Effects of Postpartum Nurse Navigation Program

NCT05225987 | Completed

• 1 other identifier: 2020/12
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• 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).

  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).

  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).

  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).

  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).

  5 months

Study Arms (2)

Experimantal Group

EXPERIMENTAL

Postpartum Nurse Navigation Program based care

Behavioral: Postpartum Nurse Navigation Program based care

Control group

NO INTERVENTION

This group will take routin care

Interventions

Postpartum Nurse Navigation Program based care BEHAVIORAL

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.

Experimantal Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• \. pregnant women will be included.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

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

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 37443414 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Puerperal Disorders

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Gülten Koç

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: February 7, 2022
• Study Start: June 1, 2021
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: march, 2022
• Access Criteria: When the study is converted into a protocol or an article, it will be published in an international journal by the researchers.

Locations

TU (1)