Preterm BirthNCT06101186
The Effect of Nursing Counseling Perceived Stress, Coping and Birth Outcomes Among Pregnant Women
A study testing NPECP based on NSM in people with Preterm Birth, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- NPECP based on NSM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Preterm Birth
- Being tested
- NPECP based on NSM
- Keywords
- Risk of Preterm Labor, Neuman Systems Model, Stress, Coping with Stress, Birth Outcomes
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPECP based on NSMOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: NPECP based on NSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1, minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start30 Mar 2020
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Principal investigator, Ayşe Metin, Erzurum Technical University
- Investigators
- Ayşe Metin, Principal investigator, Erzurum Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101186
- Sponsor's protocol ID
- 040818
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06101186
- Acronym / sponsor ID
- 040818
- Conditions
- Preterm Birth
- Keywords
- Risk of Preterm Labor, Neuman Systems Model, Stress, Coping with Stress, Birth Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: NPECP based on NSMNursing 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPECP based on NSMA 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) | Other | Experimental group |
Primary outcome
Risky Pregnancy Perceived Stress Question Form
Time frame: 5 Minutes
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.
Styles of Coping with Stress Scale
Time frame: 5 minutes
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.
Birth Outcome Evaluation Form
Time frame: 10 minutes
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.
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.
Time frame: 1, minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe Metin principal investigator
Erzurum Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NPECP based on NSM in people with Preterm Birth, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risky Pregnancy Perceived Stress Question Form (time frame: 5 Minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.