Gynecologic NursingSuJok MassageNCT05829538
SuJok Massage Dismenorea Painful Menstruation
A study testing SuJok and Massage in people with Gynecologic Nursing, run by Halic University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Nursing
- What is being tested?
- SuJok and Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2022to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Dysmenorrhea and a gynecological diagnosis,
- Regular exercise, massage and Su Jok practices were not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sujok and Massage on Pain and Quality of Life in Women With Primary Dysmenorrhea: A Single-Blind, Randomized Controlled Study
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.
Read the 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.
- Conditions
- Gynecologic Nursing
- Being tested
- SuJok, Massage
- Keywords
- Su Jok, Massage, Primary Dismenorea, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuJokBehavioural
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.
MassageBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Massage |
| Control | No intervention | VAS evaluation was taken on the first three days during three cycles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual Pain VAS
The effect of the intervention on menstrual pain was measured by VAS
Measured: 12 Weeks
Affected by dysmenorrhea
Measured with the Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start30 Dec 2022
- Primary completion30 Mar 2023
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic NursingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Blind Randomized Controled Trials
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Collaborators
- Tülay Yılmaz, Hüsniye Dinç Kaya, Sevil Günaydın, Zülfiyye Nuraliyeva
- Responsible party
- Principal investigator, Fatma Şule Bilgiç, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829538
- Sponsor's protocol ID
- SuJok
- Acronym
- SuJok Massage
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data Collection: 4 Months Analysis: 3 Months Reporting and Publication 4 Months
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sujok and Massage on Pain and Quality of Life in Women With Primary Dysmenorrhea: A Single-Blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05829538
- Acronym / sponsor ID
- SuJok Massage / SuJok
- Conditions
- Gynecologic Nursing
- Keywords
- Su Jok, Massage, Primary Dismenorea, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Collaborators
- Tülay Yılmaz, Hüsniye Dinç Kaya, Sevil Günaydın, Zülfiyye Nuraliyeva
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single Blind Randomized Controled Trials
| Arm | Type | Receives |
|---|---|---|
| Su Jok | Experimental | Behavioral: SuJokSu 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. |
| Massage | Experimental | Behavioral: MassageExperimental 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. |
| Control | No intervention | –VAS evaluation was taken on the first three days during three cycles. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Dysmenorrhea and a gynecological diagnosis,
- Regular exercise, massage and Su Jok practices were not included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuJokData 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. | Behavioural | Su Jok |
| MassageData 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 | Behavioural | Massage |
Primary outcome
Menstrual Pain VAS
Time frame: 12 Weeks
The effect of the intervention on menstrual pain was measured by VAS
Affected by dysmenorrhea
Time frame: 12 Weeks
Measured with the Functional and Emotional Dysmenorrhea (Painful Menstruation) Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No. Data Collection: 4 Months Analysis: 3 Months Reporting and Publication 4 Months
Related trials for Gynecologic Nursing
Not yet recruiting
Effects of a Self-Regulation Based E-MOTE Program Delivered Via an AI-Assisted Robot and Supported by Mobile Platforms for Newly Diagnosed Gynecologic Cancer Patients
Nursing, Gynecological Cancers
Recruiting
Emotional Assessment and Tiered Individualized Psychological Support of the Artificial Intelligence Robot
Emotional Assessment, Nursing
Recruiting
The Effect of Mobile-Based Education Given to Patients Undergoing Gynecological Oncology Surgery on Quality of Life
Gynecologic Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SuJok and Massage in people with Gynecologic Nursing, run by Halic University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual Pain VAS (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.