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CompletedNCT06101186Updated Oct 26, 2023

The Effect of Nursing Counseling Perceived Stress, Coping and Birth Outcomes Among Pregnant Women

An interventional study of NPECP based on NSM in Preterm Birth, sponsored by Erzurum Technical University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-26.

Sponsored by Erzurum Technical University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Mar 2020, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Preterm Birth

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Keywords

  • Risk of Preterm Labor
  • Neuman Systems Model
  • Stress
  • Coping with Stress
  • Birth Outcomes
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 60 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Erzurum Technical University is the lead sponsor of 32 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    control group

    Participants in the control group received standard nursing care provided by the institution where the research was conducted. After the study, we shared the materials developed for NPECP with the participants in the control group.

  • Experimental
    Experimental group

    Nursing education and counseling practice to be applied to the experimental group was based on NSM. In the implementation of NPECP, the women were first met, and after the meeting, their informed consent was taken and they were included in the study. It was stated that the women in the experimental group were told that four scheduled interviews would be conducted online in a period of approximately 4 weeks. The women were given a telephone number where they could contact the researcher so that they could receive telephone/online counseling and were included in the whatsapp group with their permission.

    Other: NPECP based on NSM

Interventions

  • OtherNPECP based on NSM

    A comprehensive training booklet which integrated NPECP and NSM principles was sent to five experts for their evaluation and feedback. Among these experts, one was a physician who specialized in obstetrics and gynecology while the remaining individuals were nurses. Group training sessions were conducted online, with each group comprising 4-6 participants. These sessions spanned four weeks, with each session being held weekly and lasting for approximately 60-90 minutes. The training covered various topics - including pregnancy, pregnancy-related changes, pregnancy danger signs, premature birth, stress, stress symptoms, stress coping strategies, childbirth, the postpartum period and the challenges of parenting (particularly when dealing with a pre-term baby)

06

What researchers measure

Primary outcomes

  1. Risky Pregnancy Perceived Stress Question Form

    The Risky Pregnancy Perceived Stress Question Form (RPPS-QF) was developed by researchers to determine the stress perceived by pregnant women at high risk in the five life areas specified in the NSM. The RPPS-QF consists of a total of three dimensions and 35 items - comprised of the Physiological Domain (9 items), Psychological Domain (12 items) and Sociocultural-Developmental-Spiritual Domain (14 items). The Cronbach's alpha value of the form, prepared via a five-point Likert scale, is 0.86. The Cronbach's alpha value of the questionnaire was determined as 0.85 in the Psychological Domain, 0.67 in the Physiological Domain and 0.72 in the Sociocultural-Developmental-Spiritual Domain. As an individual's RPPS-QF score increases, it is held that their perceived stress increases.

    Time frame: 5 Minutes

  2. Styles of Coping with Stress Scale

    The Styles of Coping with Stress Scale (SCSS), as recorded via a 4-point Likert-type scale, was developed by Lazarus and Folkman.20 The Turkish validity of the 30-item form of the scale has been ascertained by Şahin and Durak.21 The Cronbach's alpha value of the scale was found to be 0.78. The scale covers the "seeking social support" (4 items), "optimistic" (5 items), "self-confident" (7 items), "helpless" (38 items) and "submissive" (6 items) approaches. The scale further consists of 5 sub-dimensions. Each item in the scale is assigned a score of between 0 and 3, whereby the scores for each factor are calculated separately. A higher score indicates that the person uses that style more.21 The Cronbach's alpha value of the scale in this study was determined as 0.89.

    Time frame: 5 minutes

  3. Birth Outcome Evaluation Form

    The Birth Outcome Evaluation Form was developed by researchers to assess postpartum maternal and newborn outcomes.13,22-25 It includes questions, for each birth, as to its birth type, whether it was full-term or pre-term, the presence of any complications for both the mother and the baby, the Apgar scores at the 1st and 5th minutes and the location in which the mother and baby are monitored.

    Time frame: 10 minutes

  4. 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.

    The Birth Outcome Evaluation Form was developed by researchers to assess postpartum maternal and newborn outcomes.13,22-25 It includes questions, for each birth, as to its birth type, whether it was full-term or pre-term, the presence of any complications for both the mother and the baby, the Apgar scores at the 1st and 5th minutes and the location in which the mother and baby are monitored.

    Time frame: 1, minutes

07

Study locations

1 site
  • Ayşe Metin
    Yakuti̇ye, Erzurum, Turkey
08

References and documents

Study documents

  • Protocol, analysis plan and consent form · Dec 27, 2019

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06101186
Lead sponsor
Erzurum Technical University
Collaborators
Ondokuz Mayıs University
Responsible party
Ayşe Metin (Assistan Proffesor, Erzurum Technical University) — Principal investigator
First posted
Oct 26, 2023
Start date
Mar 30, 2020
Primary completion
Jun 30, 2021
Completion
Jul 30, 2021
Last update
Oct 26, 2023

Study contacts

Ayşe Metin
principal investigator · Erzurum Technical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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