Forensic NursingNCT05932108
Evaluation of the Violence Prevention Initiative TERMA in Forensic Psychiatric Inpatient Care
An observational study of Forensic Nursing and Forensic Psychiatry, run by Vastra Gotaland Region.
Trial summary
The aim of this project is to evaluate the violence prevention method Therapeutic meeting with aggression (TERMA) regarding adverse events and perceived safety by patients and staff within forensic psychiatric inpatient care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Forensic Nursing, Forensic Psychiatry
- What is being tested?
- Education in TERMA and Changed work routines based on TERMA
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2023to 25 Sep 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Staff at a forensic psychiatry department. Patients at a forensic psychiatry departmen
Who may be able to join
- ≥ 18 years of age who
- work in forensic psychiatric inpatient care,
- understand and speak Swedish or English, and are
- willing to participate and sign a consent form.
- ≥ 18 years of age who are
- admitted to forensic psychiatric inpatient care according to the Swedish Forensic Psychiatric Care Act,
Show all 9Show fewer
- understand and speak Swedish or English,
- have approval to participate from the treating physician, and are
- willing to participate and sign a consent form.
Who cannot join
- not willing to participate
- not willing to participate
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this project is to evaluate the violence prevention method Therapeutic meeting with aggression (TERMA) regarding adverse events and perceived safety by patients and staff within forensic psychiatric inpatient care. Additionally, the project will investigate whether the organizational culture influences the implementation of the TERMA method and the experiences of patients and staff in situations involving threats, violence, and the use of coercive measures.
Read the detailed description
Overall aim The aim of this project is to evaluate the violence prevention method Therapeutic meeting with aggression (TERMA) regarding adverse events and perceived safety by patients and staff within forensic psychiatric inpatient care. Additionally, the project will investigate whether the organizational culture influences the implementation of the TERMA method and the experiences of patients and staff in situations involving threats, violence, and the use of coercive measures.
Research questions
- To what extent does the implementation of TERMA impact the perceived safety of staff and patients in a forensic psychiatric inpatient setting, as measured by the Perceived Safety Questionnaire (E13)?
- What is the effect of implementing TERMA on the frequency of incidents of aggression and violence, healthcare and occupational injuries, and the use of coercive measures in a forensic psychiatric inpatient setting?
- How does the implementation of TERMA impact the organizational culture of a forensic psychiatric inpatient unit, as measured by changes in perceived safety, incidents of aggression and violence, healthcare and occupational injuries, and the use of coercive measures, as assessed by the Organisations Value Questionnaire (OVQ) questionnaire?
- How do patients perceive threatening and violent situations, exposure to coercive measures, and the implementation of TERMA in a forensic psychiatric inpatient setting?
- What are the attitudes and perceptions of staff towards working with TERMA, how do they respond to threatening and violent situations, and what is the impact of these factors on the work environment in a forensic psychiatric inpatient setting? Introduction Forensic psychiatric care is provided to patients who have been convicted of a crime that was perpetrated while having a severe mental disorder. Severe mental illness is a judicial concept within Swedish law and is not a medical diagnosis. The primary goal of forensic psychiatric care is to rehabilitate the patients so they can be reintegrated into society without risk of committing new crimes. Swedish law states that health care should strive to protect and strengthen the integrity and participation of the patient. This is, however, difficult within forensic psychiatric care, which is not voluntarily, involves mandatory treatment and deprives patients of liberty. Maintaining a therapeutic relationship with patients, while managing their reactions and emotions in high-security wards, can be challenging.
Forensic psychiatric patients are a heterogeneous group, given their various psycho pathologies, criminal histories and risk factors for reoffending. Patients sentenced to forensic psychiatric care are under involuntary care for long periods of time and rehabilitation length of 5-6 years are not unusual. Aggressive and violent behavior among patients is a prevalent occurrence in forensic psychiatry and a hindrance for successful rehabilitation. The complex composition of mental illnesses contributes to an experience of an insecure environment for both patients and healthcare personnel.
There is a need for research on the content and effects of managing aggression and violence. Several methods have been developed to manage and prevent such behaviors. One such method is the Therapeutic Meeting with Aggression (TERMA). It has previously been implemented in inpatient forensic psychiatric care in Sweden but further research is needed in evaluating its usefulness.
Therapeutic meeting with aggression (TERMA) TERMA was developed from the Norwegian Bergen model, with modifications made to align with the Swedish healthcare and legal systems. The primary aim of TERMA is to prevent aggression and violence through a system of low-effective treatment that is divided into escalating levels based on the patient's aggression level, risk of violence, and acts of violence. The TERMA model focuses on treatment, communication, and management of compassionate healthcare in forensic psychiatric settings. The levels of the TERMA model are in a "cascading" order, whereby if the treatment and management of one level are ineffective, the next level is initiated, and so on. The primary level involves the daily behavior and health status of the patient. The secondary level involves risk assessment and violence management, with a focus on creating an understanding of the situation for both the patient and healthcare workers. The tertiary level is utilized when violence cannot be avoided. Each level corresponds to a specific response according to the demands of the situation and environment.
- Conditions
- Forensic Nursing, Forensic Psychiatry
- Being tested
- Education in TERMA, Changed work routines based on TERMA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education in TERMABehavioural
Education of staff in TERMA. The primary aim of TERMA is to prevent aggression and violence through a system of low-effective treatment that is divided into escalating levels based on the patient's aggression level, risk of violence, and acts of violence . The TERMA model focuses on treatment, communication, and management of compassionate healthcare in forensic psychiatric settings . The levels of the TERMA model are in a "cascading" order, whereby if the treatment and management of one level are ineffective, the next level is initiated, and so on. The primary level involves the daily behavior and health status of the patient. The secondary level involves risk assessment and violence management, with a focus on creating an understanding of the situation for both the patient and healthcare workers. The tertiary level is utilized when violence cannot be avoided . Each level corresponds to a specific response according to the demands of the situation and environment.
Changed work routines based on TERMAOther
NO planned intervention but staff work routines and behavior may change after their education in TERMA. Patients are exposed to these changes.
| Study group | Role | What they receive |
|---|---|---|
| Staff | Educational intervention in TERMA. All staff are required to attend the education. Receives: Behavioral: Education in TERMA | |
| Patients | Patients will not attend any education in TERMA. Data will be collected before and after the staffs education to se if the patients think the attitude of the staff have changed. Receives: Other: Changed work routines based on TERMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Safety Questionnaire (E13)
Questionnaire data on perceived safety. E13 measures factors such as self-estimated safety, feeling of safety, acts of violence and coercion, reaction and aggression measurements and cause of aggression in the wards. The questionnaire consists of 13 statements whose agreement is answered on a four-point Likert scale from completely agree to completely disagree. Minimum value=13, maximum value=52, higher values means better outcome.
Measured: Change measure (baseline to 6 months)
Perceived Safety Questionnaire (E13)
Questionnaire data on perceived safety. E13 measures factors such as self-estimated safety, feeling of safety, acts of violence and coercion, reaction and aggression measurements and cause of aggression in the wards. The questionnaire consists of 13 statements whose agreement is answered on a four-point Likert scale from completely agree to completely disagree. Minimum value=13, maximum value=52, higher values means better outcome.
Measured: Change measure (baseline to 1 year)
Secondary outcomes (11)
Organisations Value Questionnaire (OVQ).
Questionnaire data on organizational culture. OVQ is used to measure the the overall organizational culture and dimensions human relation (HR), open systems (OS), rational goal (RG) and internal process (IP). It consisted of 52 items with alternative answers of the Likert type ranging from "strongly disagree" to "strongly agree". Averages were calculated for the total OVQ and for each subscale; a high score indicates strong disagreement. Minimum value 52, maximum value 520 for the total OVQ. Minimum value 13, maximum value 130 for each of the subscales.
Measured: Change measure (baseline to 6 months)
Organisations Value Questionnaire (OVQ).
Questionnaire data on organizational culture. OVQ is used to measure the the overall organizational culture and dimensions human relation (HR), open systems (OS), rational goal (RG) and internal process (IP). It consisted of 52 items with alternative answers of the Likert type ranging from "strongly disagree" to "strongly agree". Averages were calculated for the total OVQ and for each subscale; a high score indicates strong disagreement. Minimum value 52, maximum value 520 for the total OVQ. Minimum value 13, maximum value 130 for each of the subscales.
Measured: Change measure (baseline to 1 year)
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Correlation between organizational culture and perceived safety. OVQ is used to measure the the overall organizational culture and dimensions human relation (HR), open systems (OS), rational goal (RG) and internal process (IP). It consisted of 52 items with alternative answers of the Likert type ranging from "strongly disagree" to "strongly agree". Averages were calculated for the total OVQ and for each subscale; a high score indicates strong disagreement. Minimum value 52, maximum value 520 for the total OVQ. Minimum value 13, maximum value 130 for each of the subscales.
E13 measures factors such as self-estimated safety, feeling of safety, acts of violence and coercion, reaction and aggression measurements and cause of aggression in the wards. The questionnaire consists of 13 statements whose agreement is answered on a four-point Likert scale from completely agree to completely disagree. Minimum value=13, maximum value=52, higher values means better outcome.
Measured: Baseline
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Correlation between organizational culture and perceived safety. OVQ is used to measure the the overall organizational culture and dimensions human relation (HR), open systems (OS), rational goal (RG) and internal process (IP). It consisted of 52 items with alternative answers of the Likert type ranging from "strongly disagree" to "strongly agree". Averages were calculated for the total OVQ and for each subscale; a high score indicates strong disagreement. Minimum value 52, maximum value 520 for the total OVQ. Minimum value 13, maximum value 130 for each of the subscales.
E13 measures factors such as self-estimated safety, feeling of safety, acts of violence and coercion, reaction and aggression measurements and cause of aggression in the wards. The questionnaire consists of 13 statements whose agreement is answered on a four-point Likert scale from completely agree to completely disagree. Minimum value=13, maximum value=52, higher values means better outcome.
Measured: 6 months
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Correlation between organizational culture and perceived safety. OVQ is used to measure the the overall organizational culture and dimensions human relation (HR), open systems (OS), rational goal (RG) and internal process (IP). It consisted of 52 items with alternative answers of the Likert type ranging from "strongly disagree" to "strongly agree". Averages were calculated for the total OVQ and for each subscale; a high score indicates strong disagreement. Minimum value 52, maximum value 520 for the total OVQ. Minimum value 13, maximum value 130 for each of the subscales.
E13 measures factors such as self-estimated safety, feeling of safety, acts of violence and coercion, reaction and aggression measurements and cause of aggression in the wards. The questionnaire consists of 13 statements whose agreement is answered on a four-point Likert scale from completely agree to completely disagree. Minimum value=13, maximum value=52, higher values means better outcome.
Measured: 1 year
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Correlation between organizational culture and perceived safety. OVQ is used to measure the the overall organizational culture and dimensions human relation (HR), open systems (OS), rational goal (RG) and internal process (IP). It consisted of 52 items with alternative answers of the Likert type ranging from "strongly disagree" to "strongly agree". Averages were calculated for the total OVQ and for each subscale; a high score indicates strong disagreement. Minimum value 52, maximum value 520 for the total OVQ. Minimum value 13, maximum value 130 for each of the subscales.
E13 measures factors such as self-estimated safety, feeling of safety, acts of violence and coercion, reaction and aggression measurements and cause of aggression in the wards. The questionnaire consists of 13 statements whose agreement is answered on a four-point Likert scale from completely agree to completely disagree. Minimum value=13, maximum value=52, higher values means better outcome.
Measured: Baseline (OVQ) and 6 months (E13)
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Correlation between organizational culture and perceived safety. OVQ is used to measure the the overall organizational culture and dimensions human relation (HR), open systems (OS), rational goal (RG) and internal process (IP). It consisted of 52 items with alternative answers of the Likert type ranging from "strongly disagree" to "strongly agree". Averages were calculated for the total OVQ and for each subscale; a high score indicates strong disagreement. Minimum value 52, maximum value 520 for the total OVQ. Minimum value 13, maximum value 130 for each of the subscales.
E13 measures factors such as self-estimated safety, feeling of safety, acts of violence and coercion, reaction and aggression measurements and cause of aggression in the wards. The questionnaire consists of 13 statements whose agreement is answered on a four-point Likert scale from completely agree to completely disagree. Minimum value=13, maximum value=52, higher values means better outcome.
Measured: Baseline (OVQ) and 1 year (E13)
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Correlation between organizational culture and perceived safety. OVQ is used to measure the the overall organizational culture and dimensions human relation (HR), open systems (OS), rational goal (RG) and internal process (IP). It consisted of 52 items with alternative answers of the Likert type ranging from "strongly disagree" to "strongly agree". Averages were calculated for the total OVQ and for each subscale; a high score indicates strong disagreement. Minimum value 52, maximum value 520 for the total OVQ. Minimum value 13, maximum value 130 for each of the subscales.
E13 measures factors such as self-estimated safety, feeling of safety, acts of violence and coercion, reaction and aggression measurements and cause of aggression in the wards. The questionnaire consists of 13 statements whose agreement is answered on a four-point Likert scale from completely agree to completely disagree. Minimum value=13, maximum value=52, higher values means better outcome.
Measured: Baseline (OVQ) and change in E13 (baseline to 6 months)
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Correlation between organizational culture and perceived safety. OVQ is used to measure the the overall organizational culture and dimensions human relation (HR), open systems (OS), rational goal (RG) and internal process (IP). It consisted of 52 items with alternative answers of the Likert type ranging from "strongly disagree" to "strongly agree". Averages were calculated for the total OVQ and for each subscale; a high score indicates strong disagreement. Minimum value 52, maximum value 520 for the total OVQ. Minimum value 13, maximum value 130 for each of the subscales.
E13 measures factors such as self-estimated safety, feeling of safety, acts of violence and coercion, reaction and aggression measurements and cause of aggression in the wards. The questionnaire consists of 13 statements whose agreement is answered on a four-point Likert scale from completely agree to completely disagree. Minimum value=13, maximum value=52, higher values means better outcome.
Measured: Baseline (OVQ) and change in E13 (baseline to 1 year)
Number of coercive measures
Data from medical records on coercive measures, for example restraint and forced medication
Measured: From 1 year before baseline to 1 year after study end
Incidence of threat and violence
Deviation reports from the incidence report system "MedControl PRO"
Measured: From 1 year before baseline to 1 year after study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start15 Jul 2023 (estimated)
- Primary completion25 Feb 2024 (estimated)
- Study completion25 Sep 2024 (estimated)
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 Forensic NursingStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sara Wallström, PhD, Principal investigator, Västra Götalandsregionen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932108
- Sponsor's protocol ID
- TERMA
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data (IPD)
Publications
Doinakis P, Ali L, Sjodin AK, Andine P, Alexiou E, Wallstrom S. Effects of a Violence Prevention Intervention Therapeutic Meeting With Aggression in Forensic Psychiatric Inpatient Care: Protocol for an Observational Study. JMIR Res Protoc. 2025 Oct 9;14:e74295. doi: 10.2196/74295.
PubMed 41066754
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Violence Prevention Initiative TERMA in Forensic Psychiatric Inpatient Care
- ClinicalTrials.gov ID
- NCT05932108
- Acronym / sponsor ID
- TERMA
- Conditions
- Forensic Nursing, Forensic Psychiatry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 25 Feb 2024 (estimated)
- Study completion
- 25 Sep 2024 (estimated)
- First posted
- 6 Jul 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.
The aim of this project is to evaluate the violence prevention method Therapeutic meeting with aggression (TERMA) regarding adverse events and perceived safety by patients and staff within forensic psychiatric inpatient care. Additionally, the project will investigate whether the organizational culture influences the implementation of the TERMA method and the experiences of patients and staff in situations involving threats, violence, and the use of coercive measures.
Detailed description
Overall aim The aim of this project is to evaluate the violence prevention method Therapeutic meeting with aggression (TERMA) regarding adverse events and perceived safety by patients and staff within forensic psychiatric inpatient care. Additionally, the project will investigate whether the organizational culture influences the implementation of the TERMA method and the experiences of patients and staff in situations involving threats, violence, and the use of coercive measures.
Research questions
- To what extent does the implementation of TERMA impact the perceived safety of staff and patients in a forensic psychiatric inpatient setting, as measured by the Perceived Safety Questionnaire (E13)?
- What is the effect of implementing TERMA on the frequency of incidents of aggression and violence, healthcare and occupational injuries, and the use of coercive measures in a forensic psychiatric inpatient setting?
- How does the implementation of TERMA impact the organizational culture of a forensic psychiatric inpatient unit, as measured by changes in perceived safety, incidents of aggression and violence, healthcare and occupational injuries, and the use of coercive measures, as assessed by the Organisations Value Questionnaire (OVQ) questionnaire?
- How do patients perceive threatening and violent situations, exposure to coercive measures, and the implementation of TERMA in a forensic psychiatric inpatient setting?
- What are the attitudes and perceptions of staff towards working with TERMA, how do they respond to threatening and violent situations, and what is the impact of these factors on the work environment in a forensic psychiatric inpatient setting? Introduction Forensic psychiatric care is provided to patients who have been convicted of a crime that was perpetrated while having a severe mental disorder. Severe mental illness is a judicial concept within Swedish law and is not a medical diagnosis. The primary goal of forensic psychiatric care is to rehabilitate the patients so they can be reintegrated into society without risk of committing new crimes. Swedish law states that health care should strive to protect and strengthen the integrity and participation of the patient. This is, however, difficult within forensic psychiatric care, which is not voluntarily, involves mandatory treatment and deprives patients of liberty. Maintaining a therapeutic relationship with patients, while managing their reactions and emotions in high-security wards, can be challenging.
Forensic psychiatric patients are a heterogeneous group, given their various psycho pathologies, criminal histories and risk factors for reoffending. Patients sentenced to forensic psychiatric care are under involuntary care for long periods of time and rehabilitation length of 5-6 years are not unusual. Aggressive and violent behavior among patients is a prevalent occurrence in forensic psychiatry and a hindrance for successful rehabilitation. The complex composition of mental illnesses contributes to an experience of an insecure environment for both patients and healthcare personnel.
There is a need for research on the content and effects of managing aggression and violence. Several methods have been developed to manage and prevent such behaviors. One such method is the Therapeutic Meeting with Aggression (TERMA). It has previously been implemented in inpatient forensic psychiatric care in Sweden but further research is needed in evaluating its usefulness.
Therapeutic meeting with aggression (TERMA) TERMA was developed from the Norwegian Bergen model, with modifications made to align with the Swedish healthcare and legal systems. The primary aim of TERMA is to prevent aggression and violence through a system of low-effective treatment that is divided into escalating levels based on the patient's aggression level, risk of violence, and acts of violence. The TERMA model focuses on treatment, communication, and management of compassionate healthcare in forensic psychiatric settings. The levels of the TERMA model are in a "cascading" order, whereby if the treatment and management of one level are ineffective, the next level is initiated, and so on. The primary level involves the daily behavior and health status of the patient. The secondary level involves risk assessment and violence management, with a focus on creating an understanding of the situation for both the patient and healthcare workers. The tertiary level is utilized when violence cannot be avoided. Each level corresponds to a specific response according to the demands of the situation and environment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staff | – | Behavioral: Education in TERMAEducational intervention in TERMA. All staff are required to attend the education. |
| Patients | – | Other: Changed work routines based on TERMAPatients will not attend any education in TERMA. Data will be collected before and after the staffs education to se if the patients think the attitude of the staff have changed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Staff at a forensic psychiatry department. Patients at a forensic psychiatry departmen
Key inclusion criteria (9 listed)
- ≥ 18 years of age who
- work in forensic psychiatric inpatient care,
- understand and speak Swedish or English, and are
- willing to participate and sign a consent form.
- ≥ 18 years of age who are
Key exclusion criteria (2 listed)
- not willing to participate
- not willing to participate
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 |
|---|---|---|
| Education in TERMAEducation of staff in TERMA. The primary aim of TERMA is to prevent aggression and violence through a system of low-effective treatment that is divided into escalating levels based on the patient's aggression level, risk of violence, and acts of violence . The TERMA model focuses on treatment, communication, and management of compassionate healthcare in forensic psychiatric settings . The levels of the TERMA model are in a "cascading" order, whereby if the treatment and management of one level are ineffective, the next level is initiated, and so on. The primary level involves the daily behavior and health status of the patient. The secondary level involves risk assessment and violence management, with a focus on creating an understanding of the situation for both the patient and healthcare workers. The tertiary level is utilized when violence cannot be avoided . Each level corresponds to a specific response according to the demands of the situation and environment. | Behavioural | Staff |
| Changed work routines based on TERMANO planned intervention but staff work routines and behavior may change after their education in TERMA. Patients are exposed to these changes. | Other | Patients |
Primary outcome
Perceived Safety Questionnaire (E13)
Time frame: Change measure (baseline to 6 months)
Questionnaire data on perceived safety. E13 measures factors such as self-estimated safety, feeling of safety, acts of violence and coercion, reaction and aggression measurements and cause of aggression in the wards. The questionnaire consists of 13 statements whose agreement is answered on a four-point Likert scale from completely agree to completely disagree. Minimum value=13, maximum value=52, higher values means better outcome.
Perceived Safety Questionnaire (E13)
Time frame: Change measure (baseline to 1 year)
Questionnaire data on perceived safety. E13 measures factors such as self-estimated safety, feeling of safety, acts of violence and coercion, reaction and aggression measurements and cause of aggression in the wards. The questionnaire consists of 13 statements whose agreement is answered on a four-point Likert scale from completely agree to completely disagree. Minimum value=13, maximum value=52, higher values means better outcome.
11 secondary outcomes
Organisations Value Questionnaire (OVQ).
Time frame: Change measure (baseline to 6 months)
Organisations Value Questionnaire (OVQ).
Time frame: Change measure (baseline to 1 year)
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Time frame: Baseline
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Time frame: 6 months
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Time frame: 1 year
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Time frame: Baseline (OVQ) and 6 months (E13)
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Time frame: Baseline (OVQ) and 1 year (E13)
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Time frame: Baseline (OVQ) and change in E13 (baseline to 6 months)
Organisations Value Questionnaire (OVQ)_Safety Questionnaire (E13)
Time frame: Baseline (OVQ) and change in E13 (baseline to 1 year)
Number of coercive measures
Time frame: From 1 year before baseline to 1 year after study end
Incidence of threat and violence
Time frame: From 1 year before baseline to 1 year after study end
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Derived from this study: PubMed 41066754Doinakis P, Ali L, Sjodin AK, Andine P, Alexiou E, Wallstrom S. Effects of a Violence Prevention Intervention Therapeutic Meeting With Aggression in Forensic Psychiatric Inpatient Care: Protocol for an Observational Study. JMIR Res Protoc. 2025 Oct 9;14:e74295. doi: 10.2196/74295.
- Individual participant dataSharing planned: No. No plan to share individual participant data (IPD)
Related trials for Forensic Nursing
Active, not recruiting
Forensic Nursing Education for Pediatric Nurses
Forensic Nursing Education in Pediatric Nurses, Forensic Competency Training
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.
Sara Wallström, PhD principal investigator
Västra Götalandsregionen
Questions about this trial
What is this clinical trial studying?
An observational study of Forensic Nursing and Forensic Psychiatry, run by Vastra Gotaland Region.
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 9 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: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Wallström, PhD (0701-714468, sara.wallstrom@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Safety Questionnaire (E13) (time frame: Change measure (baseline to 6 months)). The study lists 2 primary outcomes in all. 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 NCT05932108, 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 11 Jul 2023.