- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07389707
The Effect of Using Hand Massage Stimulation Techniques on Pain and Comfort in Pregnant Women Experiencing Lumbar Pain
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Battalgazi̇
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Malatya, Battalgazi̇, Turkey (Türkiye)
- İnonu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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 |
|---|---|
|
Experimental: seed therapy ( su-jok)
Group that received 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
|
|
No Intervention: standard maintenance
group not receiving seed therapy ( su- jok)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At baseline (pre-intervention) and immediately after completion of seed therapy]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry Disability Index scores
Time Frame: At baseline (pre-intervention) and immediately after completion of seed therapy
|
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.
|
At baseline (pre-intervention) and immediately after completion of seed therapy
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/129
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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