Effects of Postpartum Nurse Navigation Program

NCT ID: NCT05225987

Last Updated: 2022-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-12-24

Brief Summary

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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

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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

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Nursing Caries Nurse's Role Postpartum Depression Postpartum Anxiety Quality of Life Postpartum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimantal Group

Postpartum Nurse Navigation Program based care

Group Type EXPERIMENTAL

Postpartum Nurse Navigation Program based care

Intervention Type 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.

Control group

This group will take routin care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Postpartum Nurse Navigation Program based care

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Pinar Uzunkaya Oztoprak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülten Koç

Role: STUDY_DIRECTOR

Hacettepe University

Locations

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

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 37443414 (View on PubMed)

Other Identifiers

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2020/12

Identifier Type: -

Identifier Source: org_study_id

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