NCT06545422

Brief Summary

The study was conducted to evaluate the effect of St. John's wort oil application on skin moisture in intensive care patients. The study is a prospective pre-test-post-test controlled experimental research.It has been observed that St. John's wort oil has an effect on the skin moisture of intensive care patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 3, 2024

Last Update Submit

August 7, 2024

Conditions

Keywords

skin moisturepressure ulcernursingSt. John's wort oil

Outcome Measures

Primary Outcomes (2)

  • Experimental Group Results

    Moisture measurement of the coccyx area was performed with a skin moisture meter.

    Measurements were made every day from day 0 to day 20. Measurements were made every day from day 0 to day 20.

  • Control Group Results

    Moisture measurement of the coccyx area was performed with a skin moisture meter.

    Measurements were made every day from day 0 to day 20. Measurements were made every day from day 0 to day 20.

Study Arms (2)

Experimental group

EXPERIMENTAL

70 experimental group patients participated in the study; St. John's wort oil was applied to the coccyx area(width 10cm, length 10cm) of the patient included in the study at the same times every day for 21 days, starting from Day 0. The first day of hospitalization is considered day 0 and skin moisture is measured. The skin is cleaned and dried. 4 or 5 drops of St. John's wort oil were dropped onto the area and applied with a cotton pad.The next day, skin moisture is measured then the skin is cleaned and dried and St. John's wort oil is applied again. This Process continues for 21 days and is recorded.

Other: St. John's wort oil

Control Group

OTHER

70 control group patients participated in the study; The skin protective barrier cream used in routine care of the coccyx region (width 10 cm, length 10 cm) of the patient included in the study was applied at the same hours every day for 21 days, starting from day 0. The first day of hospitalization is considered day 0 and skin moisture is measured. The skin is cleaned and dried.Barrier cream is applied to the patient's coccyx area.The next day, at the same time, skin moisture is measured, then the skin is cleaned and dried, and barrier cream is applied again.Transactions are made and recorded every day for 21 days.

Other: Barrier Cream

Interventions

To examine the effect of regularly applied St. John's Wort oil on skin moisture.

Experimental group

To examine the effect of regularly applied barrier cream on skin moisture.

Control Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Admission to intensive care due to internal diseases diagnosis
  • The patient is immobile
  • The area to be applied is determined as the Coccyx and the tissue in this area must be intact.
  • No allergy to St. John's Wort oil
  • No circulatory disorders in the applied area

You may not qualify if:

  • Having a complicated diagnosis such as cancer
  • Having any disease that has spread to the entire skin
  • Having an allergy to topical medications or plant extracts
  • The patient has different variations such as surgical operation and intensive care change (post-operative follow-up patient)
  • The patient has a diagnosis of a skin disease such as dermatitis
  • A wound in the coccyx area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşenur ÖZENÇ KOLUTEK

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Hypericum extract LI 160

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ayşenur ÖZENÇ KOLUTEK, researcher

    student of the institution

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective pretest-posttest controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

August 3, 2024

First Posted

August 9, 2024

Study Start

September 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations