Pregnancy RelatedNCT07389707
The Effect of Using Hand Massage Stimulation Techniques on Pain and Comfort in Pregnant Women Experiencing Lumbar Pain
A study testing seed therapy (su-jok) in people with Pregnancy Related, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effects of hand massage stimulation techniques applied to pregnant women with low back pain on pain and comfort. H1-a: Hand massage stimulation technique applied to pregnant women reduces low back pain. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- seed therapy (su-jok)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2024to 15 Jan 2025
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women who are over 18 years old,
- Able to read and write,
- Have back pain severity of 45 mm and above according to Visual Analogue Scale (VAS),
- Aren't experiencing risky pregnancies,
- Do not have any psychiatric disorders,
- Have a gestational age of 32 weeks or above,
- Do not react negatively to any interventions such as massage,
- Have healthy and complete tissue integrity in the area where the massage will be performed will be included in the sample.
Who cannot join
- Pregnant women with acute or chronic diseases, traumas, or surgical history related to the musculoskeletal or nervous system,
- Those who have gynecological or urological problems that cause pain during pregnancy (premature birth, pyelonephritis, etc.),
- Those who use analgesics during pregnancy,
- Those who have difficulty communicating and mentally ill,
- Those who have a condition that may prevent written or verbal communication,
- Those who have maternal and fetal complications in their current pregnancy will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the effects of hand massage stimulation techniques applied to pregnant women with low back pain on pain and comfort.
H1-a: Hand massage stimulation technique applied to pregnant women reduces low back pain.
H1-b: Hand massage stimulation technique applied to pregnant women increases comfort Data will be collected from pregnant women who apply to the NST polyclinic and complain of back pain. Midwifery intervention will be implemented in a way that does not disrupt the examination routine. Seed therapy (su-jok) will be applied by researcher Esra Tan, who has a basic level su jok therapy certificate.
Read the detailed description
The aim of this study is to determine the effects of hand massage stimulation techniques applied to pregnant women with low back pain on pain and comfort.
Data will be collected from pregnant women who apply to the NST polyclinic in the gynecology and obstetrics clinic of the Adıyaman Gölbaşı State Hospital and complain of back pain. 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 patient 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 to the pregnant women in the experimental group by the researcher. Pregnant women will be invited to the pregnancy education class in the relevant hospital and detailed information will be given about the application, and pain points will be determined according to the reflections of the organs on the hand. Buckwheat seeds, one of the seeds used for back pain, will be fixed on the detected points and the fixed seed will be removed after 5-6 hours. This application will be done in 1 session and the post-test will be applied 15 minutes after the seed is removed. This intervention will be implemented by Esra Tan and the researcher has a basic level su jok therapy certificate. No intervention will be applied to the pregnant women in the control group, however, the Personal Information Form, Visual Analog Scale (VAS), Prenatal Comfort Scale and Oswestry Disability Index will be applied simultaneously with the experimental group.
- Conditions
- Pregnancy Related
- Being tested
- seed therapy (su-jok)
- Keywords
- back pain, comfort, pregnant, massage, midwife
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seed therapy (su-jok)Other
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
| Study group | Role | What they receive |
|---|---|---|
| seed therapy ( su-jok) | Experimental | Group that received seed therapy ( su- jok ) Receives: Other: seed therapy (su-jok) |
| standard maintenance | No intervention | group not receiving seed therapy ( su- jok) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal Comfort Scale scores
The initial version of the scale consisted of 34 items, but was later revised by the authors and shortened to 15 items (21). The short version of the scale consists of 15 items and 5 sub-dimensions. Each item is scored between 0-5 (0=Strongly disagree, 1=Disagree, 2=Undecided, 3=Somewhat agree, 4=Agree, 5=Strongly agree). The scale is evaluated out of a total of 75 points.
Measured: At baseline (pre-intervention) and immediately after completion of seed therapy]
Secondary outcomes (1)
Oswestry Disability Index scores
It consists of 10 questions, each scored between 0 and 5, that examine the severity of pain, personal care, lifting, walking, sitting, standing, sleeping, social life, travel and the degree of change in pain in order to evaluate the effect of low back pain on daily activities. The quality of life increases as the score obtained from the Oswestry Disability Index decreases.
Measured: At baseline (pre-intervention) and immediately after completion of seed therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start15 Oct 2024
- Primary completion15 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment randomized controlled trial conducted with experimental and control groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Tan, Inonu University
- Investigators
- Esra GÜNEY, PhD, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389707
- Sponsor's protocol ID
- 2024/129
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Hand Massage Stimulation Techniques on Pain and Comfort in Pregnant Women Experiencing Lumbar Pain
- ClinicalTrials.gov ID
- NCT07389707
- Acronym / sponsor ID
- 2024/129
- Conditions
- Pregnancy Related
- Keywords
- back pain, comfort, pregnant, massage, midwife
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 5 Feb 2026 (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.
The aim of this study is to determine the effects of hand massage stimulation techniques applied to pregnant women with low back pain on pain and comfort.
H1-a: Hand massage stimulation technique applied to pregnant women reduces low back pain.
H1-b: Hand massage stimulation technique applied to pregnant women increases comfort Data will be collected from pregnant women who apply to the NST polyclinic and complain of back pain. Midwifery intervention will be implemented in a way that does not disrupt the examination routine. Seed therapy (su-jok) will be applied by researcher Esra Tan, who has a basic level su jok therapy certificate.
Detailed description
The aim of this study is to determine the effects of hand massage stimulation techniques applied to pregnant women with low back pain on pain and comfort.
Data will be collected from pregnant women who apply to the NST polyclinic in the gynecology and obstetrics clinic of the Adıyaman Gölbaşı State Hospital and complain of back pain. 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 patient 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 to the pregnant women in the experimental group by the researcher. Pregnant women will be invited to the pregnancy education class in the relevant hospital and detailed information will be given about the application, and pain points will be determined according to the reflections of the organs on the hand. Buckwheat seeds, one of the seeds used for back pain, will be fixed on the detected points and the fixed seed will be removed after 5-6 hours. This application will be done in 1 session and the post-test will be applied 15 minutes after the seed is removed. This intervention will be implemented by Esra Tan and the researcher has a basic level su jok therapy certificate. No intervention will be applied to the pregnant women in the control group, however, the Personal Information Form, Visual Analog Scale (VAS), Prenatal Comfort Scale and Oswestry Disability Index will be applied simultaneously with the experimental group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Crossover Assignment randomized controlled trial conducted with experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| seed therapy ( su-jok) | Experimental | Other: seed therapy (su-jok)Group that received seed therapy ( su- jok ) |
| standard maintenance | No intervention | –group not receiving seed therapy ( su- jok) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Pregnant women who are over 18 years old,
- Able to read and write,
- Have back pain severity of 45 mm and above according to Visual Analogue Scale (VAS),
- Aren't experiencing risky pregnancies,
- Do not have any psychiatric disorders,
Key exclusion criteria (6 listed)
- Pregnant women with acute or chronic diseases, traumas, or surgical history related to the musculoskeletal or nervous system,
- Those who have gynecological or urological problems that cause pain during pregnancy (premature birth, pyelonephritis, etc.),
- Those who use analgesics during pregnancy,
- Those who have difficulty communicating and mentally ill,
- Those who have a condition that may prevent written or verbal communication,
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 |
|---|---|---|
| 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 | Other | seed therapy ( su-jok) |
Primary outcome
Prenatal Comfort Scale scores
Time frame: At baseline (pre-intervention) and immediately after completion of seed therapy]
The initial version of the scale consisted of 34 items, but was later revised by the authors and shortened to 15 items (21). The short version of the scale consists of 15 items and 5 sub-dimensions. Each item is scored between 0-5 (0=Strongly disagree, 1=Disagree, 2=Undecided, 3=Somewhat agree, 4=Agree, 5=Strongly agree). The scale is evaluated out of a total of 75 points.
1 secondary outcome
Oswestry Disability Index scores
Time frame: At baseline (pre-intervention) and immediately after completion of seed therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Reference linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. Research results will be shared
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
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.
Esra GÜNEY, PhD principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing seed therapy (su-jok) in people with Pregnancy Related, run by Inonu 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 5 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prenatal Comfort Scale scores (time frame: At baseline (pre-intervention) and immediately after completion of seed therapy]). 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 5 Feb 2026.