- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07389668
The Effect of the Use of Hand Massage Stimulation Techniques on the Hyperemesis Gravidarum
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.
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Malatya, Turkey (Türkiye)
- İnonu University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Standard maintenance
Group not receiving seed therapy (su jok)
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Experimental: seed therapy (su jok)
Group that received seed therapy (su jok)
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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).
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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.
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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).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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) .
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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.
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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) .
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Esra GÜNEY, PhD, İnonu University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 2024/128
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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