NCT06736873

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

December 25, 2024

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

5 days

First QC Date

December 5, 2024

Last Update Submit

December 15, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • stress scale

    questionnaire

    2 minutes

  • anxiety scale

    questionnaire

    2 minutes

  • psychological well-being scale

    questionnaire

    1 minutes

Study Arms (2)

light application

EXPERIMENTAL

Non-stress test was performed under 100 lx light application.

Other: Light intervention

control group

PLACEBO COMPARATOR

Non-stress test was performed under 440 lx light application.

Other: Light intervention

Interventions

Light intervention

control grouplight application

Eligibility Criteria

Age18 Hours - 45 Hours
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being at risk of pregnancy,
  • being in the last trimester of pregnancy,
  • being a volunteer.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Emine Yıldırım, Assistant Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 17, 2024

Study Start

December 25, 2024

Primary Completion

December 30, 2024

Study Completion

January 15, 2025

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Can be shared when necessary.