stress inventory (Stress-Trait Anxiety Inventory (STAI-1) and cognitive appraisal). 6) Intrinsic Motivation Inventory (IMI). 7) Questionnaire to evaluate participants' perceptions of the simulation, the debriefing, and changes needed at the organisational level.
Time schedule: 2 years with start planning 1st of April 2012. Randomisation will start after approval from the Regional Ethics Committee and the Danish Data Protection Agency. The intervention with 'in situ simulation' versus 'on site simulation' described in this protocol will be scheduled spring 2013.
- Conditions
- Education, Obstetrics, Simulation, 'In Situ Simulation'
- Being tested
- In situ simulation, Off site simulation
- Keywords
- Education, Patient simulation, In situ simulation, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In situ simulationOther
Off site simulationOther
| Study group | Role | What they receive |
|---|---|---|
| In situ simulation | Experimental | 'In situ simulation' which is training in the actual patient care unit, in this situation the labour suite and operation theatre Receives: Other: In situ simulation |
| Off site simulation | Active comparator | The control group will receive the same training 'off site simulation', i.e., in training rooms away from the actual patient care unit. Receives: Other: Off site simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge test by written test as multiple-choice questions (MCQ).
The intervention will be applied on ten training days. Each training day will include training of one authentic team consisting of ten health care professionals.
Measured: The participants will get a knowledge test at the training day they will participate in. Ten training days will be conducted in a 3 months period
Secondary outcomes (8)
Exploratory outcomes: Safety Attitudes Questionnaire (SAQ).
Safety Attitudes Questionnaire (SAQ) is an inventory used in several countries. Safety Attitudes Questionnaire (SAQ) is an exploratory outcomes.
Measured: The participants will answer the Safety Attitudes Questionnaire (SAQ) 3-6 weeks before and 3-6 weeks after the training day they will participate in. Ten training days will be conducted in a 3 months period.
Exploratory outcomes: Team Emergency Assessment Measure (TEAM).
Team performance score measured by Team Emergency Assessment Measure (TEAM) will be assessed by independent observers by reviewing video recordings of the scenarios. A validated rating scale (Cooper S, 2010) will be used. Team Emergency Assessment Measure (TEAM) is an exploratory outcomes.
Measured: Video's will be recorded at the ten training days (within a 3 months period) and within approximately 4 months after the video's will be assessed by independent observers.
Exploratory outcomes: Video assessment: Clinical performance in the simulated setting.
Clinical performance in the simulated setting will be assessed by independent observers by reviewing video recordings of the simulations. The assessment will be based on international and national guidelines of best medical practice. Clinical performance in the simulated setting is an exploratory outcomes.
Measured: Video's will be recorded at the ten training days (within a 3 months period) and within approximately 4 months after be assessed by independent observers.
Exploratory outcome: Salivary cortisol
Salivary cortisol is an exploratory outcome
Measured: Participants will have testing for salivary cortisol before and after the two simulated scenarios that will be conducted on the training they will participate in.
Exploratory outcome: State-Trait Anxiety Inventory (STAI-1).
State-Trait Anxiety Inventory (STAI-1) is a validated stress inventory. State-Trait Anxiety Inventory (STAI-1) is an exploratory outcome.
Measured: Participants will respond on State-Trait Anxiety Inventory (STAI-1) before and after the two simulated scenarios that will be conducted on the training day they will participate in.
Exploratory outcome: Cognitive appraisal (CA).
Cognitive appraisal (CA) is applied on 10-point Likert scales to get information of the participants perceived stress of the upcoming event along with their capacity to cope with the stressor. Cognitive appraisal (CA) is an exploratory outcome.
Measured: Participants will respond on cognitive appraisal (CA) before and after the two simulated scenarios that will be conducted on the training day they will participate in on one training day.
Exploratory outcome: Intrinsic Motivation Inventory (IMI).
Intrinsic Motivation Inventory (IMI) is a validated inventory.Intrinsic Motivation Inventory (IMI) is an exploratory outcome.
Measured: The participants will answer on Intrinsic Motivation Inventory (IMI) approximately one week after the training day they will have participated in
Exploratory outcome: Participant's perceptions of the simulations.
Participant's perceptions of the simulations will be obtained on questionnaires including questions on Likert scales and few open questions about personal perceptions of the simulations and whether the simulations inspired to changes in the organisation.
Measured: The participants will answer on questionnaires about their perceptions of the simulations approximately one week after the training day they will have participated in.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EducationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Responsible party
- Principal investigator, Jette Led Sorensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jette Led Sørensen, MD, MMEd, Principal investigator, Juliane Marie Centre for Children, Women and Reproduction , Rigshospitalet, Copenhagen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792674
- Sponsor's protocol ID
- ob-an-op-simulation-trial
- Status last verified
- Dec 2015
- First submitted
- 30 Jan 2013
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fransen AF, van de Ven J, Banga FR, Mol BWJ, Oei SG. Multi-professional simulation-based team training in obstetric emergencies for improving patient outcomes and trainees' performance. Cochrane Database Syst Rev. 2020 Dec 16;12(12):CD011545. doi: 10.1002/14651858.CD011545.pub2.
PubMed 33325570Sorensen JL, van der Vleuten C, Rosthoj S, Ostergaard D, LeBlanc V, Johansen M, Ekelund K, Starkopf L, Lindschou J, Gluud C, Weikop P, Ottesen B. Simulation-based multiprofessional obstetric anaesthesia training conducted in situ versus off-site leads to similar individual and team outcomes: a randomised educational trial. BMJ Open. 2015 Oct 6;5(10):e008344. doi: 10.1136/bmjopen-2015-008344.
PubMed 26443654Sorensen JL, Van der Vleuten C, Lindschou J, Gluud C, Ostergaard D, LeBlanc V, Johansen M, Ekelund K, Albrechtsen CK, Pedersen BW, Kjaergaard H, Weikop P, Ottesen B. 'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation: study protocol for a randomized controlled trial. Trials. 2013 Jul 17;14:220. doi: 10.1186/1745-6215-14-220.
PubMed 23870501
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Educational Feasibility Trial: 'In Situ Simulation' Versus 'Off Site Simulation' in Obstetric Emergencies and the Effect on Knowledge, Safety-attitudes, Team Performance, Stress, and Motivation
- ClinicalTrials.gov ID
- NCT01792674
- Acronym / sponsor ID
- ob-an-op-simulation-trial
- Conditions
- Education, Obstetrics, Simulation, 'In Situ Simulation'
- Keywords
- Education, Patient simulation, In situ simulation, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Feb 2013 (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.
Care for pregnant is a field where unexpected emergencies occur, however emergencies are rare and hence competences difficult to learn. Therefore, it can be relevant to use simulation-based medical education. Many questions on how simulation can optimise learning remain unanswered. A major question is how simulation settings as 'in situ simulation' (i.e. in the actual patient care unit) versus 'off site simulation' (i.e. in training rooms or simulation center) impact learning.
Objectives: To study the effect of 'in situ simulation' versus 'off site simulation' on learning outcome, safety-attitudes, team performance and clinical performance in the simulated setting plus stress and motivational inducing effect of simulation settings.
Design: Randomised trial. Primary outcome: Written knowledge-test. Exploratory outcomes: Safety Attitudes Questionnaire, team- and clinical performance score, validated stress inventory, salivary cortisol, Intrinsic Motivation Inventory and questionnaire on perceptions of the simulation and organisational changes needed.
Perspective: To provide new knowledge on contextual effects of different simulation settings.
Detailed description
Background: Care for pregnant and delivering women is a field where unexpected emergencies, as for example emergency caesarean sectio, postpartum bleeding or severe preeclampsia, that may potentially harm both mother and baby, occur. Obstetric emergencies are rare and hence by nature difficult to learn in real life. Therefore, it can be relevant with simulation-based medical education, i.e., training with mannequins and scenarios. In non-systematic reviews it is concluded that repetitive medical simulations are associated with improved learner outcomes. However, many questions on how simulation can optimise learning in emergencies remain unanswered; e.g., how different kinds of simulation settings as 'in situ simulation' versus 'off site simulation' impact learning at the individual and the team level.
Objectives: In a randomised trial on authentic obstetric-anaesthesia teams to study the effect of 'in situ simulation' versus 'off site simulation' on participants learning outcome, safety-attitudes, team performance plus motivational and stress inducing effect of different simulation settings and the potential association with learning and performance.
Interventions: The experimental intervention is training in 'in situ simulation' which means training in the actual patient care unit, in this situation the labour suite and operation theatre. The control group will receive the same training 'off site simulation', i.e., in training rooms away from the actual patient care unit. In the two different simulation settings, the same scenarios will be conducted and the participants will comprise of authentic teams of specialised obstetricians or obstetric trainees in their final training year, trainee obstetricians, midwifes, auxiliary nurses, specialised anaesthetists or anaesthesia trainees in their final training year, trainee anaesthetists, anaesthesia nurses, and surgical nurses.
Design and trial size: Single-centre investigator-initiated randomised superiority trial. We have chosen to calculate the required sample size based on experiences about knowledge tests. We assume a standard deviation at 24%, and a difference in the experimental and control means at 17%. With alpha set at 0.05, beta set at 0.80 and intraclass correlation at 0,05 the sample size added up to 93 participants. It is planned to include 100 participants.
Outcomes: Primary outcome: 1) Knowledge by written test as multiple choice questions.
Exploratory outcomes: 1) Safety Attitudes Questionnaire SAQ). 2) Team performance score measured by Team Emergency Assessment Measure (TEAM). 3) Clinical performance in the simulated setting. 4) Salivary cortisol. 5) Validated stress inventory (Stress-Trait Anxiety Inventory (STAI-1) and cognitive appraisal). 6) Intrinsic Motivation Inventory (IMI). 7) Questionnaire to evaluate participants' perceptions of the simulation, the debriefing, and changes needed at the organisational level.
Time schedule: 2 years with start planning 1st of April 2012. Randomisation will start after approval from the Regional Ethics Committee and the Danish Data Protection Agency. The intervention with 'in situ simulation' versus 'on site simulation' described in this protocol will be scheduled spring 2013.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In situ simulation | Experimental | Other: In situ simulation'In situ simulation' which is training in the actual patient care unit, in this situation the labour suite and operation theatre |
| Off site simulation | Active comparator | Other: Off site simulationThe control group will receive the same training 'off site simulation', i.e., in training rooms away from the actual patient care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Health-care professionals (specialised obstetricians, trainee obstetricians, midwifes, auxiliary nurses, specialised anaesthetists, trainee anaesthetists, anaesthesia nurses, and surgical nurses) employed at the Obstetric or Anaesthesia departments at Rigshospitalet and trainee doctors having part of their training programme at Juliane Marie Centre for children, women and reproduction, Rigshospitalet.
- Participants shall work in the evening-, night- and weekend-shift duties with some of their work in labour ward
- Provide signed informed consent before randomisation
Key exclusion criteria (2 listed)
- Manager with staff responsibilities. Staff taking part in planning of the intervention.
- Lack of informed consent
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 |
|---|---|---|
| In situ simulation | Other | In situ simulation |
| Off site simulation | Other | Off site simulation |
Primary outcome
Knowledge test by written test as multiple-choice questions (MCQ).
Time frame: The participants will get a knowledge test at the training day they will participate in. Ten training days will be conducted in a 3 months period
The intervention will be applied on ten training days. Each training day will include training of one authentic team consisting of ten health care professionals.
8 secondary outcomes
Exploratory outcomes: Safety Attitudes Questionnaire (SAQ).
Time frame: The participants will answer the Safety Attitudes Questionnaire (SAQ) 3-6 weeks before and 3-6 weeks after the training day they will participate in. Ten training days will be conducted in a 3 months period.
Exploratory outcomes: Team Emergency Assessment Measure (TEAM).
Time frame: Video's will be recorded at the ten training days (within a 3 months period) and within approximately 4 months after the video's will be assessed by independent observers.
Exploratory outcomes: Video assessment: Clinical performance in the simulated setting.
Time frame: Video's will be recorded at the ten training days (within a 3 months period) and within approximately 4 months after be assessed by independent observers.
Exploratory outcome: Salivary cortisol
Time frame: Participants will have testing for salivary cortisol before and after the two simulated scenarios that will be conducted on the training they will participate in.
Exploratory outcome: State-Trait Anxiety Inventory (STAI-1).
Time frame: Participants will respond on State-Trait Anxiety Inventory (STAI-1) before and after the two simulated scenarios that will be conducted on the training day they will participate in.
Exploratory outcome: Cognitive appraisal (CA).
Time frame: Participants will respond on cognitive appraisal (CA) before and after the two simulated scenarios that will be conducted on the training day they will participate in on one training day.
Exploratory outcome: Intrinsic Motivation Inventory (IMI).
Time frame: The participants will answer on Intrinsic Motivation Inventory (IMI) approximately one week after the training day they will have participated in
Exploratory outcome: Participant's perceptions of the simulations.
Time frame: The participants will answer on questionnaires about their perceptions of the simulations approximately one week after the training day they will have participated in.
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 18 Dec 2015.
- Derived from this study: PubMed 33325570Fransen AF, van de Ven J, Banga FR, Mol BWJ, Oei SG. Multi-professional simulation-based team training in obstetric emergencies for improving patient outcomes and trainees' performance. Cochrane Database Syst Rev. 2020 Dec 16;12(12):CD011545. doi: 10.1002/14651858.CD011545.pub2.
- Derived from this study: PubMed 26443654Sorensen JL, van der Vleuten C, Rosthoj S, Ostergaard D, LeBlanc V, Johansen M, Ekelund K, Starkopf L, Lindschou J, Gluud C, Weikop P, Ottesen B. Simulation-based multiprofessional obstetric anaesthesia training conducted in situ versus off-site leads to similar individual and team outcomes: a randomised educational trial. BMJ Open. 2015 Oct 6;5(10):e008344. doi: 10.1136/bmjopen-2015-008344.
- Derived from this study: PubMed 23870501Sorensen JL, Van der Vleuten C, Lindschou J, Gluud C, Ostergaard D, LeBlanc V, Johansen M, Ekelund K, Albrechtsen CK, Pedersen BW, Kjaergaard H, Weikop P, Ottesen B. 'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation: study protocol for a randomized controlled trial. Trials. 2013 Jul 17;14:220. doi: 10.1186/1745-6215-14-220.
- Related InfoLink provided by the sponsor.
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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.
Jette Led Sørensen, MD, MMEd principal investigator
Juliane Marie Centre for Children, Women and Reproduction , Rigshospitalet, Copenhagen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In situ simulation and Off site simulation in people with Education and Obstetrics, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 18 Dec 2015. 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 Denmark. 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?
Knowledge test by written test as multiple-choice questions (MCQ). (time frame: The participants will get a knowledge test at the training day they will participate in. Ten training days will be conducted in a 3 months period). 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 NCT01792674, which also lists 3 linked publications.
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 18 Dec 2015.