The Use of St. John's Wort Oil With Massage in the Perineum During Childbirth

July 25, 2023 updated by: Rahime Bedir Fındık, Ankara City Hospital Bilkent

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

Recruiting

Conditions

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

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

  1. weak muscle strength
  2. moderate muscle strength
  3. strong 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rahime Bedir Findik, Dr, Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

August 30, 2023

Study Completion (Estimated)

September 30, 2023

Study Registration Dates

First Submitted

November 13, 2021

First Submitted That Met QC Criteria

December 8, 2021

First Posted (Actual)

December 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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