NCT06504823

Brief Summary

To determine the effect of the light level applied during breastfeeding on the mother's stress, anxiety, psychological well-being and breastfeeding motivation. This research was planned as a single-blind randomized controlled experimental type study comparing separate groups as intervention-placebo controlled. Data will be collected with the Introductory Information Form, Psychological Well-Being Scale, Perceived Stress Scale (ASÖ/PSÖ-14), State-Trait Anxiety Inventory (STAI) and Breastfeeding Motivation Scale (For Primiparous Mothers). The effect of two different light levels on mothers will be examined.

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

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

July 10, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

July 22, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

4 days

First QC Date

July 10, 2024

Last Update Submit

July 16, 2024

Conditions

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 level

experimental group

EXPERIMENTAL
Other: Light level

Interventions

light application

experimental groupplacebo group

Eligibility Criteria

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

You may qualify if:

  • being 18 years of age or older, volunteering.

You may not qualify if:

  • Having any problem that prevents communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

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 22, 2024

Primary Completion

July 26, 2024

Study Completion

August 2, 2024

Last Updated

July 17, 2024

Record last verified: 2024-07