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RecruitingNCT05164926Updated Jul 31, 2024

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

An interventional study of perineal massage with St. John's Wort oil in Perineal Injury, sponsored by Ankara City Hospital Bilkent. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Perineal Injury

Keywords

  • perineal injury
  • perineal massage
  • St. John's Wort oil
  • Visual analogue scoring
  • episiotomy
03

In context

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • normal pregnant women
  • active labor during the examination
  • pregnant woman who is likely to have a vaginal delivery

Exclusion criteria

Exclusion Criteria:

.Pregnant women with risky pregnancies

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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.

    Other: perineal massage with St. John's Wort oil

Interventions

  • Otherperineal massage with St. John's Wort oil

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

06

What researchers measure

Primary outcomes

  1. Presence of 3rd and 4th degree perineal damage

    The presence of 3rd and 4th degree perineal tears will be recorded by examination immediately after birth.

    Time frame: 5 minutes after birth

  2. Visual Analogua Scale

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

    Time frame: 5 minutes after birth

Secondary outcomes

  1. perineal muscle strength

    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

    Time frame: postpartum at week 1

  2. wound healing-wound color

    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.

    Time frame: postpartum at week 1

  3. wound healing-wound inflamation

    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.

    Time frame: postpartum at week 1

  4. wound healing-wound heat

    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.

    Time frame: postpartum at week 1

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05164926
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Rahime Bedir Fındık (Associate Professor Dr, Ankara City Hospital Bilkent) — Principal investigator
First posted
Dec 21, 2021
Start date
May 15, 2023
Primary completion
Oct 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Jul 31, 2024

Study contacts

Rahime Bedir Findik, Dr
Contact
drbedir75@gmail.com
+905053166532
Zuhal Yapıcı Coşkun, Dr
Contact
zuhalyapici@yahoo.com
+905327070119
Rahime Bedir Findik, Dr
principal investigator · Ankara City Hospital Bilkent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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