NCT05829538

Brief Summary

A single-blind randomized controlled study was conducted with female students studying at a foundation university. Women who met the sample selection criteria were randomized into three groups, 40 women in each group, a total of 120 women: Su Jok (A), Massage (B), and Control Group (C). Data were obtained by applying the Data Collection Form, the Visual Analogue Scale (VAS), the Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale, and the SF-36 Quality of Life Scale to the women followed for three menstrual cycles.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

March 31, 2023

Last Update Submit

April 13, 2023

Conditions

Keywords

Su JokMassagePrimary DismenoreaPain

Outcome Measures

Primary Outcomes (2)

  • Menstrual Pain VAS

    The effect of the intervention on menstrual pain was measured by VAS

    12 Weeks

  • Affected by dysmenorrhea

    Measured with the Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale

    12 Weeks

Study Arms (3)

Su Jok

EXPERIMENTAL

Su Jok Experimental Group (A): In this study, the seed therapy technique was applied using live buckwheat seeds. Hands were used because it was reported in the literature that hands were used for gynecological pain and were more suitable (Şimşek and Alpar, 2022). The acupuncture point, which is the reflection of the painful area, was determined on the women's hands. This point was massaged for a few minutes by the researcher, and then the buckwheat seed was fixed to this point with a bandage and the area where the seed was applied was massaged for 30 minutes. After each application, VAS evaluation was taken from the women. Su Jok was applied to women in the first three days of menstruation for three cycles.

Behavioral: SuJok

Massage

EXPERIMENTAL

Experimental Group (B) classical massage techniques (eufluorage, petrissage, friction, tapotman, vibration) was used. Massage was attempted for a total of 20 minutes, 10 minutes on the back and waist, and 10 minutes on the abdominal region, in the first three days of the three cycles. Massage application was started from the back and waist region. Efflorage, petrissage, friction, vibration, taputman and efflorage for one minute were applied to this area, respectively. Afterwards, three minutes of efflorage, petrissage, friction, and one-minute efflorage were applied to the abdominal region, respectively. Odorless, lubricating gel was used during the application. After each application, VAS evaluation was taken from the women. The women were massaged in the first three days of menstruation for three cycles.

Behavioral: Massage

Control

NO INTERVENTION

VAS evaluation was taken on the first three days during three cycles.

Interventions

SuJokBEHAVIORAL

Data were obtained by applying the Su Jok Efficiency Visual Analog Scale (VAS), Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale, and SF-36 Quality of Life Scale.

Su Jok
MassageBEHAVIORAL

Data were obtained by applying the Su Jok Efficiency Visual Analog Scale (VAS), Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale, and SF-36 Quality of Life Scale

Massage

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen with painful menstruation
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Not diagnosed with chronic and mental illness,
  • Not using hormonal contraceptives and analgesics,
  • Not having a pregnancy history, d) having regular menstrual cycles in the last 6 months (bleeding between 3-8 days and 21-35 days)
  • Verbal Women who stated that they had dysmenorrhea
  • years old g) Women who defined menstrual pain as 5 or higher according to the Visual Analogue Scale (VAS) were included.

You may not qualify if:

  • Dysmenorrhea and a gynecological diagnosis,
  • Regular exercise, massage and Su Jok practices were not included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Fatih, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In the study, the women were blind to each other in terms of practice and the data evaluator was blinded to the groups in the study in terms of analysis and reporting. Su Jok and massage application and follow-up were carried out by the researcher (FŞB), who could not be blinded to the applications. Randomization was done by another researcher (ZN). In order to avoid bias, the investigator (FSB) did not participate in any step of the pre-test, post-test and statistical evaluation process.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single Blind Randomized Controled Trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 25, 2023

Study Start

December 30, 2022

Primary Completion

March 30, 2023

Study Completion

August 30, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Data Collection: 4 Months Analysis: 3 Months Reporting and Publication 4 Months

Locations