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Effects of Postpartum Nurse Navigation Program

Primary Purpose

Nursing Caries, Nurse's Role, Postpartum Depression

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Postpartum Nurse Navigation Program based care
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Nursing Caries focused on measuring Postpartum, Nurse Navigation Program, Quality of life, Self care power, Postpartum depression

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. between the ages of 18-45
  2. gestational week ≥36,
  3. primiparous and singleton pregnancy,
  4. no vision and hearing problems,
  5. able to communicate via telephone,
  6. no complications during pregnancy and delivery (preeclampsia; eclapsia; diabetes; 7. hypertension; heart disease; kidney failure; HIV /AIDS)

8. pregnant women will be included.

Exclusion Criteria:

  1. Mothers who were illiterate,
  2. had problems in communicating,
  3. did not have a mobile phone of their own,
  4. residing outside the province of Ankara,
  5. had mental disability and severe mental illness and
  6. had preterm or postterm birth will exclude from the study.

Sites / Locations

  • University of Health Sciences Etlik Zübeyde Hanim Gyn Diseases Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimantal Group

Control group

Arm Description

Postpartum Nurse Navigation Program based care

This group will take routin care

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).

Secondary Outcome Measures

Full Information

First Posted
June 11, 2021
Last Updated
February 7, 2022
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05225987
Brief Title
Effects of Postpartum Nurse Navigation Program
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 24, 2021 (Actual)
Study Completion Date
December 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimantal Group
Arm Type
Experimental
Arm Description
Postpartum Nurse Navigation Program based care
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group will take routin care
Intervention Type
Behavioral
Intervention Name(s)
Postpartum Nurse Navigation Program based care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-Care Power Scale Score
Description
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).
Time Frame
5 months
Title
Postpartum Quality of Life Scale Score
Description
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).
Time Frame
5 months
Title
Postpartum Specific Anxiety Scale Score
Description
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).
Time Frame
5 months
Title
Edinburgh Postpartum Depression Scale Score
Description
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).
Time Frame
5 months
Title
Physical Symptom Severity Scale Score
Description
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).
Time Frame
5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülten Koç
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
Facility Information:
Facility Name
University of Health Sciences Etlik Zübeyde Hanim Gyn Diseases Education and Research Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
There is a plan to make IPD and related data dictionaries available.
IPD Sharing Time Frame
march, 2022
IPD Sharing Access Criteria
When the study is converted into a protocol or an article, it will be published in an international journal by the researchers.

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Effects of Postpartum Nurse Navigation Program

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