NCT06504810

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.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

July 25, 2024

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

1 day

First QC Date

July 10, 2024

Last Update Submit

July 16, 2024

Conditions

StressAnxietyPregnant Women

Outcome Measures

Primary Outcomes (1)

  • stress

    stress scale

    1 day

Secondary Outcomes (1)

  • anxiety

    1 day

Study Arms (2)

placebo group

PLACEBO COMPARATOR
Other: light

experimental group

EXPERIMENTAL
Other: light

Interventions

lightOTHER

light level

experimental groupplacebo group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Having any problems that prevent you from communicating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Light

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaOptical PhenomenaRadiationRadiation, Nonionizing

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
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 17, 2024

Study Start

July 25, 2024

Primary Completion

July 26, 2024

Study Completion

August 25, 2024

Last Updated

July 17, 2024

Record last verified: 2024-07