NCT07667920

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 4, 2026

Last Update Submit

June 19, 2026

Conditions

Keywords

Non-Stress TestPregnancyPainFearRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Anxiety Level

    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

Study Arms (3)

Affirmation Group 1

EXPERIMENTAL

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

Affirmation Group 2

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants in this arm did not receive the affirmation intervention during NST.

Interventions

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.

Affirmation Group 1Affirmation Group 2

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esenler Maternity and Child Diseases Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

June 4, 2026

First Posted

June 25, 2026

Study Start

November 10, 2025

Primary Completion

May 5, 2026

Study Completion

May 5, 2026

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations