- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06760013
The Effect of Su-jok Therapy Applied in the First Stage of Labor on Pain Level in Primiparas
Study Overview
Detailed Description
Birth pain, known as acute pain, is felt in the human body as one of the oldest, complex, severe and most difficult to control types of pain. However, this pain differs from other types of pain due to the fact that it reunites the mother with her baby and covers a limited period of time. Pain is a subjective phenomenon that every individual experiences throughout their lives and to which people react differently.
Su Jok therapy, an alternative and complementary therapy technique, is seen as a method that balances the energy flow based on the philosophy of non-pharmacological and non-invasive acupuncture that can be used to control labor pain.
Su-jok application is the development of a massage therapy that will create a feeling of comfort in the body by using certain points. There are tiny swellings on the reflection points on the hands and feet (such as the area between the 3rd and 4th fingers reflecting the uterus area). These are also called micro acupuncture points. When pressure is applied to these swellings on the hands and feet for 1-2 minutes, pain and a feeling of pulling occur. Thus, the area to be massaged is determined. During the detection phase, a blunt-tipped diagnostic probe or a round-tipped stick can be used. At this stage, the same amount of pressure should be applied to the area to be applied. When a point is determined, the correct point for massage application should be massaged and energy flow should be provided. Since it does not have any side effects, it is a therapy that can be used in pregnant women and is a massage application that does not require any invasive intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: AYSUDA R AKVERAN
- Phone Number: +90 534-610-2318
- Email: Aysuda.2375@gmail.com
Study Locations
-
-
Merkez
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Çorum, Merkez, Turkey, 19000
- Hitit university
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Contact:
- AYSUDA R AKVERAN
- Phone Number: +90 534-610-2318
- Email: Aysuda.2375@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being primiparous
- The pregnant woman must be over 18 years of age
- To participate in the research voluntarily
- The beginning of labor (water breaking, presence of non-stress testa contractions, engagement)
Exclusion Criteria:
- Pregnancies outside 37-41 weeks
- Multiparas
- Those who are not pregnant
- Having visual, mental and auditory disabilities
- Being pregnant as an adolescent
- Not accepting participation in the research
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Su jok therapy group
Sujok massage therapy will be applied to the affected area on the hands of pregnant women who will give birth for the first time.
|
The researcher, who has a Su-Jok practitioner certificate, applied pressure for 1-2 minutes on the active point on the meridian (the area between the 3rd and 4th fingers pointing to the uterus) that provides energy flow in the palm in 20-minute periods, with the help of a diagnostic probe (diagnostic stick).
The point will be determined.
Once this point is detected, a massage will be performed on the point.
The massage will be applied with a 10-minute rest period between each two periods.
|
|
No Intervention: Control Group
A comparison will be made on this group with pregnant women who receive sujok therapy without any therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: eight months
|
A number indicating the pain level will be expressed on the scale between 1-10.
|
eight months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MONITORING FORM FOR BIRTH (FOR SU JOK GROUP)
Time Frame: eight months
|
It is a survey that includes pregnant women's information about birth and their opinions on su jok therapy.
|
eight months
|
|
MONITORING FORM FOR BIRTH (CONTROL GROUP)
Time Frame: eight months
|
The survey, which consists of nine questions, includes information about the birth process of pregnant women.
(Vitals, vaginal examination findings)
|
eight months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HU-SBF-ARA-01
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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