The Effect of Affirmation During Non-Stress Test on Pain, Anxiety, Fear, and Stress (NST-AFFIRMATIO)

June 19, 2026 updated by: Enzel Köksaldı, Saglik Bilimleri Universitesi

The Effect of Affirmation During Non-Stress Test on Pain, Anxiety, Fear, and Stress: A Randomized Controlled Trial

This study will examine whether positive affirmations used during the Non-Stress Test (NST) can help reduce pain, anxiety, fear, and stress in pregnant women. The NST is a routine test used during pregnancy to assess fetal well-being. In this randomized controlled study, 90 pregnant women will participate. Some participants will repeat affirmation statements during the NST, while others will receive standard care. Pain, anxiety, fear, and stress levels will be measured before and after the NST. The goal of the study is to understand whether affirmations can make the NST experience more comfortable for pregnant women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34668
        • Esenler Maternity and Child Diseases Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women admitted to the clinic for the Non-Stress Test
  • Pregnant women between 32 and 41 weeks of gestation
  • Turkish citizens
  • Women aged 20 to 35 years
  • Women who voluntarily agree to participate in the study and provide informed consent
  • Women who have emptied their bladder immediately before the NST
  • Women who have eaten at least two hours before the NST

Exclusion Criteria:

  • High-risk pregnancy, such as preeclampsia or multiple pregnancy
  • Inability to read and write Turkish
  • Any health problem in the mother or fetus
  • Known psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Affirmation Group 1
Pregnant women with a normal pregnancy process will receive affirmation practice during the Non-Stress Test. During the NST procedure, participants will repeat positive affirmation statements to support relaxation and reduce pain, anxiety, fear, and stress.
Behavioral: Affirmation Practice During Non-Stress Test
Pregnant women in the affirmation groups will repeat positive affirmation statements during the Non-Stress Test. The affirmation practice will be applied during the NST procedure to support relaxation and reduce pain, anxiety, fear, and stress.
Experimental: Affirmation Group 2
Pregnant women who require a repeated Non-Stress Test due to decreased fetal movements or pain will receive affirmation practice during the Non-Stress Test. During the NST procedure, participants will repeat positive affirmation statements to support relaxation and reduce pain, anxiety, fear, and stress.
Behavioral: Affirmation Practice During Non-Stress Test
Pregnant women in the affirmation groups will repeat positive affirmation statements during the Non-Stress Test. The affirmation practice will be applied during the NST procedure to support relaxation and reduce pain, anxiety, fear, and stress.
No Intervention: Control Group
Participants in this arm did not receive the affirmation intervention during NST.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Level
Time Frame: Before and immediately after the Non-Stress Test
Anxiety level will be assessed using the State Anxiety Inventory before and after the Non-Stress Test. Higher scores indicate higher anxiety levels.
Before and immediately after the Non-Stress Test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Actual)

May 5, 2026

Study Completion (Actual)

May 5, 2026

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/11
  • 1919B012401664 (Other Grant/Funding Number: TUBITAK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the study includes sensitive health-related data from pregnant women. Participant confidentiality and privacy will be protected, and the data will be used only for the purposes of this study and related scientific reporting.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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