The Effect of Light Level Applied During Breastfeeding on... | NCT06504823

Studies
The Effect of Light Level Applied During Breastfeeding on Maternal Stress, Anxiety, Psychological Well-being and Breastfeeding Motivation

NCT06504823

Sponsor

Emine Yıldırım

Status

Not yet recruiting

Last Update Posted

Jul 17, 2024Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Stress
Anxiety

Interventions

Light level

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 22, 2024Estimated

Primary Completion Date

Jul 26, 2024Estimated

Completion Date

Aug 2, 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 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.

Detailed Description

Not provided

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 level
experimental group	Experimental		Other: Light level

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Light level	Other	light application	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 of age or older, volunteering.

Exclusion Criteria:

Having any problem that prevents communication

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

ID	Term
D001008	Anxiety Disorders

ID	Term
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D028022	Low-Level Light Therapy

Ancestor Terms

ID	Term
D053685	Laser Therapy
D013812	Therapeutics
D010789	Phototherapy

Browse Leaves

Not provided

Browse Branches

Not provided