Fixation Device; ComplicationsNCT06506799
Effect of Training on the Use of Physical Restraints
A study testing Training Given to Intensive Care Nurses on the Use of Physical Fixation in people with Fixation Device; Complications and Nursing Caries, run by Fenerbahce University.
Trial summary
Patients in the intensive care unit may harm themselves by pulling medical equipment such as endotracheal tube, monitoring, arterial and peripheral catheters. Physical detection is also one of the common practices used in this case. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fixation Device; Complications, Nursing Caries
- What is being tested?
- Training Given to Intensive Care Nurses on the Use of Physical Fixation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2024to 25 Oct 2024
- 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
- Working as a nurse in an adult intensive care unit
- Fill out the form completely
- Volunteering to participate in the study
- No vision or language problems to fill out the form
Who cannot join
- Filling the form incompletely
- Coming to the intensive care unit on rotation
- Not attending training
- No vision or language problems to fill out the form
- Having previously received training on physical detection
About this study
Official title: "Determining the Effect of the Training Given to Intensive Care Nurses on Their Knowledge Level, Attitudes and Practices Regarding the Use of Physical Restraints"
Patients in the intensive care unit may harm themselves by pulling medical equipment such as endotracheal tube, monitoring, arterial and peripheral catheters. Physical detection is also one of the common practices used in this case. Physical restraint is a practice performed by using patient aids to protect the individual or other patients around him, to ensure his safety and to control his behavior. Although physical detection seems to be a useful and simple method, it brings with it various physical, psychological, ethical, legal and moral problems. Nurses should use alternative strategies to prevent and reduce the use of restraint, and to avoid the negative consequences that may be caused by restraint by performing restraint appropriately and effectively, and thus ensure the safety of the patient. Evaluating nurses' knowledge on this subject, identifying deficiencies and providing training is important in terms of improving the quality of care and ensuring patient safety.
- Conditions
- Fixation Device; Complications, Nursing Caries
- Being tested
- Training Given to Intensive Care Nurses on the Use of Physical Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training Given to Intensive Care Nurses on the Use of Physical FixationOther
Data will be collected with the 'Participant Information Form' and the 'Nurses' Knowledge Level, Attitudes and Practices Regarding Physical Restraint Scale', prepared by the researcher in line with the literature and containing the demographic characteristics of the participants.
Intensive care nurses who will participate in the research will be asked to fill out the survey forms with individual consent.
Participant Information Form and Nurses' Knowledge, Attitude and Practice Levels Regarding Physical Restraint Scale will be used as pre-tests. After the pre-test, nurses will be given physical restraint training. The training content was created using the ADDIE model as reference. After the training, the Nurses' Knowledge Level, Attitudes and Practices Regarding Physical Restraint Scale will be used as the final test.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Other | Data will be collected with the 'Participant Information Form' and the 'Nurses' Knowledge Level, Attitudes and Practices Regarding Physical Restraint Scale', prepared by the researcher in line with the literature and containing the demographic characteristics of the participants.
Intensive care nurses who will participate in the research will be asked to fill out the survey forms with individual consent.
Participant Information Form and Nurses' Knowledge, Attitude and Practice Levels Regarding Physical Restraint Scale will be used as pre-tests. After the pre-test, nurses will be given physical restraint training. The training content was created using the ADDIE model as reference. After the training, the Nurses' Knowledge Level, Attitudes and Practices Regarding Physical Restraint Scale will be used as the final test. Receives: Other: Training Given to Intensive Care Nurses on the Use of Physical Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome 1
Training on the Use of Physical Restraint Given to Intensive Care Nurses Will Increase the Score of the Nurses' Knowledge Level, Attitudes and Practices Regarding Physical Restraint Scale.
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start28 Aug 2024 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion25 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fixation Device; ComplicationsStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ogr. Uyesi Naile, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506799
- Sponsor's protocol ID
- 66.2024fbu
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Determining the Effect of the Training Given to Intensive Care Nurses on Their Knowledge Level, Attitudes and Practices Regarding the Use of Physical Restraints"
- ClinicalTrials.gov ID
- NCT06506799
- Acronym / sponsor ID
- 66.2024fbu
- Conditions
- Fixation Device; Complications, Nursing Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 28 Aug 2024 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 25 Oct 2024 (estimated)
- First posted
- 18 Jul 2024 (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.
Patients in the intensive care unit may harm themselves by pulling medical equipment such as endotracheal tube, monitoring, arterial and peripheral catheters. Physical detection is also one of the common practices used in this case. Physical restraint is a practice performed by using patient aids to protect the individual or other patients around him, to ensure his safety and to control his behavior. Although physical detection seems to be a useful and simple method, it brings with it various physical, psychological, ethical, legal and moral problems. Nurses should use alternative strategies to prevent and reduce the use of restraint, and to avoid the negative consequences that may be caused by restraint by performing restraint appropriately and effectively, and thus ensure the safety of the patient. Evaluating nurses' knowledge on this subject, identifying deficiencies and providing training is important in terms of improving the quality of care and ensuring patient safety.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Other | Other: Training Given to Intensive Care Nurses on the Use of Physical FixationData will be collected with the 'Participant Information Form' and the 'Nurses' Knowledge Level, Attitudes and Practices Regarding Physical Restraint Scale', prepared by the researcher in line with the literature and containing the demographic characteristics of the participants. Intensive care nurses who will participate in the research will be asked to fill out the survey forms with individual consent. Participant Information Form and Nurses' Knowledge, Attitude and Practice Levels Regarding Physical Restraint Scale will be used as pre-tests. After the pre-test, nurses will be given physical restraint training. The training content was created using the ADDIE model as reference. After the training, the Nurses' Knowledge Level, Attitudes and Practices Regarding Physical Restraint Scale will be used as the final test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Working as a nurse in an adult intensive care unit
- Fill out the form completely
- Volunteering to participate in the study
- No vision or language problems to fill out the form
Key exclusion criteria (5 listed)
- Filling the form incompletely
- Coming to the intensive care unit on rotation
- Not attending training
- No vision or language problems to fill out the form
- Having previously received training on physical detection
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 |
|---|---|---|
| Training Given to Intensive Care Nurses on the Use of Physical FixationData will be collected with the 'Participant Information Form' and the 'Nurses' Knowledge Level, Attitudes and Practices Regarding Physical Restraint Scale', prepared by the researcher in line with the literature and containing the demographic characteristics of the participants. Intensive care nurses who will participate in the research will be asked to fill out the survey forms with individual consent. Participant Information Form and Nurses' Knowledge, Attitude and Practice Levels Regarding Physical Restraint Scale will be used as pre-tests. After the pre-test, nurses will be given physical restraint training. The training content was created using the ADDIE model as reference. After the training, the Nurses' Knowledge Level, Attitudes and Practices Regarding Physical Restraint Scale will be used as the final test. | Other | intervention |
Primary outcome
outcome 1
Time frame: 2 week
Training on the Use of Physical Restraint Given to Intensive Care Nurses Will Increase the Score of the Nurses' Knowledge Level, Attitudes and Practices Regarding Physical Restraint Scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Fixation Device; Complications
Not yet recruiting
Reduction of Complications Associated With Extraluminal PICC Management.
Treatment (ProudMe), Vascular Access
Active, not recruitingObservational study
Results Of Usage Of Bridging Plate In Multi-fragmentary Distal Radius Fracture
Distal Radius Fractures, Mechanical Complication of Internal Rod Fixation Device
Not yet recruiting
Pelvic Osteotomy in Bladder Exstrophy
Bladder Exstrophy
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.
Questions about this trial
What is this clinical trial studying?
A study testing Training Given to Intensive Care Nurses on the Use of Physical Fixation in people with Fixation Device; Complications and Nursing Caries, run by Fenerbahce University.
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 4 inclusion and 5 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 18 Jul 2024. 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?
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?
outcome 1 (time frame: 2 week). 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 18 Jul 2024.