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

NCT06795633 | Completed

• 1 other identifier: RGYBBP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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 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). 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.

Conditions

High-risk Pregnancy; Holistic Care; Stress; Prenatal Stress; Mental Health; Midwifery Support; Midwifery; Pregnancy; High-Risk Pregnancy School

Keywords

Holistic Care Practices; High-Risk Pregnancy; Midwifery; High-Risk Pregnancy School

Outcome Measures

Primary Outcomes (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

  At the end of the 3-day holistic care program

Secondary Outcomes (1)

• Brief Symptom Inventory (BSI)

  At the end of the 3-day holistic care program

Other Outcomes (1)

• Evaluation Form for the Holistic Care Program in High-Risk Pregnancies

  At the end of the 3-day holistic care program

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Holistic Care Program for High-Risk Pregnancies

Control Group

NO INTERVENTION

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

Interventions

Holistic Care Program for High-Risk Pregnancies OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (2)

Uskudar Univercity

Istanbul, ümraniye, 34000, Turkey (Türkiye)

Location

Üsküdar Üniversitesi

Istanbul, ümraniye, 34000, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30343264 BACKGROUND

• 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.

  PMID: 36072461 BACKGROUND

• 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.

  PMID: 36898309 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Pregnancy, High-Risk

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-dean

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 28, 2025
• Study Start: April 1, 2024
• Primary Completion: June 14, 2024
• Study Completion: October 30, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

TU (2)