- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05164926
The Use of St. John's Wort Oil With Massage in the Perineum During Childbirth
The Effects of the Use of St. John's Wort Oil With Massage in the Perineum on Episiotomy, Perineal Damage and Wound Healing
Perineal trauma, whether spontaneous or episiotomy, is a condition that affects the quality of life in primiparous women . In women who have experienced perineal trauma, problems such as dyspareunia, urinary and fecal incontinence, and delayed attachment of mother and baby occur in their later lives. Episiotomy, which is applied to reduce perineal trauma, is not recommended today, but it is still widely used.Different techniques such as perineal massage, hot compress, and Ritgen maneuver are applied to reduce perineal trauma. Perineal Massage can be applied together with oil. There are studies in which massage is applied together with oils.St. John's Wort (St. John's Wort) is a plant used in traditional practice in Turkish medicine against ulcers in the gastrointestinal tract, diabetes, jaundice, hepatic and biliary diseases. Antitumoral , antimicrobial , antiviral activities have been demonstrated. St. John's Wort oil can be used orally for dyspeptic complaints, and there is also a way to apply it through the skin. When applied for this purpose, it benefits from its facilitating feature of wound healing. It is useful in wound healing, myalgia and minor bruises, burn pain .
The investigators'aim in this study is to investigate the effects of perineal massage with St. John's Wort oil on episiotomy, perineal damage and wound healing.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is a Prospective Cross-sectional Case Control study. 60 pregnant women who were admitted to the Delivery Room Clinic of the hospital for delivery and were in active labor and had a 6 cm gap of 70-80% in the examination were included in the study. High-risk pregnant women, pregnant women planned for cesarean delivery, and pregnant women with additional disease were excluded from the study. First of all, a patient follow-up form, which includes the demographic information of the pregnant women, examination and perineal length, ultrasound information including the estimated fetal weight of the baby, will be filled. 30 case group pregnant women will receive their consent following a detailed explanation. Then, perineal massage will be applied to the pregnant women who have reached full disclosure, which will last for 10 minutes in the 1st stage of labor, accompanied by centaury oil, to stretch the perineal muscles with the help of fingers. Also, the pregnant women who have reached full patency will be given a perineal massage until the head descends on the delivery table. Another 10-minute centaury oil massage will be applied.
The control group will consist of 30 pregnant women who were applied perineal massage without using centaury oil as a requirement of midwifery care service.
The rates of 3rd and 4th degree perineal damage will be recorded from the groups that received St. John's Wort oil after delivery and those who did not. The current cut-out size and depth and its localization will also be recorded. At the same time, the patient will be evaluated for VAS for postpartum perineal pain.
In the follow-up one week after discharge, the scar thickness and pelvic muscle strength assessment of the existing episioes and eruptions will be recorded. The presence of urinary or fecal incontinence will be recorded by asking.
The data will be saved in the IBM-SPSS program. When comparing the two groups, normally distributed data will be analyzed using the independent simple t test, and data not normally distributed will be analyzed using the Mann-Whitney U-Test. P value less than 0.05 will be considered significant.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rahime Bedir Findik, Dr
- Phone Number: +905053166532
- Email: drbedir75@gmail.com
Study Contact Backup
- Name: Zuhal Yapıcı Coşkun, Dr
- Phone Number: +905327070119
- Email: zuhalyapici@yahoo.com
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey, 06200
- Recruiting
- Rahime Bedir Findik
-
Contact:
- Rahime Bedir Findik
- Email: drbedir75@gmail.com
-
Contact:
- Zuhal Yapici Coskun, Dr
- Phone Number: +905327070119
- Email: zuhalyapici@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- normal pregnant women
- active labor during the examination
- pregnant woman who is likely to have a vaginal delivery
Exclusion Criteria:
.Pregnant women with risky pregnancies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group, whose perineum was massaged with St. John's Wort oil during labor
St. John's Wort oil will be applied to this group during perineal massage during labor.
|
perineal massage with St. John's Wort oil during labor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of 3rd and 4th degree perineal damage
Time Frame: 5 minutes after birth
|
The presence of 3rd and 4th degree perineal tears will be recorded by examination immediately after birth.
|
5 minutes after birth
|
Visual Analogua Scale
Time Frame: 5 minutes after birth
|
The scale has 0-10 points.As The point increases the pain score increases
|
5 minutes after birth
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
perineal muscle strength
Time Frame: postpartum at week 1
|
Evaluation of perineal muscle strength by examination: The scale has 0-3 points. It is scored between a minimum of 0 and a maximum of 3.As the point increases the perineal muscle strenght score increases. 0: no muscle strength
|
postpartum at week 1
|
wound healing-wound color
Time Frame: postpartum at week 1
|
Evaluation of wound color: The scale has 0-1 points.It is scored as 1 if the wound color is red and as zero (0) if it is not red.
|
postpartum at week 1
|
wound healing-wound inflamation
Time Frame: postpartum at week 1
|
Evaluation of wound inflamation: The scale has 0-1 points.
It is scored as 1 if the wound is inflamed due to infection, and as zero (0) if it is not.
|
postpartum at week 1
|
wound healing-wound heat
Time Frame: postpartum at week 1
|
Evaluation of wound heat:The scale has 0-1 points.It is scored as 1 if there is an increase wound heat and zero (0) if there is none.
|
postpartum at week 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rahime Bedir Findik, Dr, Ankara City Hospital Bilkent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- AnkaraCHBilkent-MH-RBF-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Perineal Injury
-
Bertuit JeanneUniversité de KinshasaRecruitingSexual Violence | Perineal Injury | Woman AbuseCongo, The Democratic Republic of the
-
Asmaa Abdallah Ahmed HusseinCairo UniversityCompleted
-
Universita di VeronaCompletedPerineal Tear | Delivery; Injury, Maternal | Episiotomy WoundItaly
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiCompleted
-
London North West Healthcare NHS TrustRecruitingAnal Incontinence | Faecal Incontinence | Follow-up | Biofeedback | Obstetric Anal Sphincter Injury | Urogynaecology | Urgency | Severe Perineal Trauma | Grade 3 Perineal Tear | Grade 4 Perineal Tear | Deferral Time | Pathways | Review | Endo-anal UltrasoundUnited Kingdom
-
Croydon Health Services NHS TrustCompletedAnal Sphincter Injury | Obstetric Trauma | Perineal Infection | Perineum; InjuryUnited Kingdom
-
Centre Hospitalier Universitaire de NīmesCompleted
-
Centre Hospitalier Universitaire de NīmesCompletedRetrospective Evaluation of Functional and Sexological Results of Surgical Perineal Repair (SEX-RPC)Complications; Perineal RepairFrance
-
Clinical Research Centre, MalaysiaCompletedPerineal Tear | Perineal Laceration (Obstetric)
-
Massachusetts General HospitalEnrolling by invitationPerineal Tear | Delivery; Trauma | Perineal LacerationUnited States
Clinical Trials on perineal massage with St. John's Wort oil
-
Ceres Heilmittel AGUniversity of ZurichCompleted
-
Mayo ClinicNational Cancer Institute (NCI)Completed
-
Mayo ClinicCompletedIrritable Bowel SyndromeUnited States
-
University of Southern DenmarkCompleted
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedLymphoma | Myelodysplastic Syndromes | Leukemia | Fatigue | Chronic Myeloproliferative Disorders | Unspecified Adult Solid Tumor, Protocol Specific | Multiple Myeloma and Plasma Cell Neoplasm | Precancerous ConditionUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)TerminatedBreast Cancer | Hot FlashesUnited States
-
Soroka University Medical CenterUnknownSecond Stage of LaborIsrael
-
National Center for Complementary and Integrative...Completed
-
National Center for Complementary and Integrative...CompletedObsessive Compulsive DisorderUnited States
-
The University of QueenslandCompletedAnxiety Disorders | Depressive Disorder, MajorAustralia