- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06786481
Effect of Foot Massage Performed to the Mother After Bırth on Breastfeedıng Success, Sleep Qualıty and Newborn Stress
Effect of Foot Massage Performed to the Mother After Post-Bırth on Breastfeedıng Success, Sleep Qualıty and Neonatal Stress: a Randomızed Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kahramanmaraş, Turkey, 46100
- Melek Nur Keçeli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LATCH
Time Frame: 30 day
|
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
Time Frame: 30 day
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Serotonin and Noradrenaline Reuptake Inhibitors
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Sensory System Agents
- Analgesics, Non-Narcotic
- Analgesics
- Neurotransmitter Agents
- Membrane Transport Modulators
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Antidepressive Agents
- Milnacipran
- Levomilnacipran
Other Study ID Numbers
- KahramanmaraşSIUA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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