Nursing CariesNCT05225987
Effects of Postpartum Nurse Navigation Program
A study testing Postpartum Nurse Navigation Program based care in people with Nursing Caries and Nurse's Role, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The study was planned as a two-group parallel randomized controlled experimental study in order to determine the effects of the nurse navigation program developed for mothers in the postpartum period on mothers' self-care power, quality of life, anxiety and depression risks, and physical symptom severity. 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
- Nursing Caries, Nurse's Role, Postpartum Depression
- What is being tested?
- Postpartum Nurse Navigation Program based care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 24 Dec 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- between the ages of 18-45
- gestational week ≥36,
- primiparous and singleton pregnancy,
- no vision and hearing problems,
- able to communicate via telephone,
- no complications during pregnancy and delivery (preeclampsia; eclapsia; diabetes; 7. hypertension; heart disease; kidney failure; HIV /AIDS)
- 8. pregnant women will be included.
Who cannot join
- Mothers who were illiterate,
- had problems in communicating,
- did not have a mobile phone of their own,
- residing outside the province of Ankara,
- had mental disability and severe mental illness and
- had preterm or postterm birth will exclude from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Etlik Zübeyde Hanim Gyn Diseases Education and Research Hospital
Ankara, 06010
About this study
Official title: The Effect of Nurse Navigation Program Developed for Postpartum Mothers on Mothers' Self-Care Power, Quality of Life, Anxiety and Depression Risks, and Physical Symptom Severity
The study was planned as a two-group parallel randomized controlled experimental study in order to determine the effects of the nurse navigation program developed for mothers in the postpartum period on mothers' self-care power, quality of life, anxiety and depression risks, and physical symptom severity. The study will be carried out in Ankara Etlik Zübeyde Hanım Gynecology Training and Research Hospital. The population of the research will be primiparous mothers who gave birth vaginally in Ankara.
Read the detailed description
Primiparous pregnant women who come to the pregnancy outpatient clinic, are at 36 weeks of gestation or more, meet the inclusion criteria and volunteer, will be informed about the program and will be included in the sample of the study. There will be two groups assigned by the stratified block randomization method in the study. The number of samples to be taken into the control and intervention groups was determined by power analysis and the sample size was planned to be 32 mothers for the intervention group and 32 mothers for the control group. In addition to routine hospital care, the intervention group will receive navigation program-based nursing care that includes three home visits, three phone calls, and sending text messages at five different times. The control group will not receive any intervention other than routine hospital care practices. The data of the research; "Data Collection Form on Descriptive Characteristics", "Postpartum Mother and Newborn Evaluation and Diagnosis Form", "Mother and Newborn Problems Evaluation Form in the Postpartum Period", "Mother and Baby Follow-up Evaluation Form in the Postpartum Period", "Self-Care Power" Scale', 'Postpartum Quality of Life Scale', 'Postpartum Specific Anxiety Scale', 'Edinburgh Postpartum Depression Scale' and 'Physical Symptom Severity Scale' will be collected using descriptive statistics (number, min., mean, standard deviation, standard deviation) in the evaluation of the data. max.) will be used. The conformity of the data to the normal distribution will be evaluated with the Shapiro Wilks test. The relationship between them in qualitative variables will be evaluated with the chi-square test and Fisher's exact test. The Cochran Q test will be used to examine change over time. In numerical variables, according to the normal distribution; In independent groups, t test, Mann Whitney U test, one-way analysis of variance (ANOVA), Kruskal Wallis Analysis will be used. Before and after repeated measurements, according to the normal distribution; In repeated measurements, one-way analysis of variance or Friedman test will be used. Significance will be evaluated at the p<0.05 level. The independent variables of the research will be stated as numbers and percentages.
- Conditions
- Nursing Caries, Nurse's Role, Postpartum Depression, Postpartum Anxiety, Quality of Life, Postpartum Disorder
- Being tested
- Postpartum Nurse Navigation Program based care
- Keywords
- Postpartum, Nurse Navigation Program, Quality of life, Self care power, Postpartum depression
- Medical subject headings
- Depression, Postpartum, Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum Nurse Navigation Program based careBehavioural
In addition to routine hospital care, the intervention group will receive navigation program-based nursing care that includes three home visits, three phone calls, and sending text messages at five different times.
| Study group | Role | What they receive |
|---|---|---|
| Experimantal Group | Experimental | Postpartum Nurse Navigation Program based care Receives: Behavioral: Postpartum Nurse Navigation Program based care |
| Control group | No intervention | This group will take routin care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Care Power Scale Score
The Self-Care Power Scale was developed by Kearney and Fleischer (1979) to determine individuals' ability to take care of themselves. Its Turkish validity and reliability was determined by Nahçıvan (1993), and the Cronbach α coefficient of the scale was stated as 0.89 (Nahcivan, 2004).
The Scale consists of 35 items. Each item of this 5-point Likert-type scale, according to the answer given; It is evaluated by giving 0 points for the answer "Doesn't describe me at all", and 4 points for the answer "It describes me a lot". Evaluation is made out of a total of 140 points. Below 82 points is considered as low, 82-120 points as medium, above 120 points as high (Nahcivan, 2004).
Measured: 5 months
Postpartum Quality of Life Scale Score
It was developed by Hill et al (2006) to evaluate the postpartum quality of life of mothers. The Turkish validity and reliability study of the scale was carried out by Altuntuğ and Ege (2012), and the internal consistency coefficient of the scale was determined as 0.95 in the study (Altuntuğ \& Ege, 2012).
In the first part of the scale, satisfaction with each item is questioned, and in the second part, the importance is questioned. All items are evaluated on a 6-point Likert scale. Satisfaction and Significance sections of the scale are numbered from 1 to 6. 1=Not at all Satisfied, 2=Moderately Dissatisfied, 3=Slightly Dissatisfied, 4=Slightly Satisfied, 5=Moderately Satisfied, 6=Very Satisfied. The Quality of Life Score is in the range of 0-30. The higher the score obtained from the scale, the higher the person's postpartum quality of life, and lower scores the lower the postpartum quality of life (Hill et al. 2006, Altuntuğ \& Ege, 2012).
Measured: 5 months
Postpartum Specific Anxiety Scale Score
Fallon et al. (2016) to evaluate postpartum anxiety symptoms (Fallon et al, 2016). The Turkish validity and reliability study of the scale was conducted by Duran (2019), and the internal consistency coefficient of the scale was determined as 0.91 in the study (Duran, 2019).
The scale consists of 51 items. It has been stated that those who score 73 and below on the scale have low postpartum anxiety levels, those who score between 74 and 100 have a medium level, and those who score 101 and above have a high level (Duran, 2019). The scale was administered within 6 months of postpartum and it was recommended to be used during this period. In the development of the scale, retests were performed 2 weeks after the scale was applied (Fallon et al, 2016).
Measured: 5 months
Edinburgh Postpartum Depression Scale Score
It was developed by Cox (1987). The scale is a self-report scale aimed at screening postpartum depression in women (Cox et al, 1987). The Turkish validity and reliability study of the scale was carried out by Engindeniz et al. (1996), and they found the internal consistency coefficient of the scale as 0.79 (Engindeniz et al., 1996). In this study, the Cronbach α value of the scale will be calculated.
EPDS consists of 10 items. Each item of the scale is evaluated in a 4-point Likert format and the answer given to each item is scored between 0 and 3 (0, 1, 2, 3). The lowest score that can be obtained from the scale is 0, and the highest score is 30. In the evaluation of the scale, the 1st, 2nd and 4th items are scored as 0-1-2-3, while the 3rd, 5th, 6th, 7th, 8th, 9th and 10th items are scored as 3-2-1-0. are scored inversely. The cut-off point of the scale is 12. Women with a score of 12 and above are considered to be at risk for depression (Engindeniz, 1996).
Measured: 5 months
Physical Symptom Severity Scale Score
The scale was developed by Cine et al (2009) and aims to determine the prevalence and persistence of postpartum physical symptoms (Chien et al, 2009). The Turkish validity and reliability study of the scale was carried out by Arkan (2016). In the study of Arkan (2016), the internal consistency of the scale was determined to be at a very reliable level (Cronbach α=0.79). In this study, the cronbach α value of the scale will be calculated.
The scale consists of 18 items. Each item of the scale is in a 4-point Likert format and these items are evaluated as 0 (absent), 1 (mild), 2 (moderate), and 3 (high). Scale total score ranges from 0 to 54. High scores obtained from the scale indicate that the severity of postpartum physical symptoms is high (Arkan, 2016).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Jun 2021
- Primary completion24 Dec 2021
- Study completion24 Dec 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 Nursing CariesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pinar Uzunkaya Oztoprak, Hacettepe University
- Investigators
- Gülten Koç, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225987
- Sponsor's protocol ID
- 2020/12
- Status last verified
- Feb 2022
- First submitted
- 11 Jun 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Publications
Oztoprak PU, Koc G, Erkaya S. Evaluation of the effect of a nurse navigation program developed for postpartum mothers on maternal health: A randomized controlled study. Public Health Nurs. 2023 Sep-Oct;40(5):672-684. doi: 10.1111/phn.13226. Epub 2023 Jul 13.
PubMed 37443414
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse Navigation Program Developed for Postpartum Mothers on Mothers' Self-Care Power, Quality of Life, Anxiety and Depression Risks, and Physical Symptom Severity
- ClinicalTrials.gov ID
- NCT05225987
- Acronym / sponsor ID
- 2020/12
- Conditions
- Nursing Caries, Nurse's Role, Postpartum Depression, Postpartum Anxiety, Quality of Life, Postpartum Disorder
- Keywords
- Postpartum, Nurse Navigation Program, Quality of life, Self care power, Postpartum depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 7 Feb 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.
The study was planned as a two-group parallel randomized controlled experimental study in order to determine the effects of the nurse navigation program developed for mothers in the postpartum period on mothers' self-care power, quality of life, anxiety and depression risks, and physical symptom severity. The study will be carried out in Ankara Etlik Zübeyde Hanım Gynecology Training and Research Hospital. The population of the research will be primiparous mothers who gave birth vaginally in Ankara.
Detailed description
Primiparous pregnant women who come to the pregnancy outpatient clinic, are at 36 weeks of gestation or more, meet the inclusion criteria and volunteer, will be informed about the program and will be included in the sample of the study. There will be two groups assigned by the stratified block randomization method in the study. The number of samples to be taken into the control and intervention groups was determined by power analysis and the sample size was planned to be 32 mothers for the intervention group and 32 mothers for the control group. In addition to routine hospital care, the intervention group will receive navigation program-based nursing care that includes three home visits, three phone calls, and sending text messages at five different times. The control group will not receive any intervention other than routine hospital care practices. The data of the research; "Data Collection Form on Descriptive Characteristics", "Postpartum Mother and Newborn Evaluation and Diagnosis Form", "Mother and Newborn Problems Evaluation Form in the Postpartum Period", "Mother and Baby Follow-up Evaluation Form in the Postpartum Period", "Self-Care Power" Scale', 'Postpartum Quality of Life Scale', 'Postpartum Specific Anxiety Scale', 'Edinburgh Postpartum Depression Scale' and 'Physical Symptom Severity Scale' will be collected using descriptive statistics (number, min., mean, standard deviation, standard deviation) in the evaluation of the data. max.) will be used. The conformity of the data to the normal distribution will be evaluated with the Shapiro Wilks test. The relationship between them in qualitative variables will be evaluated with the chi-square test and Fisher's exact test. The Cochran Q test will be used to examine change over time. In numerical variables, according to the normal distribution; In independent groups, t test, Mann Whitney U test, one-way analysis of variance (ANOVA), Kruskal Wallis Analysis will be used. Before and after repeated measurements, according to the normal distribution; In repeated measurements, one-way analysis of variance or Friedman test will be used. Significance will be evaluated at the p<0.05 level. The independent variables of the research will be stated as numbers and percentages.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimantal Group | Experimental | Behavioral: Postpartum Nurse Navigation Program based carePostpartum Nurse Navigation Program based care |
| Control group | No intervention | –This group will take routin care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- between the ages of 18-45
- gestational week ≥36,
- primiparous and singleton pregnancy,
- no vision and hearing problems,
- able to communicate via telephone,
Key exclusion criteria (6 listed)
- Mothers who were illiterate,
- had problems in communicating,
- did not have a mobile phone of their own,
- residing outside the province of Ankara,
- had mental disability and severe mental illness and
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 |
|---|---|---|
| Postpartum Nurse Navigation Program based careIn addition to routine hospital care, the intervention group will receive navigation program-based nursing care that includes three home visits, three phone calls, and sending text messages at five different times. | Behavioural | Experimantal Group |
Primary outcome
Self-Care Power Scale Score
Time frame: 5 months
The Self-Care Power Scale was developed by Kearney and Fleischer (1979) to determine individuals' ability to take care of themselves. Its Turkish validity and reliability was determined by Nahçıvan (1993), and the Cronbach α coefficient of the scale was stated as 0.89 (Nahcivan, 2004). The Scale consists of 35 items. Each item of this 5-point Likert-type scale, according to the answer given; It is evaluated by giving 0 points for the answer "Doesn't describe me at all", and 4 points for the answer "It describes me a lot". Evaluation is made out of a total of 140 points. Below 82 points is considered as low, 82-120 points as medium, above 120 points as high (Nahcivan, 2004).
Postpartum Quality of Life Scale Score
Time frame: 5 months
It was developed by Hill et al (2006) to evaluate the postpartum quality of life of mothers. The Turkish validity and reliability study of the scale was carried out by Altuntuğ and Ege (2012), and the internal consistency coefficient of the scale was determined as 0.95 in the study (Altuntuğ \& Ege, 2012). In the first part of the scale, satisfaction with each item is questioned, and in the second part, the importance is questioned. All items are evaluated on a 6-point Likert scale. Satisfaction and Significance sections of the scale are numbered from 1 to 6. 1=Not at all Satisfied, 2=Moderately Dissatisfied, 3=Slightly Dissatisfied, 4=Slightly Satisfied, 5=Moderately Satisfied, 6=Very Satisfied. The Quality of Life Score is in the range of 0-30. The higher the score obtained from the scale, the higher the person's postpartum quality of life, and lower scores the lower the postpartum quality of life (Hill et al. 2006, Altuntuğ \& Ege, 2012).
Postpartum Specific Anxiety Scale Score
Time frame: 5 months
Fallon et al. (2016) to evaluate postpartum anxiety symptoms (Fallon et al, 2016). The Turkish validity and reliability study of the scale was conducted by Duran (2019), and the internal consistency coefficient of the scale was determined as 0.91 in the study (Duran, 2019). The scale consists of 51 items. It has been stated that those who score 73 and below on the scale have low postpartum anxiety levels, those who score between 74 and 100 have a medium level, and those who score 101 and above have a high level (Duran, 2019). The scale was administered within 6 months of postpartum and it was recommended to be used during this period. In the development of the scale, retests were performed 2 weeks after the scale was applied (Fallon et al, 2016).
Edinburgh Postpartum Depression Scale Score
Time frame: 5 months
It was developed by Cox (1987). The scale is a self-report scale aimed at screening postpartum depression in women (Cox et al, 1987). The Turkish validity and reliability study of the scale was carried out by Engindeniz et al. (1996), and they found the internal consistency coefficient of the scale as 0.79 (Engindeniz et al., 1996). In this study, the Cronbach α value of the scale will be calculated. EPDS consists of 10 items. Each item of the scale is evaluated in a 4-point Likert format and the answer given to each item is scored between 0 and 3 (0, 1, 2, 3). The lowest score that can be obtained from the scale is 0, and the highest score is 30. In the evaluation of the scale, the 1st, 2nd and 4th items are scored as 0-1-2-3, while the 3rd, 5th, 6th, 7th, 8th, 9th and 10th items are scored as 3-2-1-0. are scored inversely. The cut-off point of the scale is 12. Women with a score of 12 and above are considered to be at risk for depression (Engindeniz, 1996).
Physical Symptom Severity Scale Score
Time frame: 5 months
The scale was developed by Cine et al (2009) and aims to determine the prevalence and persistence of postpartum physical symptoms (Chien et al, 2009). The Turkish validity and reliability study of the scale was carried out by Arkan (2016). In the study of Arkan (2016), the internal consistency of the scale was determined to be at a very reliable level (Cronbach α=0.79). In this study, the cronbach α value of the scale will be calculated. The scale consists of 18 items. Each item of the scale is in a 4-point Likert format and these items are evaluated as 0 (absent), 1 (mild), 2 (moderate), and 3 (high). Scale total score ranges from 0 to 54. High scores obtained from the scale indicate that the severity of postpartum physical symptoms is high (Arkan, 2016).
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 23 Feb 2022.
- Derived from this study: PubMed 37443414Oztoprak PU, Koc G, Erkaya S. Evaluation of the effect of a nurse navigation program developed for postpartum mothers on maternal health: A randomized controlled study. Public Health Nurs. 2023 Sep-Oct;40(5):672-684. doi: 10.1111/phn.13226. Epub 2023 Jul 13.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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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.
Gülten Koç 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 Postpartum Nurse Navigation Program based care in people with Nursing Caries and Nurse's Role, 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 7 inclusion and 6 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 23 Feb 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?
Self-Care Power Scale Score (time frame: 5 months). The study lists 5 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 NCT05225987, 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 23 Feb 2022; AzTrials last refreshed its copy on 28 Oct 2026.