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NCT Number: NCT05164926

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

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.

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Key information

Conditions

Perineal Injury

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perineal massage with St. John's Wort oil

Other

perineal massage with St. John's Wort oil during labor

Primary outcomes

  1. 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.

  2. Visual Analogua Scale

    Time frame: 5 minutes after birth

    The scale has 0-10 points.As The point increases the pain score increases

Secondary outcomes

  1. 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

    • weak muscle strength
    • moderate muscle strength
    • strong muscle strength

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rahime Bedir Findik, Dr

CONTACT

[email protected]

+905053166532

Zuhal Yapıcı Coşkun, Dr

CONTACT

[email protected]

+905327070119

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

The Effects of the Use of St. John's Wort Oil With Massage in the Perineum on Episiotomy, Perineal Damage and Wound Healing

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2021
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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