CounselingViolenceNCT05582486
The Effectiveness of The Training Program Given to Midwives and Nurses to Prevent Obstetric Violence
A study testing obstetric violence prevention education intervention in people with Counseling, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
In the study, 84 midwives and nurses working in hospital delivery and puerperal services and family health centers in Adiyaman province constituted the experimental group, and the control group of 84 midwives and nurses working in the delivery room and postpartum services of hospital Child and Gynecology Hospital in… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Counseling
- What is being tested?
- obstetric violence prevention education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 30 Sep 2021
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over,
- Those who do not have any problems during pregnancy, birth and postpartum period (such as heart disease, preeclampsia, diabetes, difficult birth, fetal anomaly),
- No psychological health problems according to medical records,
- Those who are open to communication and cooperation.
Who cannot join
- Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Education Program for Preventing Obstetric Violence to mi̇dwi̇fe and Nurses:Results of Ebe, Nurses and Women Taking Care
In the study, 84 midwives and nurses working in hospital delivery and puerperal services and family health centers in Adiyaman province constituted the experimental group, and the control group of 84 midwives and nurses working in the delivery room and postpartum services of hospital Child and Gynecology Hospital in Malatya and family health centers', determined by randomization in the study. While the training program for the prevention of obstetric violence consisting of 16 sessions was applied by the researcher to the midwives and nurses in the experimental group, no intervention was applied to the midwives and nurses in the control group. The second phase of the study was conducted with women who received care from the hospital delivery and postpartum services and family health centers in Adiyaman province before and after the training program applied to the midwives and nurses in the experimental group (158 women before the training, 158 after the training). Data were collected with Introductory Information Forms, Caring Behaviors Inventory-30, Communication Skills Scale and Care Satisfaction Evaluation Form.
Read the detailed description
The research was conducted between November 2020 and December 2021. In the study, 84 midwives and nurses working in hospital delivery and puerperal services and family health centers in Adiyaman province constituted the experimental group, and the control group of 84 midwives and nurses working in the delivery room and postpartum services of hospital Child and Gynecology Hospital in Malatya and family health centers', determined by randomization in the study. While the training program for the prevention of obstetric violence consisting of 16 sessions was applied by the researcher to the midwives and nurses in the experimental group, no intervention was applied to the midwives and nurses in the control group. The second phase of the study was conducted with women who received care from the hospital delivery and postpartum services and family health centers in Adiyaman province before and after the training program applied to the midwives and nurses in the experimental group (158 women before the training, 158 after the training). Data were collected with Introductory Information Forms, Caring Behaviors Inventory-30, Communication Skills Scale and Care Satisfaction Evaluation Form.
- Conditions
- Counseling
- Being tested
- obstetric violence prevention education intervention
- Keywords
- obstetric violence, communication, care, midwife, nurse
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obstetric violence prevention education interventionBehavioural
While the training program for the prevention of obstetric violence consisting of 16 sessions was applied by the researcher to the midwives and nurses in the experimental group, no intervention was applied to the midwives and nurses in the control group.
| Study group | Role | What they receive |
|---|---|---|
| obstetric violence prevention education intervention | Experimental | The training program for the prevention of obstetric violence was given to the midwives and nurses in the experimental group by the researcher in the form of group training in the training hall of the relevant institution. The trainings were completed in a total of 16 sessions, two sessions a day and four sessions a week. Sessions were held between 16:00 and 18:00 on weekdays, each lasting approximately 40-45 minutes, with a 10-minute break between sessions. Thus, the training program applied to the experimental group was completed in 4 weeks.
The main purpose of the training program is to prevent obstetric violence perpetrated by midwives and nurses. The training content created for this purpose included the definition of obstetric violence, pregnant and fetus rights, factors causing obstetric violence and strategies to be used to reduce obstetric violence.
Other Names:
• group-ED Receives: Behavioral: obstetric violence prevention education intervention |
| Standard of care | Experimental | Midwives and nurses in this group did not perform any practice.
. group- SB Receives: Behavioral: obstetric violence prevention education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caring Behaviors Scale-30
Caring Behaviors Inventory-30: Wolf et al. In 1994, he evaluated patient care from a philosophical and ethical point of view (136). The scale consists of 30 items and consists of three sub-dimensions: respect for others, professional knowledge and attitude, and accessibility by the individual. The 6 Likert-type scales have options never (1), rarely (2), sometimes (3), usually (4), almost always (5), and always (6). The minimum score that can be obtained from the total of the scale is 30, and the maximum score is 180. The minimum score that can be obtained from each sub-dimension of the scale is 10, and the maximum score is 60. As the sub-dimension and total scale score increase, the care perception of patients and/or caregivers increases positively.
Measured: through study completion, an average of 1 year
Communication Skills Scale
It was developed by Korkut in order to understand how individuals evaluate their communication skills. The scale, which is a five-point Likert type, consists of 25 statements. The scale has options never (0), rarely (1), sometimes (2), often (3), and always (4). The minimum score that can be obtained from the scale is 0, and the maximum score is 100. As the scores obtained from the scale increase, it means that individuals evaluate their communication skills positively. The Cronbach's alpha reliability coefficient of the scale was found to be 0.80. In this study, α=0.94 of the scale was found.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Apr 2021
- Primary completion25 Aug 2021
- Study completion30 Sep 2021
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 CounselingStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nurten özçalkap, Inonu University
- Investigators
- Nurten ÖZÇALKAP, Msc, Principal investigator, Adiyaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582486
- Sponsor's protocol ID
- 2020-1235
- Acronym
- Violence
- Status last verified
- Oct 2022
- First submitted
- 19 May 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be obtained either from study investigators.
Publications
Mannava P, Durrant K, Fisher J, Chersich M, Luchters S. Attitudes and behaviours of maternal health care providers in interactions with clients: a systematic review. Global Health. 2015 Aug 15;11:36. doi: 10.1186/s12992-015-0117-9.
PubMed 26276053
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Education Program for Preventing Obstetric Violence to mi̇dwi̇fe and Nurses:Results of Ebe, Nurses and Women Taking Care
- ClinicalTrials.gov ID
- NCT05582486
- Acronym / sponsor ID
- Violence / 2020-1235
- Conditions
- Counseling
- Keywords
- obstetric violence, communication, care, midwife, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 17 Oct 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.
In the study, 84 midwives and nurses working in hospital delivery and puerperal services and family health centers in Adiyaman province constituted the experimental group, and the control group of 84 midwives and nurses working in the delivery room and postpartum services of hospital Child and Gynecology Hospital in Malatya and family health centers', determined by randomization in the study. While the training program for the prevention of obstetric violence consisting of 16 sessions was applied by the researcher to the midwives and nurses in the experimental group, no intervention was applied to the midwives and nurses in the control group. The second phase of the study was conducted with women who received care from the hospital delivery and postpartum services and family health centers in Adiyaman province before and after the training program applied to the midwives and nurses in the experimental group (158 women before the training, 158 after the training). Data were collected with Introductory Information Forms, Caring Behaviors Inventory-30, Communication Skills Scale and Care Satisfaction Evaluation Form.
Detailed description
The research was conducted between November 2020 and December 2021. In the study, 84 midwives and nurses working in hospital delivery and puerperal services and family health centers in Adiyaman province constituted the experimental group, and the control group of 84 midwives and nurses working in the delivery room and postpartum services of hospital Child and Gynecology Hospital in Malatya and family health centers', determined by randomization in the study. While the training program for the prevention of obstetric violence consisting of 16 sessions was applied by the researcher to the midwives and nurses in the experimental group, no intervention was applied to the midwives and nurses in the control group. The second phase of the study was conducted with women who received care from the hospital delivery and postpartum services and family health centers in Adiyaman province before and after the training program applied to the midwives and nurses in the experimental group (158 women before the training, 158 after the training). Data were collected with Introductory Information Forms, Caring Behaviors Inventory-30, Communication Skills Scale and Care Satisfaction Evaluation Form.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obstetric violence prevention education intervention | Experimental | Behavioral: obstetric violence prevention education interventionThe training program for the prevention of obstetric violence was given to the midwives and nurses in the experimental group by the researcher in the form of group training in the training hall of the relevant institution. The trainings were completed in a total of 16 sessions, two sessions a day and four sessions a week. Sessions were held between 16:00 and 18:00 on weekdays, each lasting approximately 40-45 minutes, with a 10-minute break between sessions. Thus, the training program applied to the experimental group was completed in 4 weeks. The main purpose of the training program is to prevent obstetric violence perpetrated by midwives and nurses. The training content created for this purpose included the definition of obstetric violence, pregnant and fetus rights, factors causing obstetric violence and strategies to be used to reduce obstetric violence. Other Names: • group-ED |
| Standard of care | Experimental | Behavioral: obstetric violence prevention education interventionMidwives and nurses in this group did not perform any practice. . group- SB |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and over,
- Those who do not have any problems during pregnancy, birth and postpartum period (such as heart disease, preeclampsia, diabetes, difficult birth, fetal anomaly),
- No psychological health problems according to medical records,
- Those who are open to communication and cooperation.
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria
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 |
|---|---|---|
| obstetric violence prevention education interventionWhile the training program for the prevention of obstetric violence consisting of 16 sessions was applied by the researcher to the midwives and nurses in the experimental group, no intervention was applied to the midwives and nurses in the control group. | Behavioural | Standard of care, obstetric violence prevention education intervention |
Primary outcome
Caring Behaviors Scale-30
Time frame: through study completion, an average of 1 year
Caring Behaviors Inventory-30: Wolf et al. In 1994, he evaluated patient care from a philosophical and ethical point of view (136). The scale consists of 30 items and consists of three sub-dimensions: respect for others, professional knowledge and attitude, and accessibility by the individual. The 6 Likert-type scales have options never (1), rarely (2), sometimes (3), usually (4), almost always (5), and always (6). The minimum score that can be obtained from the total of the scale is 30, and the maximum score is 180. The minimum score that can be obtained from each sub-dimension of the scale is 10, and the maximum score is 60. As the sub-dimension and total scale score increase, the care perception of patients and/or caregivers increases positively.
Communication Skills Scale
Time frame: through study completion, an average of 1 year
It was developed by Korkut in order to understand how individuals evaluate their communication skills. The scale, which is a five-point Likert type, consists of 25 statements. The scale has options never (0), rarely (1), sometimes (2), often (3), and always (4). The minimum score that can be obtained from the scale is 0, and the maximum score is 100. As the scores obtained from the scale increase, it means that individuals evaluate their communication skills positively. The Cronbach's alpha reliability coefficient of the scale was found to be 0.80. In this study, α=0.94 of the scale was found.
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 17 Oct 2022.
- Background: PubMed 26276053Mannava P, Durrant K, Fisher J, Chersich M, Luchters S. Attitudes and behaviours of maternal health care providers in interactions with clients: a systematic review. Global Health. 2015 Aug 15;11:36. doi: 10.1186/s12992-015-0117-9.
- Manuscript full textLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data may be obtained either from study investigators.
Related trials for Counseling
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
Recruiting
Climate-Responsive Nutrition, WASH, and Heat Counselling for Maternal and Child Health in Sindh, Pakistan
Maternal Nutrition, Child Nutrition
Not yet recruiting
Using Virtual Reality to Augment Brief Interventions for Heavy Drinking Young Adults
Alcohol Misuse
Not yet recruiting
New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial
Smoking Cessation, Smoking Cessation Counselling
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.
Nurten ÖZÇALKAP, Msc principal investigator
Adiyaman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing obstetric violence prevention education intervention in people with Counseling, run by Inonu 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 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 17 Oct 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?
Caring Behaviors Scale-30 (time frame: through study completion, an average of 1 year). 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 NCT05582486, 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 17 Oct 2022.