Clinical trial NCT06101186: The Effect of Nursing Counseling Perceived Stress, Coping and Birth Outcomes Among Pregnant Women
Official title: The Effect of Nursing Counseling Based on Neuman Systems Model on Perceived Stress, Coping With Stress and Birth Outcomes Among Pregnant Women at High Risk of Pre-term Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: Risk of Preterm Labor
Neuman Systems Model
Stress
Coping with Stress
Birth Outcomes
Lead sponsor: Erzurum Technical University
Sponsor class: OTHER
Collaborators: name: Ondokuz Mayıs University
First posted: 2023-10-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: The aim of this study is to determine the effect of the Pregnant Nursing Education and Counseling Program (HEGDAP), which is structured on the Neuman Systems Model, on the perception of stress, coping with stress and birth outcomes in pregnant women with preterm labor risk.

Method: This study was conducted with 60 pregnant women at risk of preterm labor, including 30 experimental and 30 control, non-randomized double-blind pregnant women using pretest, interim follow-up and posttest. Data were collected using a personal information form, Perceived Stress in Risky Pregnancies Questionnaire, Ways of Coping with Stress Scale and Birth Outcomes Evaluation Form. Nursing counseling based on Neuman's System Model was applied to the intervention group. Data were evaluated using analysis methods such as t-test, chi-square, etc.

Detailed description: Although pregnancy is a physiological condition involving homeostatic adaptations, it is also a process that can subject pregnant women to stress and vulnerability. Pregnant women experience stress due to various factors such as bodily changes, hormonal fluctuations, physical symptoms, concerns about parenting, relationship issues, fear of childbirth, and the health of their baby. Risky pregnant women, compared to non-risky pregnant women, experience even more intense stress related to their own health and the health of their babies. The stressors faced by risky pregnant women include being diagnosed with a risky pregnancy, experiencing an unwanted pregnancy, encountering signs of danger during pregnancy, negative thoughts related to the baby, hospitalization, fear of childbirth, adolescent pregnancies, marital problems, lack of social support, economic concerns, and postpartum problems. Perceived stress during pregnancy can lead to negative birth outcomes such as preterm labor, spontaneous abortion, neonatal malformation, low birth weight, and prenatal developmental delay. Pregnant women reporting high stress have a 25% to 60% increased risk of preterm birth compared to those reporting low stress. A study found that pregnant women perceiving high stress during pregnancy were twice as likely to experience premature labor and twelve times more likely to give birth to a low birth weight baby. Another study showed that stressed pregnant women give birth an average of one and a half weeks earlier than healthy pregnant women. Stress is considered a modifiable factor that contributes to preterm birth, and eliminating its negative effects can help reduce the rate of preterm birth due to maternal stress.To cope with the stress associated with a risky pregnancy, it is crucial for pregnant women to utilize coping mechanisms they have used in the past and learn new coping strategies. However, 27.4 percent of pregnant women in Turkey feel that their ability to cope with stress is inadequate. It is recommended that nurses provide training and counseling to help pregnant women at risk of preterm birth cope with stress more effectively. Encouraging participation in stress-reduction programs that provide specific information, education, or relaxation methods is important for pregnant women at risk, and counseling should be provided toward the end of the second trimester. Nurses can contribute to better health outcomes for both the mother and the baby by supporting the use of appropriate stress-coping methods in high-risk pregnant women. In addition to addressing the individual information needs of nurses, systematic training and consultation on nutrition, rest, activity, sexual life, fetal growth and development, potential complications, and fetal movement monitoring should be provided to reduce the stress levels of pregnant women at risk of preterm birth. It is believed that structuring the training and counseling program based on nursing theory will enhance the benefits provided.

This research is conducted based on the nursing theorist Neuman's Systems Model (NSM), which focuses on concepts such as stress, coping with stress, and the environment. The Neuman Systems Model offers a holistic approach to care, going beyond the traditional concept of illness. It emphasizes interdisciplinary approaches to disease treatment, prevention, health education, and health promotion. No previous studies were found that monitored the results of providing training and counseling to pregnant women at risk of preterm birth using the Neuman Systems Model. This study aims to present an innovative approach to reducing perceived stress, improving stress coping, and supporting positive birth outcomes in pregnant women at risk of preterm labor by implementing the Pregnant Nursing Education and Counseling Program (PNECP) structured on the Neuman Systems Model.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study
* 24-28. Being in the gestational week (this interval was chosen because the risk of preterm birth is usually determined at the 24th week of pregnancy and fetuses born between 24-28 weeks have the chance to live in special environments)
* Ability to read and write in Turkish
* Ability to use a smart phone or computer
* Ability to continue online training
* Being pregnant with only one baby
* Ability to participate in trainings

Exclusion Criteria:

* Refusal to participate in the research
* Being unable to read and write Turkish and/or be a foreign national
* Difficulty in understanding and perceiving
* Inability to use a smartphone or computer
* Having a previous diagnosis of a psychiatric illness (the patient or physician states that he or she has previously been diagnosed with schizophrenia, bipolar disorder, anxiety disorder, or used medication for this reason) from a psychiatrist.
* Multiple pregnancy
* The gestational week is less than 24 weeks and more than 28 weeks
* Continuous hospitalization

Primary outcomes:
measure: Risky Pregnancy Perceived Stress Question Form
timeFrame: 5 Minutes
measure: Styles of Coping with Stress Scale
timeFrame: 5 minutes
measure: Birth Outcome Evaluation Form
timeFrame: 10 minutes
measure: Pregnant women in the experimental group who applied the HEGDAP program, which was structured to the Neuman Systems Model, use more effective methods in coping with stress than before the program.
timeFrame: 1, minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Yakuti̇ye
country: Turkey
facility: Ayşe Metin
state: Erzurum
Study officials:
affiliation: Erzurum Technical University
name: Ayşe Metin
role: PRINCIPAL_INVESTIGATOR
References: