PregnancyNST-AFFIRMATIONCT07667920
The Effect of Affirmation During Non-Stress Test on Pain, Anxiety, Fear, and Stress
A study testing Affirmation Practice During Non-Stress Test in people with Pregnancy and Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- What is being tested?
- Affirmation Practice During Non-Stress Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2025to 5 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Esenler Maternity and Child Diseases Hospital
Istanbul, 34668
About this study
Official title: 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.
- Being tested
- Affirmation Practice During Non-Stress Test
- Keywords
- Non-Stress Test, Pregnancy, Pain, Fear, Randomized Controlled Trial
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affirmation Practice During Non-Stress TestBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Affirmation Practice During Non-Stress Test |
| Control Group | No intervention | Participants in this arm did not receive the affirmation intervention during NST. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and immediately after the Non-Stress Test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start10 Nov 2025
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enzel Köksaldı, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667920
- Sponsor's protocol ID
- 2025/11
- Other IDs
- 1919B012401664
- Acronym
- NST-AFFIRMATIO
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Affirmation During Non-Stress Test on Pain, Anxiety, Fear, and Stress: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07667920
- Acronym / sponsor ID
- NST-AFFIRMATIO / 2025/11
- Keywords
- Non-Stress Test, Pregnancy, Pain, Fear, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Affirmation Group 1 | Experimental | Behavioral: Affirmation Practice During Non-Stress TestPregnant 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. |
| Affirmation Group 2 | Experimental | Behavioral: Affirmation Practice During Non-Stress TestPregnant 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. |
| Control Group | No intervention | –Participants in this arm did not receive the affirmation intervention during NST. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affirmation Practice During Non-Stress TestPregnant 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. | Behavioural | Affirmation Group 1, Affirmation Group 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affirmation Practice During Non-Stress Test in people with Pregnancy and Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Level (time frame: Before and immediately after the Non-Stress Test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.