Pregnant WomenNCT06736873
Effect of Light Color on Stress, Anxiety, and Psychological Well-being During Nonstress Test in Pregnant Women at Risk
A study testing Light intervention in people with Pregnant Women and Stress, run by Osmaniye Korkut Ata University.
Trial summary
Purpose of the research: To determine the effect of light color on stress, anxiety, and psychological well-being during the Nonstress Test in at-risk pregnant women. This research was planned as a single-blind randomized controlled experimental type study by comparing separate groups in the form of experiment-placebo… Read more about this study
- Who is it for?
- Ages 18 to 45 hours, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Stress, Light
- What is being tested?
- Light intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 hours
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Being at risk of pregnancy,
- being in the last trimester of pregnancy,
- being a volunteer.
Who cannot join
- Having any problem that prevents communication (such as not knowing Turkish, having hearing, speaking and understanding disorders),
- being on psychiatric treatment (pharmacotherapy or psychotherapy),
- having a disease in their eyes that prevents them from seeing
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Light Color on Stress, Anxiety, and Psychological Well-being During Nonstress Test in Pregnant Women at Risk: A Randomized Placebo-controlled Study
Purpose of the research:
To determine the effect of light color on stress, anxiety, and psychological well-being during the Nonstress Test in at-risk pregnant women. This research was planned as a single-blind randomized controlled experimental type study by comparing separate groups in the form of experiment-placebo control. Data will be collected with the Introductory Information Form, Psychological Well-being Scale, Perceived Stress Scale (PSS/PSS-14), State Trait Anxiety Inventory (STAI). The NST device is used to follow up pregnant women in the last 3 months of pregnancy, first monthly, then every two weeks and once a week. In other words, the procedure is routinely performed on every pregnant woman who comes for control. It is a device that shows the well-being of the baby and whether the mother has contractions. It is attached to the pregnant woman's abdominal area and does not cause any harm. It is not an invasive procedure. Pregnant women in the last 3 months of pregnancy who come to have NST for follow-up will be randomly selected and divided into 2 groups. A lamp with adjustable light level with Unit Unit Ut-383 Mini Luxmeter (Light Meter) will be placed in the intervention and control groups and the light level of the lamp will be adjusted to 100 lux. NST will be taken under cold (bluish white) light for the control group and under medium warm white (daylight white) light for the intervention group. Pre-test before the application and post-test after the application will be applied. The application is an invasive application that will not disturb the pregnant woman.
- Conditions
- Pregnant Women, Stress, Light
- Being tested
- Light intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light interventionOther
Light intervention
| Study group | Role | What they receive |
|---|---|---|
| light application | Experimental | Non-stress test was performed under 100 lx light application. Receives: Other: Light intervention |
| control group | Placebo comparator | Non-stress test was performed under 440 lx light application. Receives: Other: Light intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress scale
questionnaire
Measured: 2 minutes
anxiety scale
questionnaire
Measured: 2 minutes
psychological well-being scale
questionnaire
Measured: 1 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start25 Dec 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Yıldırım, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736873
- Sponsor's protocol ID
- 205323
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Can be shared when necessary.
Publications
Yildirim E, Polat F. Light color temperature on stress, anxiety and well-being in high-risk pregnant women during the non-stress test: a randomized controlled trial. Reprod Health. 2026 Feb 24;23(1):50. doi: 10.1186/s12978-026-02280-6.
PubMed 41731583
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Light Color on Stress, Anxiety, and Psychological Well-being During Nonstress Test in Pregnant Women at Risk: A Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06736873
- Acronym / sponsor ID
- 205323
- Conditions
- Pregnant Women, Stress, Light
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 25 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 17 Dec 2024 (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.
Purpose of the research:
To determine the effect of light color on stress, anxiety, and psychological well-being during the Nonstress Test in at-risk pregnant women. This research was planned as a single-blind randomized controlled experimental type study by comparing separate groups in the form of experiment-placebo control. Data will be collected with the Introductory Information Form, Psychological Well-being Scale, Perceived Stress Scale (PSS/PSS-14), State Trait Anxiety Inventory (STAI). The NST device is used to follow up pregnant women in the last 3 months of pregnancy, first monthly, then every two weeks and once a week. In other words, the procedure is routinely performed on every pregnant woman who comes for control. It is a device that shows the well-being of the baby and whether the mother has contractions. It is attached to the pregnant woman's abdominal area and does not cause any harm. It is not an invasive procedure. Pregnant women in the last 3 months of pregnancy who come to have NST for follow-up will be randomly selected and divided into 2 groups. A lamp with adjustable light level with Unit Unit Ut-383 Mini Luxmeter (Light Meter) will be placed in the intervention and control groups and the light level of the lamp will be adjusted to 100 lux. NST will be taken under cold (bluish white) light for the control group and under medium warm white (daylight white) light for the intervention group. Pre-test before the application and post-test after the application will be applied. The application is an invasive application that will not disturb the pregnant woman.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| light application | Experimental | Other: Light interventionNon-stress test was performed under 100 lx light application. |
| control group | Placebo comparator | Other: Light interventionNon-stress test was performed under 440 lx light application. |
Who may qualify
- Ages
- 18 to 45 hours
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Being at risk of pregnancy,
- being in the last trimester of pregnancy,
- being a volunteer.
Key exclusion criteria (3 listed)
- Having any problem that prevents communication (such as not knowing Turkish, having hearing, speaking and understanding disorders),
- being on psychiatric treatment (pharmacotherapy or psychotherapy),
- having a disease in their eyes that prevents them from seeing
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 |
|---|---|---|
| Light interventionLight intervention | Other | control group, light application |
Primary outcome
stress scale
Time frame: 2 minutes
questionnaire
anxiety scale
Time frame: 2 minutes
questionnaire
psychological well-being scale
Time frame: 1 minutes
questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Derived from this study: PubMed 41731583Yildirim E, Polat F. Light color temperature on stress, anxiety and well-being in high-risk pregnant women during the non-stress test: a randomized controlled trial. Reprod Health. 2026 Feb 24;23(1):50. doi: 10.1186/s12978-026-02280-6.
- Individual participant dataSharing planned: No. Can be shared when necessary.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Light intervention in people with Pregnant Women and Stress, run by Osmaniye Korkut Ata University.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emine Yıldırım, Assistant Professor (05066268672, eminekucukyildirim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stress scale (time frame: 2 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06736873, which also lists 1 linked publication.
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 17 Dec 2024.