- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06736873
Effect of Light Color on Stress, Anxiety, and Psychological Well-being During Nonstress Test in Pregnant Women at Risk
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emine Yıldırım, Assistant Professor
- Phone Number: 05066268672
- Email: eminekucukyildirim@gmail.com
Study Contact Backup
- Name: Filiz POLAT
- Phone Number: 05066268672
- Email: filizmermer@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being at risk of pregnancy,
- being in the last trimester of pregnancy,
- being a volunteer.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: light application
Non-stress test was performed under 100 lx light application.
|
Light intervention
|
|
Placebo Comparator: control group
Non-stress test was performed under 440 lx light application.
|
Light intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
stress scale
Time Frame: 2 minutes
|
questionnaire
|
2 minutes
|
|
anxiety scale
Time Frame: 2 minutes
|
questionnaire
|
2 minutes
|
|
psychological well-being scale
Time Frame: 1 minutes
|
questionnaire
|
1 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 205323
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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