NCT06786481

Brief Summary

Aim: To Reveal The Effect Of Foot Massage Performed To The Mother After Bırth On Breastfeedıng Success, Sleep Qualıty And Newborn Stress Material and Method: This randomized controlled trial was conducted with 70 people (35 experimental, 35 control) in a public hospital in Kahramanmaraş.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

September 26, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

September 26, 2024

Last Update Submit

January 21, 2025

Conditions

Keywords

reflexology massage, breastfeeding success, sleep quality, newborn stress

Outcome Measures

Primary Outcomes (2)

  • LATCH

    It was developed by Jensen and Wallace in 1994 in order to perform breastfeeding assessment objectively and systematically, to identify breastfeeding problems, to establish a common language among healthcare professionals and to be used in studies. It is similar to the apgar score system in terms of scoring method. This measurement tool consists of five assessment items. The word LATCH is a combination of the first letters of the English equivalents of these items.

    30 day

  • Neonatal Stress Scale

    The neonatal stress scale developed by Ceylan and Bolışık consists of a total of 24 items in 3-point Likert type. The scale items include 8 subgroups including facial expression, body colour, respiration, activity level, comfort, muscle tone, extremities and posture and each subgroup is evaluated between 0-2 points in scoring. A minimum score of 0 and a maximum score of 16 points are obtained from the scale. As the score increases, the stress level of the baby increases simultaneously.

    30 day

Study Arms (1)

Experimental

EXPERIMENTAL

Before starting the foot massage, the client is informed about the number, duration and time of the session. The average interview time with the patients in the experimental group will be 15-20 minutes. The first interview with the women in the experimental group will be held at any time after the birth when the woman feels well. Before the application, the researcher washes and dries her hands and warms them appropriately by massaging with baby oil and facilitates the process. First, a three-minute general massage is performed to prepare the feet, and then the correct points for each foot are massaged for 10 minutes. 'Introductory Information Form', "LATCH Breastfeeding Diagnostic Measurement Tool", "Newborn Stress Scale" and "Pittsburgh Sleep Quality Index (PSQI)" forms will be filled. The woman's address and telephone details will be taken to meet again.

Behavioral: Educational with milnacipranBehavioral: Locally Directed Therapy

Interventions

Before starting the foot massage, the client is informed about the number, duration and time of the session. The average interview time with the patients in the experimental group will be 15-20 minutes. The first interview with the women in the experimental group will be held at any time after the birth when the woman feels well. Before the application, the researcher washes and dries her hands and warms them appropriately by massaging with baby oil and facilitates the process. First, a three-minute general massage is performed to prepare the feet, and then the correct points for each foot are massaged for 10 minutes. 'Introductory Information Form', "LATCH Breastfeeding Diagnostic Measurement Tool", "Newborn Stress Scale" and "Pittsburgh Sleep Quality Index (PSQI)" forms will be filled. The woman's address and telephone details will be taken to meet again.

Experimental

Before starting the foot massage, the client is informed about the number, duration and time of the session. The average interview time with the patients in the experimental group will be 15-20 minutes. The first interview with the women in the experimental group will be held at any time after the birth when the woman feels well. Before the application, the researcher washes and dries her hands and warms them appropriately by massaging with baby oil and facilitates the process. First, a three-minute general massage is performed to prepare the feet, and then the correct points for each foot are massaged for 10 minutes. 'Introductory Information Form', "LATCH Breastfeeding Diagnostic Measurement Tool", "Newborn Stress Scale" and "Pittsburgh Sleep Quality Index (PSQI)" forms will be filled. The woman's address and telephone details will be taken to meet again.

Also known as: kortizol, massage, breastfeeding
Experimental

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Literate,
  • Communicative,
  • Poor sleep status (with a global score of ≧5 on the PSQI,
  • Patients who volunteer to participate in the study,
  • Minimum and maximum gestational age of 37 and 42 weeks,
  • No psychological disorder,
  • Low-risk singleton pregnancy,
  • Good foot health (cuts, burns, fungus, warts, etc.)
  • No sensitivity to touch or massage.

You may not qualify if:

  • Those who wish to withdraw from the study, • Patients with deficiencies or errors in any of the forms used to collect data will be removed from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melek Nur Keçeli

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

MilnacipranMassageLactation

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

CyclopropanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Parallel asigment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2024

First Posted

January 22, 2025

Study Start

January 1, 2025

Primary Completion

July 30, 2025

Study Completion

August 30, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations