Pregnancy RelatedNCT07389668
The Effect of the Use of Hand Massage Stimulation Techniques on the Hyperemesis Gravidarum
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 effect of the use of hand massage stimulation techniques on nausea-vomiting severity and quality of life in pregnant women diagnosed with hyperemesis gravidarum. 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
- 70 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,
- Who can read and write,
- Who do not have any psychiatric disorders,
- Who are not experiencing a risky pregnancy,
- Who are hospitalized with a diagnosis of hyperemesis gravidarum,
- Who do not react negatively to any interventions aimed at touch, such as massage,
- Who have full and healthy tissue integrity in the area where the massage will be performed
Who cannot join
- Those whose pregnancy has ended for any reason,
- Those who have not been hospitalized despite being diagnosed,
- Pregnant women in the third trimester of pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Use of Hand Massage Stimulation Techniques on the Severity of Nausea-Vomiting and Quality of Life in Pregnant Women Diagnosed With Hyperemesis Gravidarum
The aim of this study is to determine the effect of the use of hand massage stimulation techniques on nausea-vomiting severity and quality of life in pregnant women diagnosed with hyperemesis gravidarum.
Research Hypotheses H1-a: The use of hand massage stimulation techniques in pregnant women diagnosed with hyperemesis gravidarum reduces the severity of nausea-vomiting.
Read more
H1-b: The use of hand massage stimulation techniques in pregnant women diagnosed with hyperemesis gravidarum increases the quality of life.
Data will be collected from pregnant women diagnosed with hyperemesis gravidarum in the maternity ward. It will be ensured that the midwifery intervention is implemented in a way that does not disrupt the examination routine. Seed therapy (su-jok) will be applied by researcher Esra Nur Emre, who has a basic level su jok therapy certificate.
Read the detailed description
The aim of this study is to determine the effect of the use of hand massage stimulation techniques on nausea-vomiting severity and quality of life in pregnant women diagnosed with hyperemesis gravidarum.
Data will be collected from pregnant women diagnosed with hyperemesis gravidarum in the maternity ward of Hatay Dörtyol State Hospital. 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 tools will be applied to pregnant women who agree to participate in the study by the researcher through face-to-face interviews. 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. After the pregnant women are given detailed information about the application, pain points will be determined according to the organ reflections on the hand. Green mung bean seeds, which are seeds used for nausea, will be fixed on the detected points and the fixed seed will be removed after 5-6 hours. The experimental group will be completed in two sessions in 24 hours. The second session will start with correct point detection and proceed in the same way as the first session. The procedure will be terminated after 5-6 hours. The PUQE (Nausea and Vomiting Severity Evaluation in Pregnancy) Test and the SF 36 Quality of Life Scale will be re-applied from the data collection forms. No intervention will be applied to the women in the control group, however, the Personal Information Form, Visual Analog Scale, PUQE (Nausea and Vomiting Severity Evaluation in Pregnancy) Test and the SF 36 Quality of Life Scale will be applied simultaneously with the experimental group.
- Conditions
- Pregnancy Related
- Being tested
- seed therapy (su jok)
- Keywords
- Nausea-vomiting, quality of life, pregnancy, massage, midwife
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 |
|---|---|---|
| Standard maintenance | No intervention | Group not receiving seed therapy (su jok) |
| seed therapy (su jok) | Experimental | Group that received seed therapy (su jok) Receives: Other: seed therapy (su jok) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea-vomiting severity scores
The Pregnancy Nausea and Vomiting Severity Assessment Test (PUQE) is a scoring system used to measure the severity of nausea and vomiting during pregnancy. The lowest score on the scale is 3 and the highest is 15. 0-3 indicates no symptoms, 4-6 indicates mild, 7-12 indicates moderate and 13-15 indicates severe nausea and vomiting during pregnancy.
Measured: Data collection forms were administered by the researcher using face-to-face interviews in the first stage (days 1-2 and 3), telephone interviews in the second stage (day 15), and face-to-face interviews again in the third stage (days 30-31).
Secondary outcomes (1)
Quality of life scores
SF-36 quality of life scale includes SF-36 YKÖ sub-dimensions of physical function 3rd question (options a, b, c, d, e, f, g, h, ı, j), social function 6th and 10th questions, physical role difficulty 4th question (options a, b, c, d), emotional role difficulty 5th question (options a, b, c), mental health 9th question b, c, d, f, h options, vitality/energy 9th question a, e, g, i options, pain 7th and 8th questions, general health 1st, 2nd and 11th questions (options a, b, c, d). SF-36 YKÖ is scored in a way that as the scores in the sub-dimensions increase, the quality of life also increases. With SF-36 YKÖ, both comprehensive quality of life and all sub-dimensions of quality of life are evaluated. The total score is between 0-100. As a result, a score of 0 indicates the worst health status, and a score of 100 indicates the best health status.
Measured: Data collection forms were administered by the researcher using face-to-face interviews in the first stage (days 1-2 and 3), telephone interviews in the second stage (day 15), and face-to-face interviews again in the third stage (days 30-31) .
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
- randomized controlled trial conducted with experimental and control groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Nur Emre, Inonu University
- Investigators
- Esra GÜNEY, PhD, Principal investigator, İnonu Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389668
- Sponsor's protocol ID
- 2024/128
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 the Use of Hand Massage Stimulation Techniques on the Severity of Nausea-Vomiting and Quality of Life in Pregnant Women Diagnosed With Hyperemesis Gravidarum
- ClinicalTrials.gov ID
- NCT07389668
- Acronym / sponsor ID
- 2024/128
- Conditions
- Pregnancy Related
- Keywords
- Nausea-vomiting, quality of life, pregnancy, massage, midwife
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 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 effect of the use of hand massage stimulation techniques on nausea-vomiting severity and quality of life in pregnant women diagnosed with hyperemesis gravidarum.
Research Hypotheses H1-a: The use of hand massage stimulation techniques in pregnant women diagnosed with hyperemesis gravidarum reduces the severity of nausea-vomiting.
H1-b: The use of hand massage stimulation techniques in pregnant women diagnosed with hyperemesis gravidarum increases the quality of life.
Data will be collected from pregnant women diagnosed with hyperemesis gravidarum in the maternity ward. It will be ensured that the midwifery intervention is implemented in a way that does not disrupt the examination routine. Seed therapy (su-jok) will be applied by researcher Esra Nur Emre, who has a basic level su jok therapy certificate.
Detailed description
The aim of this study is to determine the effect of the use of hand massage stimulation techniques on nausea-vomiting severity and quality of life in pregnant women diagnosed with hyperemesis gravidarum.
Data will be collected from pregnant women diagnosed with hyperemesis gravidarum in the maternity ward of Hatay Dörtyol State Hospital. 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 tools will be applied to pregnant women who agree to participate in the study by the researcher through face-to-face interviews. 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. After the pregnant women are given detailed information about the application, pain points will be determined according to the organ reflections on the hand. Green mung bean seeds, which are seeds used for nausea, will be fixed on the detected points and the fixed seed will be removed after 5-6 hours. The experimental group will be completed in two sessions in 24 hours. The second session will start with correct point detection and proceed in the same way as the first session. The procedure will be terminated after 5-6 hours. The PUQE (Nausea and Vomiting Severity Evaluation in Pregnancy) Test and the SF 36 Quality of Life Scale will be re-applied from the data collection forms. No intervention will be applied to the women in the control group, however, the Personal Information Form, Visual Analog Scale, PUQE (Nausea and Vomiting Severity Evaluation in Pregnancy) Test and the SF 36 Quality of Life Scale 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
- randomized controlled trial conducted with experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Standard maintenance | No intervention | –Group not receiving seed therapy (su jok) |
| seed therapy (su jok) | Experimental | Other: seed therapy (su jok)Group that received seed therapy (su jok) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant women who are over 18 years old,
- Who can read and write,
- Who do not have any psychiatric disorders,
- Who are not experiencing a risky pregnancy,
- Who are hospitalized with a diagnosis of hyperemesis gravidarum,
Key exclusion criteria (3 listed)
- Those whose pregnancy has ended for any reason,
- Those who have not been hospitalized despite being diagnosed,
- Pregnant women in the third trimester of pregnancy
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
Nausea-vomiting severity scores
Time frame: Data collection forms were administered by the researcher using face-to-face interviews in the first stage (days 1-2 and 3), telephone interviews in the second stage (day 15), and face-to-face interviews again in the third stage (days 30-31).
The Pregnancy Nausea and Vomiting Severity Assessment Test (PUQE) is a scoring system used to measure the severity of nausea and vomiting during pregnancy. The lowest score on the scale is 3 and the highest is 15. 0-3 indicates no symptoms, 4-6 indicates mild, 7-12 indicates moderate and 13-15 indicates severe nausea and vomiting during pregnancy.
1 secondary outcome
Quality of life scores
Time frame: Data collection forms were administered by the researcher using face-to-face interviews in the first stage (days 1-2 and 3), telephone interviews in the second stage (day 15), and face-to-face interviews again in the third stage (days 30-31) .
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.
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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
İnonu Üniversity
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 7 inclusion and 3 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?
Nausea-vomiting severity scores (time frame: Data collection forms were administered by the researcher using face-to-face interviews in the first stage (days 1-2 and 3), telephone interviews in the second stage (day 15), and face-to-face interviews again in the third stage (days 30-31).). 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.