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

Effect of Affirmation-Based Information on Stress and Intolerance of Uncertainty in High-Risk Pregnant Women Admitted to the Emergency Department: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: High-risk Pregnancy
• Intervention / Treatment: Behavioral: Affirmation + Information Group

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Bayrampaşa, Istanbul, Turkey (Türkiye)
      • State Obstetrics and Gynecology Hospital, Istanbul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Affirmation-Based Information; 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; 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.
No Intervention: Control group; Pregnant women received routine emergency obstetric care and structured verbal information about the emergency unit and their current condition during non-stress test monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intolerance of Uncertainty	Change in intolerance of uncertainty measured by the Intolerance of Uncertainty Scale.	Baseline and immediately after the intervention

Collaborators and Investigators

• Sponsor: Nilgun Avci

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Stress Reduction in High-Risk

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No