Effect of Light Color on Stress, Anxiety, and Psychological Well-being During Nonstress Test in Pregnant Women at Risk

December 15, 2024 updated by: Emine Yıldırım, Osmaniye Korkut Ata University

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

Not yet recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 25, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 15, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 15, 2024

Last Verified

December 1, 2024

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)?

NO

IPD Plan Description

Can be shared when necessary.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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