CompletedNot Applicable

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

Turkey (Türkiye)100 participantsStarted 2024-04-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Not willing to participate in the study * Presence of a fetal anomaly * Risk of fetal loss * Having previously received childbirth preparation education

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT06795633

SponsorUskudar University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-14

View on ClinicalTrials.gov More High-risk Pregnancy trials