Effect of Su Jok Therapy on Breastfeeding (Sujok)

October 9, 2024 updated by: Aysegul Kilicli

The Effect of Su Jok Therapy on Breastfeeding Success, Breastfeeding Self-Efficacy and Perception of Insufficient Milk After Caesarean Section in Primiparas

There are many alternative methods to increase breast milk. In the literature, studies on Su Jok therapy applications are limited and no studies on increasing breast milk have been found. In Korean language, 'Su' means hand and 'Jok' means foot. Su Jok therapy is defined as a modern acupressure/acupuncture interpretation that utilises the body's independent communication systems on the hands and feet by applying various techniques such as massage, moxa (heating), needles, magnets and seeds to the reflection points on the hands and feet. Su Jok is an integrated therapy that incorporates many tried and trusted methods of oriental medicine

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are many alternative methods to increase breast milk. In the literature, studies on Su Jok therapy applications are limited and no studies on increasing breast milk have been found. In Korean language, 'Su' means hand and 'Jok' means foot. Su Jok therapy is defined as a modern acupressure/acupuncture interpretation that utilises the body's independent communication systems on the hands and feet by applying various techniques such as massage, moxa (heating), needles, magnets and seeds to the reflection points on the hands and feet. Su Jok is an integrated therapy that incorporates many tried and trusted methods of oriental medicine.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Eyalet/Yerleşke
      • Şanlıurfa, Eyalet/Yerleşke, Turkey, 63000
        • Recruiting
        • Sanlıurfa Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • primiparous women giving birth by caesarean section,
  • women aged 19-35,
  • breastfeeding women

Exclusion Criteria:

  • those who refused to participate in the research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control group
control group, Su Jok will not be applied
Experimental: su jok therapy;
su jok therapy; application of seeds placed at certain points on the palm of the hand every day for the first ten days after birth, every day to be kept in the hand for 2 hours.
Behavioral: Su Jok Therapy
Su Jok Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Inadequate Milk Perception Scale
Time Frame: pre-test
The scale developed by McCarter-Spaulding and Kearney in 2001 consists of 6 questions to determine inadequate perception of breast milk. The first question questioning whether the mother perceives her milk as sufficient or not is in the form of 'yes' or 'no'. The other 5 questions aim to measure the perception of inadequacy of milk and are scored between 0-10. '0' indicates that milk is perceived as completely inadequate and "10" indicates that milk is perceived as completely adequate. The scale is scored between 0-50. A high score indicates an increased perception of milk sufficiency.
pre-test
Inadequate Milk Perception Scale
Time Frame: 3rd day after caesarean section
The scale developed by McCarter-Spaulding and Kearney in 2001 consists of 6 questions to determine inadequate perception of breast milk. The first question questioning whether the mother perceives her milk as sufficient or not is in the form of 'yes' or 'no'. The other 5 questions aim to measure the perception of inadequacy of milk and are scored between 0-10. '0' indicates that milk is perceived as completely inadequate and "10" indicates that milk is perceived as completely adequate. The scale is scored between 0-50. A high score indicates an increased perception of milk sufficiency.
3rd day after caesarean section
Inadequate Milk Perception Scale
Time Frame: 10th day after caesarean section
The scale developed by McCarter-Spaulding and Kearney in 2001 consists of 6 questions to determine inadequate perception of breast milk. The first question questioning whether the mother perceives her milk as sufficient or not is in the form of 'yes' or 'no'. The other 5 questions aim to measure the perception of inadequacy of milk and are scored between 0-10. '0' indicates that milk is perceived as completely inadequate and "10" indicates that milk is perceived as completely adequate. The scale is scored between 0-50. A high score indicates an increased perception of milk sufficiency.
10th day after caesarean section
Breastfeeding Self-Efficacy Scale
Time Frame: pre-test
It was developed by Dennis (2003). Its Turkish validity and reliability was conducted by Aluş Tokat et al. (2010). The scale consists of 14 items and is in five-point Likert type. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
pre-test
Breastfeeding Self-Efficacy Scale
Time Frame: 3rd day after caesarean section
It was developed by Dennis (2003). Its Turkish validity and reliability was conducted by Aluş Tokat et al. (2010). The scale consists of 14 items and is in five-point Likert type. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
3rd day after caesarean section
Breastfeeding Self-Efficacy Scale
Time Frame: 10th day after caesarean section
It was developed by Dennis (2003). Its Turkish validity and reliability was conducted by Aluş Tokat et al. (2010). The scale consists of 14 items and is in five-point Likert type. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. A minimum of 14 points and a maximum of 70 points can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
10th day after caesarean section
Breastfeeding Charting System: LATCH
Time Frame: pre-test
It was developed by Jensen et al. (1994). Its Turkish validity and reliability was performed by Yenal and Okumuş (2003). LATCH includes five evaluation criteria and consists of the first letters of the English equivalents of these criteria. In the LATCH Scoring System, 0, 1 or 2 points are given for each criterion A minimum score of 0 and a maximum score of 10 can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
pre-test
Breastfeeding Charting System: LATCH
Time Frame: 3rd day after caesarean section
It was developed by Jensen et al. (1994). Its Turkish validity and reliability was performed by Yenal and Okumuş (2003). LATCH includes five evaluation criteria and consists of the first letters of the English equivalents of these criteria. In the LATCH Scoring System, 0, 1 or 2 points are given for each criterion. A minimum score of 0 and a maximum score of 10 can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
3rd day after caesarean section
Breastfeeding Charting System: LATCH
Time Frame: 10th day after caesarean section
It was developed by Jensen et al. (1994). Its Turkish validity and reliability was performed by Yenal and Okumuş (2003). LATCH includes five evaluation criteria and consists of the first letters of the English equivalents of these criteria. In the LATCH Scoring System, 0, 1 or 2 points are given for each criterion. A minimum score of 0 and a maximum score of 10 can be obtained from the scale. All items are positive. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.
10th day after caesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aysegul Kilicli

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: AYŞEGÜL KILIÇLI, Assisstan. Prof. PhD., Muş Alparslan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MAUN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All

IPD Sharing Time Frame

15 October 2024- 15 October 2025

IPD Sharing Access Criteria

15 October 2024- 15 October 2025

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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