NCT06101186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

September 27, 2023

Last Update Submit

October 23, 2023

Conditions

Keywords

Risk of Preterm LaborNeuman Systems ModelStressCoping with StressBirth Outcomes

Outcome Measures

Primary Outcomes (4)

  • 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.

    5 Minutes

  • 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.

    5 minutes

  • 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.

    10 minutes

  • 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.

    1, minutes

Study Arms (2)

control group

NO INTERVENTION

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 group

EXPERIMENTAL

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

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)

Experimental group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering to participate in the study
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşe Metin

Yakutiye, Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ayşe Metin

    Erzurum Technical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistan Proffesor

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 26, 2023

Study Start

March 30, 2020

Primary Completion

June 30, 2021

Study Completion

July 30, 2021

Last Updated

October 26, 2023

Record last verified: 2023-10

Locations