Effect of Light Level on Stress, Anxiety, Psychological W... | NCT06504810

Studies
Effect of Light Level on Stress, Anxiety, Psychological Well-being in Pregnant Women

NCT06504810

Sponsor

Emine Yıldırım

Status

Not yet recruiting

Last Update Posted

Jul 17, 2024Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Stress
Anxiety
Pregnant Women

Interventions

light

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2024Estimated

Primary Completion Date

Jul 26, 2024Estimated

Completion Date

Aug 25, 2024Estimated

First Submitted Date

Jul 10, 2024

First Submission Date that Met QC Criteria

Jul 16, 2024

First Posted Date

Jul 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2024

Last Update Posted Date

Jul 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine the effect of light level on stress, anxiety and psychological well-being in pregnant women. This research was planned as a single-blind, randomized controlled experimental type study by comparing separate groups as experiment-placebo control. Data will be collected using the Introductory Information Form, Psychological Well-Being Scale, Perceived Stress Scale (ASÖ/PSÖ-14), and State-Trait Anxiety Inventory (STAI). The effect of two different amounts of light on pregnant women will be evaluated.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo group	Placebo Comparator		Other: light
experimental group	Experimental		Other: light

Interventions

Name	Type	Description	Arm Group Labels	Other Names
light	Other	light level	experimental group placebo group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
stress	stress scale	1 day

Secondary Outcomes

Measure	Description	Time Frame
anxiety	anxiety scale	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being 18 years or older,
being in the last trimester of pregnancy,
volunteering.

Exclusion Criteria:

Having any problems that prevent you from communicating

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42029912	Derived	Yildirim E, Polat F. Effect of Reduced Lighting on Psychological Well-Being During a Non-Stress Test in Pregnant Women: A Randomized Controlled Study. HERD. 2026 Jul;19(3):101-111. doi: 10.1177/19375867261438793. Epub 2026 Apr 24.

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena