Postpartum WomenNCT06786481
Effect of Foot Massage Performed to the Mother After Bırth on Breastfeedıng Success, Sleep Qualıty and Newborn Stress
A study testing Educational with milnacipran and Locally Directed Therapy in people with Postpartum Women, run by Melek Nur KEÇELİ at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Women
- What is being tested?
- Educational with milnacipran and Locally Directed Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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,
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- Low-risk singleton pregnancy,
- Good foot health (cuts, burns, fungus, warts, etc.)
- No sensitivity to touch or massage.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Foot Massage Performed to the Mother After Post-Bırth on Breastfeedıng Success, Sleep Qualıty and Neonatal Stress: a Randomızed Controlled Study
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.
- Conditions
- Postpartum Women
- Being tested
- Educational with milnacipran, Locally Directed Therapy
- Keywords
- reflexology massage, breastfeeding success, sleep quality, newborn stress
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational with milnacipranBehavioural
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.
Locally Directed TherapyBehavioural
Also called kortizol, massage, breastfeeding
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Educational with milnacipran; Behavioral: Locally Directed Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Jan 2025
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Parallel asigment
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melek Nur KEÇELİ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melek Nur KEÇELİ, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786481
- Sponsor's protocol ID
- KahramanmaraşSIUA
- Status last verified
- Jan 2025
- First submitted
- 26 Sep 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keceli MN, Oztas HG. The Effects of Postpartum Foot Massage on Maternal Breastfeeding Success, Sleep Quality, and Newborn Stress: A Randomized Controlled Trial. Breastfeed Med. 2026 Sep;21(9):513-524. doi: 10.1177/15568253261457845. Epub 2026 Jun 23.
PubMed 42337997
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Massage Performed to the Mother After Post-Bırth on Breastfeedıng Success, Sleep Qualıty and Neonatal Stress: a Randomızed Controlled Study
- ClinicalTrials.gov ID
- NCT06786481
- Acronym / sponsor ID
- KahramanmaraşSIUA
- Conditions
- Postpartum Women
- Keywords
- reflexology massage, breastfeeding success, sleep quality, newborn stress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Melek Nur KEÇELİUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Parallel asigment
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Educational with milnacipran, Behavioral: Locally Directed TherapyBefore 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Literate,
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational with milnacipranBefore 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. | Behavioural | Experimental |
| Locally Directed TherapyAlso: kortizol, massage, breastfeedingBefore 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. | Behavioural | Experimental |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Derived from this study: PubMed 42337997Keceli MN, Oztas HG. The Effects of Postpartum Foot Massage on Maternal Breastfeeding Success, Sleep Quality, and Newborn Stress: A Randomized Controlled Trial. Breastfeed Med. 2026 Sep;21(9):513-524. doi: 10.1177/15568253261457845. Epub 2026 Jun 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational with milnacipran and Locally Directed Therapy in people with Postpartum Women, run by Melek Nur KEÇELİ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LATCH (time frame: 30 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06786481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.