TrainingNCT06268028
Discharge Training Given to Primiparous Mothers Who Had a Cesarean Delivery
A study testing Training in people with Training, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of discharge training given to primiparous mothers who gave birth by cesarean section on the level of readiness for discharge. The research is a pre-test-post-test, randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Training
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2024to 30 Apr 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to speak and understand Turkish,
- At least primary school graduate,
- 18 years and over,
- Those who gave birth by cesarean section,
- Primiparous mothers will be included in the research.
Who cannot join
- Those who have a physical disability (vision, hearing, etc.) that prevents them from taking care of themselves,
- In a risky postpartum period,
- Having a history of chronic disease,
- Those who were hospitalized during pregnancy,
- Those who do not have their baby with them after birth,
- Foreign nationals,
- Mothers with psychiatric diagnoses will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Maternity and Child Health Hospital
Aydin, 09010
About this study
Official title: The Effect on the Level of Readiness for Discharge of Discharge Training Given to Primiparous Mothers Having a Cesarean Delivery : A Randomized Controlled Study
This study aimed to determine the effect of discharge training given to primiparous mothers who gave birth by cesarean section on the level of readiness for discharge.
The research is a pre-test-post-test, randomized controlled experimental study.
Read the detailed description
The research is a pre-test-post-test, randomized controlled experimental study. To prevent selection bias, participants were included in the training and control groups by applying the randomization method. The sample consisted of a total of 70 women (experimental group: 35 women and control group: 35 women). The study was carried out with women who lying to Obstetrics Clinic of Aydın Gynecology and Children's Diseases Hospital and met the study criteria.
- Conditions
- Training
- Being tested
- Training
- Keywords
- Training of discharge, Caesarean section, Primiparous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Discharge training
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENT GROUP | Experimental | The individual identification form was first filled out using the face-to-face interview technique. An explanation given regarding filling out the scale and they will be asked to fill it out by self-reporting method under observation. When the mothers in the training group feel good and ready; discharge training gave using the discharge training brochure prepared by the researchers by reviewing the literature. We provided discharge training in the mother's own room and in an average of 30-45 minutes with a one-on-one training method. Mothers asked to fill out the "RHD-NMF" themselves again, close to postnatal discharge. Receives: Behavioral: Training |
| CONTROL GROUP | No intervention | Starting from the first (smallest number) room in the clinic, the individual identification form was filled out initially by face-to-face interview technique for mothers who meet the appropriate conditions and agree to participate in the study, according to the randomization order. An explanation given regarding filling out the scale and they will be asked to fill it out by self-reporting method under observation. Mothers asked to fill out the "RHD-NMF" themselves again, close to postnatal discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A pre-test applied to 70 women who constitute the sample of the research.
In the pre-test; The individual introduction form and scale used, and the same scale used for the post-test. Individual Introduction Form: Sociodemographic (Age, educational status, health insurance, etc.) and obstetric characteristics (number of pregnancies, number of miscarriages/abortions etc). (15 questions) (RHD-NMF): Scale that evaluates readiness for hospital discharge according to the mother's perception; It consists of four subscales and a total of 23 items. The lowest score that can be obtained from the scale is '0' and the highest score is '220'.
Measured: 16 weeks
Secondary outcomes (1)
Apost-test applied to 70 women who constitute the sample of the research.
When the mothers in the training group feel good and ready; discharge training was provided using the discharge training brochure prepared by the researchers by reviewing the literature. Discharge training gave one-on-one in the mother's own room, lasting approximately 30-45 minutes. Lectures and question-answer methods used as training techniques. Close to postpartum discharge, mothers in both groups asked to fill out the "RHD-NMF" (post-test) themselves again.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start10 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrainingStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belma Toptas Acar, Aydin Adnan Menderes University
- Investigators
- BELMA TOPTAŞ ACAR, Res.assist, Principal investigator, Res.assist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268028
- Sponsor's protocol ID
- BELMA TA
- Status last verified
- Aug 2024
- First submitted
- 13 Feb 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: OUR STUDY WAS SUPPORTED BY TUBITAK-2209-A UNIVERSITY STUDENTS RESEARCH PROJECTS SUPPORT PROGRAM. OUR DATA COLLECTION PROCESS FİNİSHED.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on the Level of Readiness for Discharge of Discharge Training Given to Primiparous Mothers Having a Cesarean Delivery : A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06268028
- Acronym / sponsor ID
- BELMA TA
- Conditions
- Training
- Keywords
- Training of discharge, Caesarean section, Primiparous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 20 Feb 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.
This study aimed to determine the effect of discharge training given to primiparous mothers who gave birth by cesarean section on the level of readiness for discharge.
The research is a pre-test-post-test, randomized controlled experimental study.
Detailed description
The research is a pre-test-post-test, randomized controlled experimental study. To prevent selection bias, participants were included in the training and control groups by applying the randomization method. The sample consisted of a total of 70 women (experimental group: 35 women and control group: 35 women). The study was carried out with women who lying to Obstetrics Clinic of Aydın Gynecology and Children's Diseases Hospital and met the study criteria.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENT GROUP | Experimental | Behavioral: TrainingThe individual identification form was first filled out using the face-to-face interview technique. An explanation given regarding filling out the scale and they will be asked to fill it out by self-reporting method under observation. When the mothers in the training group feel good and ready; discharge training gave using the discharge training brochure prepared by the researchers by reviewing the literature. We provided discharge training in the mother's own room and in an average of 30-45 minutes with a one-on-one training method. Mothers asked to fill out the "RHD-NMF" themselves again, close to postnatal discharge. |
| CONTROL GROUP | No intervention | –Starting from the first (smallest number) room in the clinic, the individual identification form was filled out initially by face-to-face interview technique for mothers who meet the appropriate conditions and agree to participate in the study, according to the randomization order. An explanation given regarding filling out the scale and they will be asked to fill it out by self-reporting method under observation. Mothers asked to fill out the "RHD-NMF" themselves again, close to postnatal discharge. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able to speak and understand Turkish,
- At least primary school graduate,
- 18 years and over,
- Those who gave birth by cesarean section,
- Primiparous mothers will be included in the research.
Key exclusion criteria (7 listed)
- Those who have a physical disability (vision, hearing, etc.) that prevents them from taking care of themselves,
- In a risky postpartum period,
- Having a history of chronic disease,
- Those who were hospitalized during pregnancy,
- Those who do not have their baby with them after birth,
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 |
|---|---|---|
| TrainingDischarge training | Behavioural | EXPERIMENT GROUP |
Primary outcome
A pre-test applied to 70 women who constitute the sample of the research.
Time frame: 16 weeks
In the pre-test; The individual introduction form and scale used, and the same scale used for the post-test. Individual Introduction Form: Sociodemographic (Age, educational status, health insurance, etc.) and obstetric characteristics (number of pregnancies, number of miscarriages/abortions etc). (15 questions) (RHD-NMF): Scale that evaluates readiness for hospital discharge according to the mother's perception; It consists of four subscales and a total of 23 items. The lowest score that can be obtained from the scale is '0' and the highest score is '220'.
1 secondary outcome
Apost-test applied to 70 women who constitute the sample of the research.
Time frame: 16 weeks
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 6 Aug 2024.
- Individual participant dataSharing planned: Yes. OUR STUDY WAS SUPPORTED BY TUBITAK-2209-A UNIVERSITY STUDENTS RESEARCH PROJECTS SUPPORT PROGRAM. OUR DATA COLLECTION PROCESS FİNİSHED.
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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.
BELMA TOPTAŞ ACAR, Res.assist principal investigator
Res.assist
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 Training, run by Aydin Adnan Menderes 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 7 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 6 Aug 2024. 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?
A pre-test applied to 70 women who constitute the sample of the research. (time frame: 16 weeks). 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 6 Aug 2024.