- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07544511
Effect of Hand Massage Stimulation on Pain and Menstrual Symptoms in Primary Dysmenorrhea
Purpose of this study: The purpose of this study is to determine the effect of hand massage stimulation techniques on pain, daily menstrual symptoms and nausea and vomiting in primary dysmenorrhea.
H1a: Hand massage stimulation techniques reduce pain in primary dysmenorrhea. H1b: Hand massage stimulation techniques reduce daily menstrual symptoms in primary dysmenorrhea.
The data were collected from students suffering from primary dysmenorrhea pain studying at İnönü University Faculty of Health Sciences. Seed therapy (su-jok) will be applied by researcher Esra Tan, who has a basic level su-jok therapy certificate.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to determine the effect of hand massage stimulation techniques on pain, daily menstrual symptoms and nausea and vomiting in primary dysmenorrhea.
Data will be collected from students experiencing Primary Dysmenorrhea at İnönü University Faculty of Health Sciences. Participants who meet the inclusion criteria and agree to participate will be informed about the study, and participants who fill out the "Minimum Informed Consent Form" will be included in the study. Data collection forms will be applied by the researcher, paying attention to student privacy, and the pre-test data collection phase will be completed. After the pre-test data collection phase is completed, hand stimulation techniques (su-jok seed therapy) will be applied by the researcher to the students experiencing primary dysmenorrhea in the experimental group. Students experiencing primary dysmenorrhea will be given detailed information about the application in the laboratory at the faculty, and pain points will be determined according to the reflections of the organs on the hand. Black pepper seeds, one of the seeds used in the treatment of primary dysmenorrhea, will be placed on the detected points and removed after 5-6 hours. This application will be done a total of 3 times in each cycle, on the 1st, 2nd and 3rd day of the menstrual cycle. A total of 2 cycles of application will be made, the first menstrual cycle being the 1st cycle, and the final test data will be collected 5-6 hours after each application. This intervention will be carried out by Melike Tan, and the researcher has a basic level Su Jok therapy certificate. No intervention will be applied to the students experiencing primary dysmenorrhea in the control group, but the Personal Information Form, Visual Analog Scale (VAS), and Daily Menstrual Symptom Assessment Scale (GMDSS) will be administered simultaneously to the experimental group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Malatya, Turkey (Türkiye)
- İnönü University Faculty of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participant who is 18 years or older
- Participant diagnosed with primary dysmenorrhea by a gynecologist
- Participant who has had regular menstruation in the last 6 months
- Participant whose menstrual pain continues for 8-72 hours
Exclusion Criteria:
- Participant who is pregnant
- Participant who has given birth before or has a history of pregnancy
- Participant using intrauterine or oral contraceptives
- Participant who is taking any anti-inflammatory, analgesic and psychotherapeutic medication
- Participant with any history of pelvic pathology or pelvic surgery
- Participant with any neurological or systemic disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: seed therapy ( su-jok)
Group that received seed therapy ( su- jok )
|
In hand massage, tiny swellings called "ball conformity" occur on the reflection points of the organs where the complaint occurs on the hands and feet.
It is argued that the sensitivity of the relevant point to pressure has a direct correlation with the level of pain in the body part.
A rod called a "diagnostic probe" or "diagnostic rod" made of metal, plastic or wood, approximately ten centimeters long, is used to detect the painful point on the hand and foot.
After the correct point is detected, various techniques are applied to stimulate these points and ensure the continuation of the energy flow.In this study, the seed massage technique, which does not cause any side effects among the hand massage stimulation methods, requires a basic level certificate for its use, does not require being a health professional, and can be easily applied by anyone, will be used.
Seed massage is a method applied by first detecting pain through a probe on the points of the organs reflected on the hand
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No Intervention: standard maintenance
group not receiving seed therapy ( su- jok)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: At baseline (pre-intervention) and immediately after completion of seed therapy]
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Description: VAS is a scale created in the range of 0-10 cm. According to the scale, 0 cm means the pain is not severe at all, and 10 cm means unbearable pain. On the scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, and 75-100 mm indicates severe pain. Time Frame: At baseline (pre-intervention) and immediately after completion of seed therapy. |
At baseline (pre-intervention) and immediately after completion of seed therapy]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily Menstrual Symptom Assessment Scale (DMSA)
Time Frame: At baseline (pre-intervention) and immediately after completion of seed therapy]
|
The GMMSS was developed by Taylor in 1979 to assess symptoms and their severity during menstruation. The Turkish validity and reliability of the scale were established by Oskay et al. in 2008. The scale consists of seventeen items, with each symptom severity scored between 0 and 5, and there are no subscales. An increase in the score indicates an increase in symptom severity. In Oskay et al.'s study, the Cronbach's alpha value of the scale was found to be 0.88. [Time Frame: Initially (before intervention) and immediately after completion of insemination treatment] |
At baseline (pre-intervention) and immediately after completion of seed therapy]
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Esra GÜNEY, PhD, Inonu University
Publications and helpful links
Helpful Links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7879
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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