Communication, MultidisciplinaryNCT05187598
The Effect of Communication Training on the Communication Skills of the Students
A study testing Effective communication training in perinatal patient safety in people with Communication, Multidisciplinary, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Patient safety, which is an important concept in terms of providing effective and high-quality health care, is defined as "preventing health care errors and eliminating or reducing patient damage caused by health care errors". Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Communication, Multidisciplinary
- What is being tested?
- Effective communication training in perinatal patient safety
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2021to 1 Sep 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- To have taken the course of Obstetrics-Gynecology Nursing,
- To be able to understand, and speak Turkish at a good level,
- Being able to use a computer,
- Having personal internet access.
- To be a volunteer.
Who cannot join
- Not participating in any stage of the research,
- Having a disability (physical/visual/auditory) that may prevent computer and internet use,
- Wanting to leave the at any stage of the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Online Communication Training Focused on Maintaining Perinatal Patient Safety for Nursing Students
Patient safety, which is an important concept in terms of providing effective and high-quality health care, is defined as "preventing health care errors and eliminating or reducing patient damage caused by health care errors". Worldwide, adverse events from unsafe care are estimated to be one of the 10 leading causes of death and disability. Ineffective communication between healthcare professionals, which is among the factors that cause errors related to patient safety, is reported as one of the factors that have the most impact on medical errors and unintentional patient harm. Studies show that ineffective communication between healthcare professionals may be responsible for up to 80% of all preventable adverse events rather than the patient's medical condition. Considering the number of lawsuits and cost increase due to errors that violate patient safety, it is stated that medical errors are higher especially in the field of perinatology. In studies conducted, errors in the communication process were identified as the main cause in 72% of all perinatal deaths. The perinatal period is a physiological process. However, undesirable events can develop suddenly and rapidly, and this situation threatens both pregnant/mother and fetus/newborn health. Therefore, it is necessary to maintain uninterrupted communication in this area. It is very important for students to acquire these communication skills effectively before they graduate. Therefore, this research; In order to determine the effect of professional communication training among health professionals to be given to nursing students on the professional communication skills of students, a parallel-group was planned as a randomized controlled trial. The study is planned to be conducted in Hacettepe University Nursing Faculty. Research data will be collected using the Student Introductory Information Form, Effective Communication Skills Among Healthcare Professionals Evaluation Form, Self-Assessment Form for Effective Communication among Healthcare Professionals, and Semi-Structured Focus Group Interview Form. Nursing students who meet the inclusion criteria will be included in the research. Students will be divided into 2 groups as the experimental and the control group. Students in the experimental group will be given training on effective communication among health professionals. No training will be given to the control group.
- Conditions
- Communication, Multidisciplinary
- Being tested
- Effective communication training in perinatal patient safety
- Keywords
- nursing students, communication, patient safety, standard participant
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effective communication training in perinatal patient safetyOther
Students will be given theoretical training, group discussion will be made over sample videos, and students will participate in the standard participant practice and a post-analysis session will be held.
| Study group | Role | What they receive |
|---|---|---|
| Effective communication training in perinatal patient safety | Experimental | Nursing department students will be given training on effective communication training in perinatal patient safety. Receives: Other: Effective communication training in perinatal patient safety |
| Control group | No intervention | There is no intervention for this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective communication form among perinatal healthcare professionals
It is the evaluation of the professional communication of nursing students with a nurse and a physician working in the perinatal area through an effective communication form.
Measured: 1 week before the intervention to 1 week after the intervention.
Self-assessments of effective communication skills form among perinatal healthcare professionals
It is the self-evaluation of nursing students for their professional communication with a nurse and a physician working in the perinatal area through an effective communication self-assessment form.
Measured: 1 week before the intervention to 1 week after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start27 Nov 2021
- Primary completion5 Dec 2021
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Communication, MultidisciplinaryStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel group randomized controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Cigdem Yucel Ozcırpan, Sergul Duygulu
- Responsible party
- Principal investigator, SEVDA YILDIRIM HAMURCU, Hacettepe University
- Investigators
- Sergul Duygulu, PhD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187598
- Sponsor's protocol ID
- GO 19/74
- Status last verified
- Sep 2022
- First submitted
- 20 Dec 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD
Publications
Janakiraman V, Ecker J. Quality in obstetric care: measuring what matters. Obstet Gynecol. 2010 Sep;116(3):728-732. doi: 10.1097/AOG.0b013e3181ea4d4f.
PubMed 20733459Deering S, Johnston LC, Colacchio K. Multidisciplinary teamwork and communication training. Semin Perinatol. 2011 Apr;35(2):89-96. doi: 10.1053/j.semperi.2011.01.009.
PubMed 21440817Hailu FB, Kassahun CW, Kerie MW. Perceived Nurse-Physician Communication in Patient Care and Associated Factors in Public Hospitals of Jimma Zone, South West Ethiopia: Cross Sectional Study. PLoS One. 2016 Sep 15;11(9):e0162264. doi: 10.1371/journal.pone.0162264. eCollection 2016.
PubMed 27632162Hogan H, Zipfel R, Neuburger J, Hutchings A, Darzi A, Black N. Avoidability of hospital deaths and association with hospital-wide mortality ratios: retrospective case record review and regression analysis. BMJ. 2015 Jul 14;351:h3239. doi: 10.1136/bmj.h3239.
PubMed 26174149James JT. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf. 2013 Sep;9(3):122-8. doi: 10.1097/PTS.0b013e3182948a69.
PubMed 23860193Jha AK, Prasopa-Plaizier N, Larizgoitia I, Bates DW; Research Priority Setting Working Group of the WHO World Alliance for Patient Safety. Patient safety research: an overview of the global evidence. Qual Saf Health Care. 2010 Feb;19(1):42-7. doi: 10.1136/qshc.2008.029165.
PubMed 20172882Karkowsky CE, Chazotte C. Simulation: improving communication with patients. Semin Perinatol. 2013 Jun;37(3):157-60. doi: 10.1053/j.semperi.2013.02.006.
PubMed 23721771Leonard M, Graham S, Bonacum D. The human factor: the critical importance of effective teamwork and communication in providing safe care. Qual Saf Health Care. 2004 Oct;13 Suppl 1(Suppl 1):i85-90. doi: 10.1136/qhc.13.suppl_1.i85.
PubMed 15465961Lippke S, Derksen C, Keller FM, Kotting L, Schmiedhofer M, Welp A. Effectiveness of Communication Interventions in Obstetrics-A Systematic Review. Int J Environ Res Public Health. 2021 Mar 5;18(5):2616. doi: 10.3390/ijerph18052616.
PubMed 33807819Lyndon A. Communication and teamwork in patient care: how much can we learn from aviation? J Obstet Gynecol Neonatal Nurs. 2006 Jul-Aug;35(4):538-46. doi: 10.1111/j.1552-6909.2006.00074.x.
PubMed 16882000Makary MA, Daniel M. Medical error-the third leading cause of death in the US. BMJ. 2016 May 3;353:i2139. doi: 10.1136/bmj.i2139. No abstract available.
PubMed 27143499Martinez-Galiano JM, Martinez-Vazquez S, Rodriguez-Almagro J, Hernandez-Martinez A. The magnitude of the problem of obstetric violence and its associated factors: A cross-sectional study. Women Birth. 2021 Sep;34(5):e526-e536. doi: 10.1016/j.wombi.2020.10.002. Epub 2020 Oct 17.
PubMed 33082123Muller M, Jurgens J, Redaelli M, Klingberg K, Hautz WE, Stock S. Impact of the communication and patient hand-off tool SBAR on patient safety: a systematic review. BMJ Open. 2018 Aug 23;8(8):e022202. doi: 10.1136/bmjopen-2018-022202.
PubMed 30139905Pettker CM, Thung SF, Lipkind HS, Illuzzi JL, Buhimschi CS, Raab CA, Copel JA, Lockwood CJ, Funai EF. A comprehensive obstetric patient safety program reduces liability claims and payments. Am J Obstet Gynecol. 2014 Oct;211(4):319-25. doi: 10.1016/j.ajog.2014.04.038. Epub 2014 Jun 9.
PubMed 24925798Reising DL, Carr DE, Gindling S, Barnes R, Garletts D, Ozdogan Z. Team Communication Influence on Procedure Performance: Findings From Interprofessional Simulations with Nursing and Medical Students. Nurs Educ Perspect. 2017 Sep/Oct;38(5):275-276. doi: 10.1097/01.NEP.0000000000000168.
PubMed 28562460
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Online Communication Training Focused on Maintaining Perinatal Patient Safety for Nursing Students
- ClinicalTrials.gov ID
- NCT05187598
- Acronym / sponsor ID
- GO 19/74
- Conditions
- Communication, Multidisciplinary
- Keywords
- nursing students, communication, patient safety, standard participant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Cigdem Yucel Ozcırpan, Sergul Duygulu
- Study start
- 27 Nov 2021 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 12 Jan 2022 (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.
Patient safety, which is an important concept in terms of providing effective and high-quality health care, is defined as "preventing health care errors and eliminating or reducing patient damage caused by health care errors". Worldwide, adverse events from unsafe care are estimated to be one of the 10 leading causes of death and disability. Ineffective communication between healthcare professionals, which is among the factors that cause errors related to patient safety, is reported as one of the factors that have the most impact on medical errors and unintentional patient harm. Studies show that ineffective communication between healthcare professionals may be responsible for up to 80% of all preventable adverse events rather than the patient's medical condition. Considering the number of lawsuits and cost increase due to errors that violate patient safety, it is stated that medical errors are higher especially in the field of perinatology. In studies conducted, errors in the communication process were identified as the main cause in 72% of all perinatal deaths. The perinatal period is a physiological process. However, undesirable events can develop suddenly and rapidly, and this situation threatens both pregnant/mother and fetus/newborn health. Therefore, it is necessary to maintain uninterrupted communication in this area. It is very important for students to acquire these communication skills effectively before they graduate. Therefore, this research; In order to determine the effect of professional communication training among health professionals to be given to nursing students on the professional communication skills of students, a parallel-group was planned as a randomized controlled trial. The study is planned to be conducted in Hacettepe University Nursing Faculty. Research data will be collected using the Student Introductory Information Form, Effective Communication Skills Among Healthcare Professionals Evaluation Form, Self-Assessment Form for Effective Communication among Healthcare Professionals, and Semi-Structured Focus Group Interview Form. Nursing students who meet the inclusion criteria will be included in the research. Students will be divided into 2 groups as the experimental and the control group. Students in the experimental group will be given training on effective communication among health professionals. No training will be given to the control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel group randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Effective communication training in perinatal patient safety | Experimental | Other: Effective communication training in perinatal patient safetyNursing department students will be given training on effective communication training in perinatal patient safety. |
| Control group | No intervention | –There is no intervention for this group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- To have taken the course of Obstetrics-Gynecology Nursing,
- To be able to understand, and speak Turkish at a good level,
- Being able to use a computer,
- Having personal internet access.
- To be a volunteer.
Key exclusion criteria (3 listed)
- Not participating in any stage of the research,
- Having a disability (physical/visual/auditory) that may prevent computer and internet use,
- Wanting to leave the at any stage of the research.
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 |
|---|---|---|
| Effective communication training in perinatal patient safetyStudents will be given theoretical training, group discussion will be made over sample videos, and students will participate in the standard participant practice and a post-analysis session will be held. | Other | Effective communication training in perinatal patient safety |
Primary outcome
Effective communication form among perinatal healthcare professionals
Time frame: 1 week before the intervention to 1 week after the intervention.
It is the evaluation of the professional communication of nursing students with a nurse and a physician working in the perinatal area through an effective communication form.
Self-assessments of effective communication skills form among perinatal healthcare professionals
Time frame: 1 week before the intervention to 1 week after the intervention.
It is the self-evaluation of nursing students for their professional communication with a nurse and a physician working in the perinatal area through an effective communication self-assessment form.
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 14 Sep 2022.
- Background: PubMed 20733459Janakiraman V, Ecker J. Quality in obstetric care: measuring what matters. Obstet Gynecol. 2010 Sep;116(3):728-732. doi: 10.1097/AOG.0b013e3181ea4d4f.
- Background: PubMed 21440817Deering S, Johnston LC, Colacchio K. Multidisciplinary teamwork and communication training. Semin Perinatol. 2011 Apr;35(2):89-96. doi: 10.1053/j.semperi.2011.01.009.
- Background: PubMed 27632162Hailu FB, Kassahun CW, Kerie MW. Perceived Nurse-Physician Communication in Patient Care and Associated Factors in Public Hospitals of Jimma Zone, South West Ethiopia: Cross Sectional Study. PLoS One. 2016 Sep 15;11(9):e0162264. doi: 10.1371/journal.pone.0162264. eCollection 2016.
- Background: PubMed 26174149Hogan H, Zipfel R, Neuburger J, Hutchings A, Darzi A, Black N. Avoidability of hospital deaths and association with hospital-wide mortality ratios: retrospective case record review and regression analysis. BMJ. 2015 Jul 14;351:h3239. doi: 10.1136/bmj.h3239.
- Background: PubMed 23860193James JT. A new, evidence-based estimate of patient harms associated with hospital care. J Patient Saf. 2013 Sep;9(3):122-8. doi: 10.1097/PTS.0b013e3182948a69.
- Background: PubMed 20172882Jha AK, Prasopa-Plaizier N, Larizgoitia I, Bates DW; Research Priority Setting Working Group of the WHO World Alliance for Patient Safety. Patient safety research: an overview of the global evidence. Qual Saf Health Care. 2010 Feb;19(1):42-7. doi: 10.1136/qshc.2008.029165.
- Background: PubMed 23721771Karkowsky CE, Chazotte C. Simulation: improving communication with patients. Semin Perinatol. 2013 Jun;37(3):157-60. doi: 10.1053/j.semperi.2013.02.006.
- Background: PubMed 15465961Leonard M, Graham S, Bonacum D. The human factor: the critical importance of effective teamwork and communication in providing safe care. Qual Saf Health Care. 2004 Oct;13 Suppl 1(Suppl 1):i85-90. doi: 10.1136/qhc.13.suppl_1.i85.
- Background: PubMed 33807819Lippke S, Derksen C, Keller FM, Kotting L, Schmiedhofer M, Welp A. Effectiveness of Communication Interventions in Obstetrics-A Systematic Review. Int J Environ Res Public Health. 2021 Mar 5;18(5):2616. doi: 10.3390/ijerph18052616.
- Background: PubMed 16882000Lyndon A. Communication and teamwork in patient care: how much can we learn from aviation? J Obstet Gynecol Neonatal Nurs. 2006 Jul-Aug;35(4):538-46. doi: 10.1111/j.1552-6909.2006.00074.x.
- Background: PubMed 27143499Makary MA, Daniel M. Medical error-the third leading cause of death in the US. BMJ. 2016 May 3;353:i2139. doi: 10.1136/bmj.i2139. No abstract available.
- Background: PubMed 33082123Martinez-Galiano JM, Martinez-Vazquez S, Rodriguez-Almagro J, Hernandez-Martinez A. The magnitude of the problem of obstetric violence and its associated factors: A cross-sectional study. Women Birth. 2021 Sep;34(5):e526-e536. doi: 10.1016/j.wombi.2020.10.002. Epub 2020 Oct 17.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD
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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.
Sergul Duygulu, PhD study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effective communication training in perinatal patient safety in people with Communication, Multidisciplinary, run by Hacettepe University 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 5 inclusion and 3 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 14 Sep 2022. 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?
Effective communication form among perinatal healthcare professionals (time frame: 1 week before the intervention to 1 week after the intervention.). 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 NCT05187598, which also lists 18 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 14 Sep 2022.