NCT06983600

Brief Summary

Menarche, which is one of the most prominent features of maturation in adolescents and the transition from childhood to adulthood, causes many problems. The most prominent of these complaints is dysmenorrhea. Primary dysmenorrhea, the most common form of dysmenorrhea, is a gynecological disorder characterized by pain that starts in the lower abdomen before or during menstruation and radiates to the waist and legs. Primary dysmenorrhea is seen especially in women under 25 years of age and within 6-12 months after menarche. Dysmenorrhea is a preventable and treatable disease. There are pharmacologic and nonpharmacologic methods in the treatment of dysmenorrhea. Pharmacologic methods include NSAIDs and hormonal contraceptives. Nonpharmacological methods used in the treatment of dysmenorrhea include hot application, regulation of nutrition, relaxation exercises, massage, yoga, reflexology, acupuncture, acupressure, TENS method, vitamins B and E, calcium, magnesium, zinc supplements, fennel and rose teas, ginger, aromotherapy applications. In addition to pharmacological methods, nonpharmacological methods are frequently used in the treatment of dysmeorrhea. People have recently turned to alternative medicine in the treatment of diseases in order to get rid of the side effects of drugs. Today, medicine is constantly developing and new treatment options are emerging. The treatment method that has recently started to be used and its effect has been seen is SuJok therapy. SuJok therapy was developed in 1986 by South Korean scientist Professor Park Jae Woo. In Korean, "Su" means hand and "Jok" means foot. In SuJok therapy, hands and feet are used as a treatment method. In SuJok, the hands and feet are a miniature replica of the body and have maximum structural similarity to the human body in anatomical terms. Every organ in our body has reflection points on the hands and feet. Thus, it activates all organs in our body with hands and feet. With the SuJok therapy method, it is argued that by using various techniques with the reflections of the body in the hand and foot points of the body, the organ and body area are physically stimulated and the energy in the body is activated and healing occurs. In the literature, studies on SuJok therapy applications are limited and there are no studies showing the effect of SuJok application on primary dysmenorrhea.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

March 17, 2026

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

April 3, 2025

Last Update Submit

March 15, 2026

Conditions

Keywords

alternative treatmentprimary dysmenorrhea, quality of life

Outcome Measures

Primary Outcomes (3)

  • Pre and Post Intervention Dysmenorrhea Follow-up Form

    1\. In the first part, the premenstrual dysmenorrhea follow-up form is applied. The pain felt in the form is evaluated using the Visual Analog Scale (VAS). 0-10; 0- No pain, 10- Worst pain.

    Pain intensity reported at baseline, day 1 and day 10 of menstruation after intervention

  • World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF)

    WHOQOL-BREF is a valid and reliable scale developed by the World Health Organization to assess health-related quality of life. The short form of the scale includes 27 questions. These questions give physical, mental, social and environmental scores. The score that each area can get independently of each other is between 4-20. The increase in the score indicates an increase in quality of life.

    Pain intensity reported at baseline, day 1 and day 10 of menstruation after intervention

  • Dysmenorrhea Follow-up Form after Sujok therapy application

    After the su jok therapy applied during menstruation, a dysmenorrhea follow-up form is applied. The pain felt in the form is evaluated using the Visual Analog Scale (VAS). 0-10; 0- No pain, 10- The worst pain.

    Pain intensity reported at baseline, day 1 and day 10 of menstruation after intervention

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The female students in the study group will be pre-tested by the researcher during the 1st menstrual period before the application. Then, starting from the 1st day of the 2nd month menstrual period for a total of 10 days, the points will be sensitized and the painful point will be detected by the researcher with the macro bug in the hand and the ring in the mini system and the spiral in the hand. Then, moxa will be applied to the reflection point of the uterus and ovary for 2 minutes to 5 minutes. After the moxa application, the black pepper seed will be fixed to the painful point with the help of an airtight plaster. The black pepper seed will be kept for at least 4 hours and maximum 8-10 hours.

Other: alternative therapy:sujok therapy

Control Arm

NO INTERVENTION

In the control group, no application was made during and after the menstrual period.

Interventions

As of the first day of the menstrual period for a total of 10 days, the researcher will provide sensitization of the points and painful point detection with the ring and in-hand spiral in the hand macro insect and mini system. Then, moxa will be applied to the uterus and ovary reflection point between 2 minutes and 5 minutes. Moxa is a method that burns wormwood and treats it with the heat emitted to the skin by the smoke with perforated apparatus. It is one of the oldest treatment methods based on heat and plant healing. After the Moxa application, the black pepper seed will be fixed to the painful spot with the help of an air-tight plaster. The black pepper seed will be kept for at least 4 hours and maximum 8-10 hours.

Intervention Arm

Eligibility Criteria

Age18 Months - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Scoring menstrual pain 5 and above out of 10 points on the VAS Visual Pain Scale,
  • Don't be nullipar,
  • Regular mentruation for at least the last six months,
  • Not having any gynecological diagnosis,
  • Not having undergone any gynecological operation,
  • Willingness and acceptance to participate in the study,
  • In addition, students who do not have any lesions, infections, etc. that prevent the application of water jok therapy on the hands and feet

You may not qualify if:

  • \- Scoring 4 or less out of 10 points on the VAS Visual Pain Scale,
  • Participants who volunteered to participate in the study and wanted to leave at any stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Merkez, 27010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

April 3, 2025

First Posted

May 21, 2025

Study Start

January 30, 2025

Primary Completion

August 30, 2025

Study Completion

August 30, 2025

Last Updated

March 17, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

It was planned to share basic information such as the age, education level, place of residence, smoking status, height-weight ratio, knowledge about menstruation, how long menstrual pain lasts, whether there is a relative in the family who has pain during menstruation, whether they use painkillers, if so, who recommended them, whether they do anything other than painkillers to relieve menstrual pain, and if so, what they are, whether your menstrual pain affects your daily activities and school attendance. Basic comparison results with the World Health Organization Quality of Life Scale-Short Form (WHOQOL-BREF) and Visual Assessment Scale (VAS) scales will be shared.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
The study is planned to be finalized from April 2025 to September 2025. the translation of the results into an article is planned to be done until December 2025.
Access Criteria
For variables with two groups, the independent groups t-test and the non-parametric Mann Whitney U test, and for variables with at least three or more groups, the one-way analysis of variance and the non-parametric Kruskall Wallis H test were considered. In the analysis of the differences and changes between two measurements over time in groups, the t-test was used in dependent groups in groups that met the assumption of normal distribution, and the Wilcoxon signed-rank test was used in groups that did not meet the assumption of normal distribution. Again, in the analysis of the differences and changes between three or more measurements according to time in the groups, it was planned to use one-way analysis of variance in repeated measures in groups that meet the assumption of normal distribution, and Friedman test in groups that do not meet the assumption of normal distribution. Statistical significance level will be accepted as p\<0.05 in all tests.

Locations