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Active, not recruitingNCT06786481Updated Jan 22, 2025

Effect of Foot Massage Performed to the Mother After Bırth on Breastfeedıng Success, Sleep Qualıty and Newborn Stress

An interventional study of Educational with milnacipran and Locally Directed Therapy in Postpartum Women, sponsored by Melek Nur KEÇELİ. Active, not recruiting at 1 site in Turkey. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by Melek Nur KEÇELİ · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Sex
Female
01

Study 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.

Read the detailed description

: 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.

In the first stage, the researcher participants were informed about the purpose of the researcher and the questionnaire, and their consent was obtained for participation in the study.

In the second stage, Before starting the foot massage, the client will be informed about the number of sessions, their duration, and when they will be held. The average interview time for 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 birth when the woman feels well. Before the application, the researcher washes and dries her hands, and massages them with baby oil to warm them up properly and facilitate the process. First, a three-minute general massage is given to prepare the feet, and then the correct points are massaged for 10 minutes for each foot. The "Introductory Information Form", "LATCH Breastfeeding Diagnostic Measurement Tool", "Neonatal Stress Scale", and "Pittsburgh Sleep Quality Index (PSQI)" forms related to the study will be filled out. The woman's address and telephone information will be obtained in order to meet again.

02

Conditions studied

  • Postpartum Women

Keywords

  • reflexology massage, breastfeeding success, sleep quality, newborn stress
03

In context

Lead sponsor

This is the only study on the registry with Melek Nur KEÇELİ as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • 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 milnacipran · Behavioral: Locally Directed Therapy

Interventions

  • BehavioralEducational with milnacipran

    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.

  • BehavioralLocally Directed Therapy

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 day

  2. 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.

    Time frame: 30 day

07

Study locations

1 site
  • Melek Nur Keçeli
    Kahramanmaraş, 46100, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06786481
Lead sponsor
Melek Nur KEÇELİ
Responsible party
Melek Nur KEÇELİ (Principal Investigator, Kahramanmaras Sutcu Imam University) — Sponsor-investigator
First posted
Jan 22, 2025
Start date
Jan 1, 2025
Primary completion
Jul 30, 2025 (estimated)
Completion
Aug 30, 2025 (estimated)
Last update
Jan 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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