Nurse's RoleNCT05853588
The Effect Of Training On Nursing Qualıty
A study testing training in people with Nurse's Role, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study, in a randomized controlled design with pretest, posttest and control groups, is to determine the effect of on-the-job (toolbox) training given to nurses on nursing-sensitive quality indicators (pain management, pressure sores, patient falls, Peripheral Venous Catheter complications and adverse… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nurse's Role
- What is being tested?
- training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 30 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Working in one of the hospital's internal medicine or surgical services
- Being working in the current service for at least 6 months apart from past work experience
- Having completed the orientation process to the hospital and taking responsibility for patient care
- To voluntarily agree to participate in the study
Who cannot join
- Participants who did not meet the inclusion criteria were excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Univercity-Cerrahpaşa
Istanbul, Antakya
About this study
Official title: The Effect Of Toolbox Trainings On Nursing Sensitive Quality Indıcators
The aim of this study, in a randomized controlled design with pretest, posttest and control groups, is to determine the effect of on-the-job (toolbox) training given to nurses on nursing-sensitive quality indicators (pain management, pressure sores, patient falls, Peripheral Venous Catheter complications and adverse event reporting). it aims to answer are:
- Does toolbox training have an effect on nursing-sensitive quality indicators? After the training, participants are expected to adapt to quality practices.
Read more
This study consists of experimental and control groups. Experimental and control groups were determined by drawing lots with the help of an external expert. Nurses who met the inclusion criteria were included in the lottery.
Inclusion criteria for the experimental and control groups were determined as follows:
- Working in one of the hospital's internal medicine or surgical services
- Having been working in the current service for at least 6 months, apart from past work experience
- Having completed the orientation process to the hospital and taking responsibility for patient care
- Voluntarily agree to participate in the study
Read the detailed description
This study was carried out to determine the effect of toolbox training on nursing-sensitive quality indicators (pain management, pressure sores, patient falls, peripheral venous catheter complications and adverse event reporting) in a randomized controlled, pre-test, post-test, experimental and control group design.
The population of the study consisted of nurses working in the inpatient services (except the intensive care units) of a training and research hospital in Hatay. A total of 77 nurses working in the experimental and control group services determined by randomization constituted the sample of the research (experimental group: 38 nurses, control group: 39 nurses).
- Conditions
- Nurse's Role
- Being tested
- training
- Keywords
- quality indicators, quality in health, quality in nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trainingOther
On-the-job (toolbox) training given to the experimental group and containing brief information, lasting at most 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | It was determined by lot by the volunteer nurses who accepted to participate in the study. Receives: Other: training |
| Control group | No intervention | It was determined by lot by the volunteer nurses who accepted to participate in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nurse Information Form
This form consists of 10 questions in total to determine the demographic study characteristics of the nurses participating in the research.
Measured: before the training
Nursing Sensitive Quality Indicators Application Information Form (pretest-posttest)
Both groups were applied before the on-the-job training to be given to the experimental group and after all trainings were completed. It was prepared in the light of current literature in order to determine the knowledge level of nurses in the experimental and control groups about nursing-sensitive quality indicators and to evaluate the effectiveness of on-the-job training given to the experimental group. A minimum of 0 and a maximum of 100 points can be obtained from this test.
Measured: before the training
Nursing Sensitive Quality Indicators Implementation Checklists
The checklists developed in line with the literature have been developed for the management of pain in the unit, pressure ulcer, risk of falling, Peripheral Venous Catheter complications and adverse event reporting, and consist of five sections.In this test, 1 point is given for each complete application.
Measured: before the training
Unit Quality Indicators Monitoring Form
Data on 5 nursing-sensitive quality indicators (fall rates (in percent), patient rate with correct pain management (as a number), pressure ulcer rates (in percent), Peripheral Venous Catheter complication (as a number) and adverse event reporting rates(in percent) ) followed before and after the training, and data on the average number of hospitalization days are included.
Measured: before the training
Secondary outcomes (3)
Nursing Sensitive Quality Indicators Application Information Form (pretest-posttest)
Both groups were applied before the on-the-job training to be given to the experimental group and after all trainings were completed. It was prepared in the light of current literature in order to determine the knowledge level of nurses in the experimental and control groups about nursing-sensitive quality indicators and to evaluate the effectiveness of on-the-job training given to the experimental group. A minimum of 0 and a maximum of 100 points can be obtained from this test.
Measured: At 8 weeks after give all trainings
Nursing Sensitive Quality Indicators Implementation Checklists
The checklists developed in line with the literature have been developed for the management of pain in the unit, pressure ulcer, risk of falling, Peripheral Venous Catheter complications and adverse event reporting, and consist of five sections.In this test, 1 point is given for each complete application.
Measured: At 8 weeks after give all trainings
Unit Quality Indicators Monitoring Form
Data on 5 nursing-sensitive quality indicators (fall rates (in percent), patient rate with correct pain management (as a number), pressure ulcer rates (in percent), Peripheral Venous Catheter complication (as a number) and adverse event reporting rates(in percent) ) followed before and after the training, and data on the average number of hospitalization days are included.
Measured: At 8 weeks after give all trainings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Nov 2021
- Primary completion30 Jul 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study in randomized controlled, pretest, posttest and experiment, control group design
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bircan Kara, Istanbul University - Cerrahpasa
- Investigators
- Betül SÖNMEZ, Ass. prof, Study director, betul.sonmez@iuc.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853588
- Sponsor's protocol ID
- IstanbulUCerrahpaşabkara
- Status last verified
- May 2023
- First submitted
- 12 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heslop L, Lu S, Xu X. Nursing-sensitive indicators: a concept analysis. J Adv Nurs. 2014 Nov;70(11):2469-82. doi: 10.1111/jan.12503. Epub 2014 Aug 12.
PubMed 25113388Driscoll A, Grant MJ, Carroll D, Dalton S, Deaton C, Jones I, Lehwaldt D, McKee G, Munyombwe T, Astin F. The effect of nurse-to-patient ratios on nurse-sensitive patient outcomes in acute specialist units: a systematic review and meta-analysis. Eur J Cardiovasc Nurs. 2018 Jan;17(1):6-22. doi: 10.1177/1474515117721561. Epub 2017 Jul 18.
PubMed 28718658Donabedian A. The quality of care. How can it be assessed? JAMA. 1988 Sep 23-30;260(12):1743-8. doi: 10.1001/jama.260.12.1743.
PubMed 3045356Cavazza, N. & Serpe, A. 2010, The Impact of Safety Training Programs on Workers' Psychosocial Orientation and Behaviour. Revue internationale de psychologie sociale, 23, 187-210.
Amiri M, Khademian Z, Nikandish R. The effect of nurse empowerment educational program on patient safety culture: a randomized controlled trial. BMC Med Educ. 2018 Jul 3;18(1):158. doi: 10.1186/s12909-018-1255-6.
PubMed 29970054Burke MJ, Sarpy SA, Smith-Crowe K, Chan-Serafin S, Salvador RO, Islam G. Relative effectiveness of worker safety and health training methods. Am J Public Health. 2006 Feb;96(2):315-24. doi: 10.2105/AJPH.2004.059840. Epub 2005 Dec 27.
PubMed 16380566Kara B, Sonmez B. The Effect of Toolbox Trainings on Nursing Sensitive Quality Indicators: A Randomized Controlled Trial. J Nurs Scholarsh. 2025 May;57(3):439-451. doi: 10.1111/jnu.13051. Epub 2025 Jan 31.
PubMed 39888187
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Toolbox Trainings On Nursing Sensitive Quality Indıcators
- ClinicalTrials.gov ID
- NCT05853588
- Acronym / sponsor ID
- IstanbulUCerrahpaşabkara
- Conditions
- Nurse's Role
- Keywords
- quality indicators, quality in health, quality in nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 11 May 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 study, in a randomized controlled design with pretest, posttest and control groups, is to determine the effect of on-the-job (toolbox) training given to nurses on nursing-sensitive quality indicators (pain management, pressure sores, patient falls, Peripheral Venous Catheter complications and adverse event reporting). it aims to answer are:
- Does toolbox training have an effect on nursing-sensitive quality indicators? After the training, participants are expected to adapt to quality practices.
This study consists of experimental and control groups. Experimental and control groups were determined by drawing lots with the help of an external expert. Nurses who met the inclusion criteria were included in the lottery.
Inclusion criteria for the experimental and control groups were determined as follows:
- Working in one of the hospital's internal medicine or surgical services
- Having been working in the current service for at least 6 months, apart from past work experience
- Having completed the orientation process to the hospital and taking responsibility for patient care
- Voluntarily agree to participate in the study
Detailed description
This study was carried out to determine the effect of toolbox training on nursing-sensitive quality indicators (pain management, pressure sores, patient falls, peripheral venous catheter complications and adverse event reporting) in a randomized controlled, pre-test, post-test, experimental and control group design.
The population of the study consisted of nurses working in the inpatient services (except the intensive care units) of a training and research hospital in Hatay. A total of 77 nurses working in the experimental and control group services determined by randomization constituted the sample of the research (experimental group: 38 nurses, control group: 39 nurses).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study in randomized controlled, pretest, posttest and experiment, control group design
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: trainingIt was determined by lot by the volunteer nurses who accepted to participate in the study. |
| Control group | No intervention | –It was determined by lot by the volunteer nurses who accepted to participate in the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Working in one of the hospital's internal medicine or surgical services
- Being working in the current service for at least 6 months apart from past work experience
- Having completed the orientation process to the hospital and taking responsibility for patient care
- To voluntarily agree to participate in the study
Key exclusion criteria (1 listed)
- Participants who did not meet the inclusion criteria were excluded.
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 |
|---|---|---|
| trainingOn-the-job (toolbox) training given to the experimental group and containing brief information, lasting at most 10 minutes | Other | Experimental group |
Primary outcome
Nurse Information Form
Time frame: before the training
This form consists of 10 questions in total to determine the demographic study characteristics of the nurses participating in the research.
Nursing Sensitive Quality Indicators Application Information Form (pretest-posttest)
Time frame: before the training
Both groups were applied before the on-the-job training to be given to the experimental group and after all trainings were completed. It was prepared in the light of current literature in order to determine the knowledge level of nurses in the experimental and control groups about nursing-sensitive quality indicators and to evaluate the effectiveness of on-the-job training given to the experimental group. A minimum of 0 and a maximum of 100 points can be obtained from this test.
Nursing Sensitive Quality Indicators Implementation Checklists
Time frame: before the training
The checklists developed in line with the literature have been developed for the management of pain in the unit, pressure ulcer, risk of falling, Peripheral Venous Catheter complications and adverse event reporting, and consist of five sections.In this test, 1 point is given for each complete application.
Unit Quality Indicators Monitoring Form
Time frame: before the training
Data on 5 nursing-sensitive quality indicators (fall rates (in percent), patient rate with correct pain management (as a number), pressure ulcer rates (in percent), Peripheral Venous Catheter complication (as a number) and adverse event reporting rates(in percent) ) followed before and after the training, and data on the average number of hospitalization days are included.
3 secondary outcomes
Nursing Sensitive Quality Indicators Application Information Form (pretest-posttest)
Time frame: At 8 weeks after give all trainings
Nursing Sensitive Quality Indicators Implementation Checklists
Time frame: At 8 weeks after give all trainings
Unit Quality Indicators Monitoring Form
Time frame: At 8 weeks after give all trainings
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 11 May 2023.
- Results publication: PubMed 25113388Heslop L, Lu S, Xu X. Nursing-sensitive indicators: a concept analysis. J Adv Nurs. 2014 Nov;70(11):2469-82. doi: 10.1111/jan.12503. Epub 2014 Aug 12.
- Results publication: PubMed 28718658Driscoll A, Grant MJ, Carroll D, Dalton S, Deaton C, Jones I, Lehwaldt D, McKee G, Munyombwe T, Astin F. The effect of nurse-to-patient ratios on nurse-sensitive patient outcomes in acute specialist units: a systematic review and meta-analysis. Eur J Cardiovasc Nurs. 2018 Jan;17(1):6-22. doi: 10.1177/1474515117721561. Epub 2017 Jul 18.
- Results publication: PubMed 3045356Donabedian A. The quality of care. How can it be assessed? JAMA. 1988 Sep 23-30;260(12):1743-8. doi: 10.1001/jama.260.12.1743.
- Results publicationCavazza, N. & Serpe, A. 2010, The Impact of Safety Training Programs on Workers' Psychosocial Orientation and Behaviour. Revue internationale de psychologie sociale, 23, 187-210.
- Results publication: PubMed 29970054Amiri M, Khademian Z, Nikandish R. The effect of nurse empowerment educational program on patient safety culture: a randomized controlled trial. BMC Med Educ. 2018 Jul 3;18(1):158. doi: 10.1186/s12909-018-1255-6.
- Results publication: PubMed 16380566Burke MJ, Sarpy SA, Smith-Crowe K, Chan-Serafin S, Salvador RO, Islam G. Relative effectiveness of worker safety and health training methods. Am J Public Health. 2006 Feb;96(2):315-24. doi: 10.2105/AJPH.2004.059840. Epub 2005 Dec 27.
- Derived from this study: PubMed 39888187Kara B, Sonmez B. The Effect of Toolbox Trainings on Nursing Sensitive Quality Indicators: A Randomized Controlled Trial. J Nurs Scholarsh. 2025 May;57(3):439-451. doi: 10.1111/jnu.13051. Epub 2025 Jan 31.
- Individual participant dataSharing planned: No
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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.
Betül SÖNMEZ, Ass. prof study director
betul.sonmez@iuc.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training in people with Nurse's Role, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. 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 Turkey (Türkiye). 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?
Nurse Information Form (time frame: before the training). The study lists 4 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 NCT05853588, which also lists 7 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 11 May 2023.