Life QualityNCT06290700
Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life
A study testing Neonatal Care education in people with Life Quality and Functional Status, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effect of neonatal care education for primiparous pregnant women on postpartum maternal function and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Life Quality, Functional Status
- What is being tested?
- Neonatal Care education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Feb 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being at least a primary school graduate.
- Being a primiparous pregnant woman.
- Being able to provide feedback.
Who cannot join
- Being a multiparous pregnant woman.
- Being a high-risk pregnant woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life: Randomised Controlled Trial
This study aimed to evaluate the effect of neonatal care education for primiparous pregnant women on postpartum maternal function and quality of life.
Read the detailed description
This was a single blind randomised controlled experimental study. The sample size of the study was calculated using the G*Power 3.1.7 program, considering a 5% margin of error and 95% confidence interval, and was determined to be at least 61. Therefore, the sample was planned to consist of 122 pregnant women, including 61 pregnant women in the intervention group and 61 pregnant women in the control group.
Study Inclusion Criteria Being at least a primary school graduate. Being a primiparous pregnant woman. Being able to provide feedback. Study Exclusion Criteria Being a multiparous pregnant woman. Being a high-risk pregnant woman. Participants who met the study inclusion criteria were provided with information about the purpose and conduct of the study, and their consent to participate was then obtained. The interviews were conducted in the breastfeeding room at the Uşak Dikilitaş Family Health Centre. The data were collected between November 2022 and November 2023. The Family Health Centre has two vaccination rooms, two antenatal care rooms, two observation rooms, and two breastfeeding rooms. Each pregnant woman was individually enrolled in an education session held in the breastfeeding room. The breastfeeding room was approximately 20 m², which was considered standard for accommodating training for an average of three pregnant women. The breastfeeding room was quiet, had a suitable temperature, and was located on the first floor in the middle of the corridor.
- Conditions
- Life Quality, Functional Status
- Being tested
- Neonatal Care education
- Keywords
- functional status, life quality, mothers, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal Care educationBehavioural
Participants who met the study inclusion criteria were provided with information about the purpose and conduct of the study, and their consent to participate was then obtained. The interviews were conducted in the breastfeeding room at the Uşak Dikilitaş Family Health Centre. The data were collected between November 2022 and November 2023. The Family Health Centre has two vaccination rooms, two antenatal care rooms, two observation rooms, and two breastfeeding rooms. Each pregnant woman was individually enrolled in an education session held in the breastfeeding room. The breastfeeding room was approximately 20 m², which was considered standard for accommodating training for an average of three pregnant women. The breastfeeding room was quiet, had a suitable temperature, and was located on the first floor in the middle of the corridor.
| Study group | Role | What they receive |
|---|---|---|
| İntervational group | Experimental | Neonatal care education given to primiparous pregnant women affect their postpartum maternal function Neonatal care education given to primiparous pregnant women affect their postpartum quality of life? Receives: Behavioral: Neonatal Care education |
| Control group | No intervention | All pregnant women, those in the control group, were provide with standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of maternal function by Barkin Index of Maternal Functioning
The scale was used 6 weeks after childbirth
Measured: 10 weeks after after the intervention
Secondary outcomes (1)
Maternal Postpartum Quality of Life Instrument
The scale was used 6 weeks after childbirth
Measured: 10 weeks after 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 posted4 Mar 2024
- Study start1 Nov 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Life QualityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290700
- Sponsor's protocol ID
- MCBU_2880
- Status last verified
- Feb 2024
- First submitted
- 26 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neonatal Care Education for Primiparous Pregnant Women on Postpartum Maternal Function and Quality of Life: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06290700
- Acronym / sponsor ID
- MCBU_2880
- Conditions
- Life Quality, Functional Status
- Keywords
- functional status, life quality, mothers, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 4 Mar 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 evaluate the effect of neonatal care education for primiparous pregnant women on postpartum maternal function and quality of life.
Detailed description
This was a single blind randomised controlled experimental study. The sample size of the study was calculated using the G*Power 3.1.7 program, considering a 5% margin of error and 95% confidence interval, and was determined to be at least 61. Therefore, the sample was planned to consist of 122 pregnant women, including 61 pregnant women in the intervention group and 61 pregnant women in the control group.
Study Inclusion Criteria Being at least a primary school graduate. Being a primiparous pregnant woman. Being able to provide feedback. Study Exclusion Criteria Being a multiparous pregnant woman. Being a high-risk pregnant woman. Participants who met the study inclusion criteria were provided with information about the purpose and conduct of the study, and their consent to participate was then obtained. The interviews were conducted in the breastfeeding room at the Uşak Dikilitaş Family Health Centre. The data were collected between November 2022 and November 2023. The Family Health Centre has two vaccination rooms, two antenatal care rooms, two observation rooms, and two breastfeeding rooms. Each pregnant woman was individually enrolled in an education session held in the breastfeeding room. The breastfeeding room was approximately 20 m², which was considered standard for accommodating training for an average of three pregnant women. The breastfeeding room was quiet, had a suitable temperature, and was located on the first floor in the middle of the corridor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İntervational group | Experimental | Behavioral: Neonatal Care educationNeonatal care education given to primiparous pregnant women affect their postpartum maternal function Neonatal care education given to primiparous pregnant women affect their postpartum quality of life? |
| Control group | No intervention | –All pregnant women, those in the control group, were provide with standard |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being at least a primary school graduate.
- Being a primiparous pregnant woman.
- Being able to provide feedback.
Key exclusion criteria (2 listed)
- Being a multiparous pregnant woman.
- Being a high-risk pregnant woman.
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 |
|---|---|---|
| Neonatal Care educationParticipants who met the study inclusion criteria were provided with information about the purpose and conduct of the study, and their consent to participate was then obtained. The interviews were conducted in the breastfeeding room at the Uşak Dikilitaş Family Health Centre. The data were collected between November 2022 and November 2023. The Family Health Centre has two vaccination rooms, two antenatal care rooms, two observation rooms, and two breastfeeding rooms. Each pregnant woman was individually enrolled in an education session held in the breastfeeding room. The breastfeeding room was approximately 20 m², which was considered standard for accommodating training for an average of three pregnant women. The breastfeeding room was quiet, had a suitable temperature, and was located on the first floor in the middle of the corridor. | Behavioural | İntervational group |
Primary outcome
severity of maternal function by Barkin Index of Maternal Functioning
Time frame: 10 weeks after after the intervention
The scale was used 6 weeks after childbirth
1 secondary outcome
Maternal Postpartum Quality of Life Instrument
Time frame: 10 weeks after after the intervention
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 4 Mar 2024.
Related trials for Life Quality
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neonatal Care education in people with Life Quality and Functional Status, run by Manisa Celal Bayar 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 3 inclusion and 2 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 4 Mar 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?
severity of maternal function by Barkin Index of Maternal Functioning (time frame: 10 weeks after after the intervention). 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 4 Mar 2024.