- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07265440
Effect of New Specialized Technique Using Effleurage Massage on Striae Gravidarum (EM/SG)
The Efficacy of Effleurage Massage on Striae Gravidarum During Pregnancy
The goal of this clinical trial is to learn if our new specialized technique using effleurage massage works to prevent striae gravidarum in primigravida. The main questions it aims to answer are:
Can our new specialized technique using effleurage massage prevent or even decrease the severity of striae gravidarum in primigravida ? What side effects may participants face when using our technique?
Participants will:
perform effleurage massage in transverse direction from medial to lateral only not back and forth, twice a day starting from the 17th week until the 28th week of pregnancy and three times a day starting from the 28th week of pregnancy for 10 minutes for each time until date of birth but from lateral to medial. It will be performed on the whole abdominal area extending from the diaphragm to the pupic area, also on both sides of the abdomen extending from the 12th rib to the iliac crest.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted to investigate if our new specialized technique using effleurage massage can prevent or even decrease the severity of striae gravidarum in primigravida .
Participants will:
perform effleurage massage in transverse direction from medial to lateral only not back and forth, twice a day starting from the 17th week until the 28th week of pregnancy and three times a day starting from the 28th week of pregnancy for 10 minutes for each time until date of birth but from lateral to medial. It will be performed on the whole abdominal area extending from the diaphragm to the pupic area, also on both sides of the abdomen extending from the 12th rib to the iliac crest.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kafr el-Sheikh Governorate
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Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt, 33511
- Outpatient Clinics, Faculty of Physical Therapy, Kafrelsheikh University, Egypt
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• All females will be primigravida.
- All females will be at the 17th week to the 20th week of gestation.
- Age of participants will range from 20-30 years.
- Their BMI will not exceed 28 kg/m.
Exclusion Criteria:
• Any dermal pathology.
- Psychiatric disorders.
- Skin tumor.
- Pregnant with more than one child.
- History or symptoms of premature birth.
- Placental abruption.
- History of abdominal surgeries.
- History of abdominal hernia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Efficacy of EM on SG
Each patient in this group will perform effleurage massage in transverse direction from medial to lateral only not back and forth, twice a day starting from the 17th week until the 28th week of pregnancy and three times a day starting from the 28th week of pregnancy for 10 minutes for each time until date of birth but from lateral to medial.
It will be performed on the whole abdominal area extending from the diaphragm to the pupic area, also on both sides of the abdomen extending from the 12th rib to the iliac crest.
|
effleurage massage was performed in transverse direction from medial to lateral only not back and forth, twice a day starting from the 17th week until the 28th week of pregnancy and three times a day starting from the 28th week of pregnancy for 10 minutes for each time until date of birth but from lateral to medial.
It will be performed on the whole abdominal area extending from the diaphragm to the pupic area, also on both sides of the abdomen extending from the 12th rib to the iliac crest.
|
|
Active Comparator: Efficacy of olive oil only on SG
They will apply olive oil only twice a day starting from the 17th week until the 28th week of pregnancy and three times a day starting from the 28th week of pregnancy until date of birth .
|
effleurage massage was performed in transverse direction from medial to lateral only not back and forth, twice a day starting from the 17th week until the 28th week of pregnancy and three times a day starting from the 28th week of pregnancy for 10 minutes for each time until date of birth but from lateral to medial.
It will be performed on the whole abdominal area extending from the diaphragm to the pupic area, also on both sides of the abdomen extending from the 12th rib to the iliac crest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in Striae Gravidarum severity
Time Frame: At 21 weeks of gestation, 29 weeks of gestation ,and 39 weeks of gestation
|
Severity of striae gravidarum will be assessed using INA score at three time points during pregnancy to evaluate progression and response to the intervention
|
At 21 weeks of gestation, 29 weeks of gestation ,and 39 weeks of gestation
|
Collaborators and Investigators
Sponsor
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-764
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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