High-risk PregnancyNCT07407322
Affirmation-Based Information for Stress Reduction in High-Risk Pregnancy
A study testing Affirmation + Information Group in people with High-risk Pregnancy, run by Nilgun Avci at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High-risk Pregnancy
- What is being tested?
- Affirmation + Information Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 31 Jan 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to communicate in Turkish
- No diagnosis of high-risk pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
State Obstetrics and Gynecology Hospital, Istanbul
Bayrampaşa, Istanbul
About this study
Official title: 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.
- Conditions
- High-risk Pregnancy
- Being tested
- Affirmation + Information Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affirmation + Information GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Level
Change in perceived stress measured by the Neuman Systems Model-Based Perceived Stress Scale for High-Risk Pregnancy.
Measured: Baseline and immediately after the intervention during emergency department observation
Secondary outcomes (1)
Intolerance of Uncertainty
Change in intolerance of uncertainty measured by the Intolerance of Uncertainty Scale.
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Jul 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk PregnancyStudies of the same condition, open and under way.
- 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nilgun Avci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nilgun Avci, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407322
- Sponsor's protocol ID
- Stress Reduction in High-Risk
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07407322
- Acronym / sponsor ID
- Stress Reduction in High-Risk
- Conditions
- High-risk Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Nilgun AvciUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 12 Feb 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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affirmation-Based Information | Experimental | Behavioral: Affirmation + Information GroupPregnant 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to communicate in Turkish
- No diagnosis of high-risk pregnancy
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 + Information GroupPregnant 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. | Behavioural | Affirmation-Based Information |
Primary outcome
Perceived Stress Level
Time frame: Baseline and immediately after the intervention during emergency department observation
Change in perceived stress measured by the Neuman Systems Model-Based Perceived Stress Scale for High-Risk Pregnancy.
1 secondary outcome
Intolerance of Uncertainty
Time frame: Baseline and immediately after the intervention
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 12 Feb 2026.
- Individual participant dataSharing planned: No
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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 + Information Group in people with High-risk Pregnancy, run by Nilgun Avci 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 5 inclusion and 2 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 12 Feb 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?
Perceived Stress Level (time frame: Baseline and immediately after the intervention during emergency department observation). 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 12 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.