Affirmation-Based Information for Stress Reduction in High-Risk Pregnancy

NCT07407322 | Completed

• 1 other identifier: Stress Reduction in High-Risk
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study examined whether providing affirmation-based information to high-risk pregnant women admitted to the obstetrics emergency department could reduce stress levels and intolerance of uncertainty. High-risk pregnancy can be emotionally challenging, especially in emergency settings, and supportive communication may help women cope with stress during this period. In this randomized controlled trial, pregnant women diagnosed with high-risk pregnancy were assigned either to an intervention group that received routine emergency care along with verbal information and positive affirmation statements, or to a control group that received routine emergency care and verbal information only. Stress levels and intolerance of uncertainty were measured before and after the intervention using validated assessment tools. The findings of this study aim to contribute to evidence-based supportive care practices in obstetric emergency settings and to inform health care professionals about non-pharmacological approaches to improving emotional well-being in high-risk pregnant women.

Conditions

High-risk Pregnancy

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Level

  Change in perceived stress measured by the Neuman Systems Model-Based Perceived Stress Scale for High-Risk Pregnancy.

  Baseline and immediately after the intervention during emergency department observation

Secondary Outcomes (1)

• Intolerance of Uncertainty

  Baseline and immediately after the intervention

Study Arms (2)

Affirmation-Based Information

EXPERIMENTAL

Pregnant women received routine emergency obstetric care, structured verbal information about the emergency unit and their current condition, followed by affirmation statements delivered verbally in a calm and supportive tone during non-stress test monitoring.

Behavioral: Affirmation + Information Group

Control group

NO INTERVENTION

Pregnant women received routine emergency obstetric care and structured verbal information about the emergency unit and their current condition during non-stress test monitoring.

Interventions

Affirmation + Information Group BEHAVIORAL

Pregnant women received routine emergency obstetric care, structured verbal information about the emergency unit and their current condition, followed by affirmation statements delivered verbally in a calm and supportive tone during non-stress test monitoring.

Affirmation-Based Information

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years and older
• Gestational age of 32 weeks or above
• Diagnosed with high-risk pregnancy
• Admitted to the obstetrics emergency department
• Volunteered to participate and provided written informed consent

You may not qualify if:

• Inability to communicate in Turkish
• No diagnosis of high-risk pregnancy

Sponsors & Collaborators

• Nilgun Avci: lead

Study Sites (1)

State Obstetrics and Gynecology Hospital, Istanbul

Bayrampaşa, Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: phD

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: July 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)