- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05829538
SuJok Massage Dismenorea Painful Menstruation (SuJok Massage)
The Effect of Sujok and Massage on Pain and Quality of Life in Women With Primary Dysmenorrhea: A Single-Blind, Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study was performed in a single-blind, randomized controlled type to examine the effect of Su Jok and massage on pain and quality of life in women with primary dysmenorrhea.The sample size in this study was G*Power 3.1.9.2. In the program, 5% first type error, 0.30 standardized effect size, 1:1 distribution ratio, 80% power, and the minimum sample size required for the three groups were calculated as 111 women and 37 women for each group. Considering that there may be losses, 40 women and a total of 120 women were randomized to each group.
"Data Collection Form", "Visiual Analog Scale (VAS)", "Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale", "SF-36, Quality of Life Scale" were used to obtain data.Intervention and Data Collection Stage 1: VAS was applied to the women who volunteered to participate in the study on the first day of menstruation, and women with a mean score of 5 and above and meeting the sample selection criteria were randomized into three separate groups as A, B, and C. The researcher who performed the randomization ensured that the women were assigned to the control and experimental groups and did not share this information with the other researchers. Data Collection Form, Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale, SF-36 Quality of Life Scale were applied to all women on the first day of the next menstruation. Since the data collection tools were based on self-report, the woman was allowed to answer in a calm environment and alone. The environment where the applications will be held was arranged in such a way that the researcher and the participant could sit opposite each other with two chairs and an application table. Entry and exit to the room was prevented until the application was over. The environment was quiet.
Stage 2 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.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.Experimental Group (B) to whom massage was applied: Massage application determined by scanning the literature and taking expert opinion 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. Massage was applied to the women in the first three days of menstruation for three cycles.
Control Group (C): VAS assessment was obtained for the first three days during three cycles.
Stage 3 Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale and SF-36 Quality of Life Scale were applied to all women included in the study on the third day of the third cycle.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Fatih, Istanbul, Turkey
- Istanbul University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 18-35 years old g) Women who defined menstrual pain as 5 or higher according to the Visual Analogue Scale (VAS) were included.
Exclusion Criteria:
- Dysmenorrhea and a gynecological diagnosis,
- Regular exercise, massage and Su Jok practices were not included.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Su Jok
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.
|
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.
|
|
Experimental: Massage
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.
|
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
|
|
No Intervention: Control
VAS evaluation was taken on the first three days during three cycles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Menstrual Pain VAS
Time Frame: 12 Weeks
|
The effect of the intervention on menstrual pain was measured by VAS
|
12 Weeks
|
|
Affected by dysmenorrhea
Time Frame: 12 Weeks
|
Measured with the Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale
|
12 Weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
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
Other Study ID Numbers
- SuJok
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
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