Clinical trial NCT05225987: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-Care Power Scale Score
timeFrame: 5 months
measure: Postpartum Quality of Life Scale Score
timeFrame: 5 months
measure: Postpartum Specific Anxiety Scale Score
timeFrame: 5 months
measure: Edinburgh Postpartum Depression Scale Score
timeFrame: 5 months
measure: Physical Symptom Severity Scale Score
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences Etlik Zübeyde Hanim Gyn Diseases Education and Research Hospital
Study officials:
affiliation: Hacettepe University
name: Gülten Koç
role: STUDY_DIRECTOR
References: