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High-risk PregnancyRGYBBPNCT06795633

The Impact of a Holistic Care Program for High-Risk Pregnancies on Stress and Mental Health

A study testing Holistic Care Program for High-Risk Pregnancies in people with High-risk Pregnancy and Holistic Care, run by Uskudar University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate the effects of the Holistic Care Program for High-Risk Pregnancies on the stress levels and mental health of pregnant women. Within this framework, the study seeks to examine the potential of the holistic care program to strengthen stress coping mechanisms, positively influence… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
High-risk Pregnancy, Holistic Care, Stress
What is being tested?
Holistic Care Program for High-Risk Pregnancies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Apr 2024to 30 Oct 2024
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Being willing to participate in the study and over the age of 18,
  • Ability to understand and speak Turkish,
  • Being a primiparous woman,
  • Being in the third trimester of pregnancy.
  • Being hospitalized in the perinatology ward and receiving care for at least 3 days
  • Having at least one diagnosed high-risk pregnancy condition

Who cannot join

  • Not willing to participate in the study
  • Presence of a fetal anomaly
  • Risk of fetal loss
  • Having previously received childbirth preparation education

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Uskudar Univercity

    Istanbul, ümraniye, 34000

  • Üsküdar Üniversitesi

    Istanbul, ümraniye, 34000

Other trials in Turkey (Türkiye)

About this study

The aim of this study is to evaluate the effects of the Holistic Care Program for High-Risk Pregnancies on the stress levels and mental health of pregnant women. Within this framework, the study seeks to examine the potential of the holistic care program to strengthen stress coping mechanisms, positively influence mental health, and enhance general health awareness among high-risk pregnant women.

The study was conducted using a randomized controlled trial design between April 1, 2024, and December 31, 2024, at a maternity hospital in Istanbul. A total of 100 high-risk pregnant women were randomized into two groups: 50 participants were assigned to the group receiving the holistic care program along with routine midwifery care (intervention), and 50 were assigned to the group receiving only routine midwifery care (control).

Read more

The Holistic Care Program for High-Risk Pregnancies consists of three sessions: Physiological Information and Preparation for High-Risk Pregnancy, Psychological Support and Preparation, and Creative Practices and Final Evaluation.

Research data were collected using five forms: Informed Consent Form, Demographic Information Form, Perceived Stress Scale for High-Risk Pregnancies Based on Neuman Systems Model, Brief Symptom Inventory, and Holistic Care Program Evaluation Form for High-Risk Pregnancies.

Read the detailed description

Introduction: The presence of increased health risks or complications for either the mother, the fetus, or both during pregnancy or childbirth is referred to as high-risk pregnancy. Visual and socially enriched individualized educational programs for high-risk pregnancies are emerging as an essential component of providing holistic care that addresses medical and emotional needs. These educational programs aim to reduce stress and uncertainty that pregnant women may encounter during the perinatal period by helping them better understand their health conditions and the baby's condition. It is believed that individualized education provided to high-risk pregnant women receiving care in perinatology clinics can strengthen their stress-coping mechanisms and allow them to respond more effectively to emotional needs during this period.

Objective: This study aims to evaluate the effects of a holistic care program on the stress levels and mental health of high-risk pregnant women. In this context, the study seeks to explore the program's potential to enhance stress-coping mechanisms, positively influence mental health, and increase overall health awareness among high-risk pregnant women.

Methods: The study was conducted as a randomized controlled trial in the pregnancy follow-up outpatient clinic of a maternity hospital in Istanbul between April 1, 2024, and December 31, 2024. A total of 100 pregnant women were included in the study and randomly assigned to one of two groups:

Intervention Group: 50 participants Control Group: 50 participants Data were collected at two time points: a pre-test on the first day of group assignment and a post-test on the day of discharge. Research data were gathered through face-to-face interviews using five forms: Informed Consent Form, Demographic Information Form, Perceived Stress Scale for High-Risk Pregnancies Based on Neuman Systems Model, Brief Symptom Inventory, and Holistic Care Program Evaluation Form for High-Risk Pregnancies.

The intervention group received midwifery counseling and care accompanied by the Holistic Care Program for High-Risk Pregnancies. The control group received only the standard midwifery care provided by the clinic.

Intervention Group Applications: High-risk pregnant women admitted to the perinatology clinic and assigned to the intervention group participated in a Holistic Care Program for High-Risk Pregnancies in addition to the midwifery care provided at the clinic. The implementation of the program involved two phases: preparation and application.

Preparation Phase: The content of the Holistic Care Program for High-Risk Pregnancies, shaped by Neuman's Systems Model, was developed. Existing childbirth preparation programs and topics essential to high-risk pregnancy counseling were considered. Experts, including childbirth preparation instructors and academic midwifery professionals (2 Professors, 3 Associate Professors, 3 Assistant Professors, 2 Research Assistants, and 1 Lecturer), reviewed the program, and modifications were made based on their recommendations.

Application Phase: After finalizing the program content, the education sessions were scheduled. Sessions were held in a dedicated clinical space, taking into account clinical conditions, working schedules, and the treatment hours of the participants. The total program duration was planned for 6 hours and 15 minutes, delivered across three sessions and six meetings.

Session 1: Group education focused on physiological information and preparation from high-risk pregnancy to childbirth. This 2-hour session, conducted in two meetings, covered physiological aspects, body structures, and functions.

Session 2: Individual education focused on psychological support and preparation, aiming to enhance emotional resilience during pregnancy. This 2-hour session, conducted in two meetings, addressed psychological, sociocultural, and spiritual aspects of life.

Session 3: Group education titled "The Compassion of Hands: Bonding and Relaxation Techniques During Pregnancy" was conducted as a 2-hour and 15-minute session. This session focused on spiritual and emotional aspects, emphasizing bonding between the pregnant woman and her baby.

Control Group Applications: Routine midwifery care procedures followed in the perinatology clinic were applied to the control group.

Data Analysis: Data were analyzed using SPSS (Statistical Package for Social Sciences) for Windows 25.0. Descriptive statistical analyses (frequency, percentage, minimum-maximum values, median, mean, and standard deviation) were employed. The suitability of data for normal distribution was tested using Kolmogorov-Smirnov and Shapiro-Wilk tests.

Being tested
Holistic Care Program for High-Risk Pregnancies
Keywords
Holistic Care Practices, High-Risk Pregnancy, Midwifery, High-Risk Pregnancy School
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Holistic Care Program for High-Risk PregnanciesOther

    High-risk pregnant women admitted to the perinatology clinic participated in the Holistic Care Program for High-Risk Pregnancies in addition to the midwifery care provided in the clinic.

Study groups in NCT06795633
Study groupRoleWhat they receive
Intervention GroupExperimentalIntervention Group Applications: High-risk pregnant women admitted to the perinatology clinic and assigned to the intervention group participated in a Holistic Care Program for High-Risk Pregnancies in addition to the midwifery care provided at the clinic.
Receives: Other: Holistic Care Program for High-Risk Pregnancies
Control GroupNo interventionControl Group Applications: Routine midwifery care procedures followed in the perinatology clinic were applied to the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. "Perceived Stress Scale in High-Risk Pregnancies Based on the Neuman Systems Model (PSS-HRP-NSM)"

    The scale consists of 34 items covering five life domains outlined in the Neuman Systems Model: physiological, psychological, sociocultural, developmental, and spiritual. It is a five-point Likert scale ranging from "Never (1)" to "Always (5)," with total scores ranging between 34 and 170. The sum of subscale scores reflects stress levels in the respective life domains, while the total score indicates overall stress levels. Items 22, 30, 31, 32, and 33 are reverse-coded. In the original study, the overall Cronbach's Alpha value was found to be 0.87, whereas, in this study, it was determined to be 0.954. Subscale Cronbach's Alpha values were calculated as 0.892 for the physiological domain, 0.911 for the psychological domain, and 0.867 for the sociocultural/developmental/spiritual domain. The scale was administered to both intervention and control groups as pre-test and post-test in this study, with higher scores indicating higher perceived stress levels in the respective life domains

    Measured: At the end of the 3-day holistic care program

Secondary outcomes (1)
  1. Brief Symptom Inventory (BSI)

    The Brief Symptom Inventory (BSI), developed by Derogatis (1992), is a 53-item shortened version of the SCL-90-R, measuring psychological symptoms across five subscales: anxiety, depression, negative self-concept, somatization, and hostility. Responses are recorded on a 5-point Likert scale (0: Not at all, 4: Extremely), with higher scores indicating greater psychological distress. In the Turkish validation by Şahin et al. (2002), Cronbach's Alpha values ranged from 0.70 to 0.88, with an overall reliability of 0.94.

    In this study, the BSI showed an overall Cronbach's Alpha of 0.969. Subscale reliabilities were 0.869 for anxiety, 0.922 for depression, 0.900 for negative self-concept, 0.831 for somatization, and 0.844 for hostility. The scale was applied as both pre-test and post-test, with higher scores indicating increased psychological symptoms.

    Measured: At the end of the 3-day holistic care program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2025
  2. Study start1 Apr 2024
  3. Primary completion14 Jun 2024
  4. Study completion30 Oct 2024

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Intervention Group (50 participants): Received the holistic care program and routine midwifery care. Control Group (50 participants): Received routine midwifery care. Data were collected at two time points: a pre-test on the first day of group assignment and a post-test on the day of discharge.
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06795633
Sponsor's protocol ID
RGYBBP
Acronym
RGYBBP
Status last verified
Jan 2025
First submitted
21 Jan 2025
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data requested by the researcher will be shared by the researcher in accordance with the confirmation of its intended use.

Publications

  • Carolan-Olah M, Sayakhot P. A randomized controlled trial of a web-based education intervention for women with gestational diabetes mellitus. Midwifery. 2019 Jan;68:39-47. doi: 10.1016/j.midw.2018.08.019. Epub 2018 Sep 5.

    PubMed 30343264
  • Schiele C, Goetz M, Hassdenteufel K, Muller M, Graf J, Zipfel S, Wallwiener S. Acceptance, experiences, and needs of hospitalized pregnant women toward an electronic mindfulness-based intervention: A pilot mixed-methods study. Front Psychiatry. 2022 Aug 22;13:939577. doi: 10.3389/fpsyt.2022.939577. eCollection 2022.

    PubMed 36072461
  • Anolak H, Lau F, Davis D, Browne J, Watt B. Creative arts intervention in support of women experiencing a high-risk pregnancy: A qualitative descriptive thematic analysis. Sex Reprod Healthc. 2023 Jun;36:100830. doi: 10.1016/j.srhc.2023.100830. Epub 2023 Mar 3.

    PubMed 36898309

Questions about this trial

What is this clinical trial studying?

A study testing Holistic Care Program for High-Risk Pregnancies in people with High-risk Pregnancy and Holistic Care, run by Uskudar University at 2 sites 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 6 inclusion and 4 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 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

"Perceived Stress Scale in High-Risk Pregnancies Based on the Neuman Systems Model (PSS-HRP-NSM)" (time frame: At the end of the 3-day holistic care program). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06795633, which also lists 3 linked publications.

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 11 Feb 2025.

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