Aromatherapy Massage for Itching Management in Liver Diseases

May 5, 2022 updated by: Amine Terzi

The Effect of Aromatherapy Massage on Itching, Comfort, Skin pH Level, and Skin Moisture in Liver Diseases: Randomised Controlled Trial

The aim of this study is to determine the effect of aromatherapy massage on itching, comfort, skin pH level and skin moisture in individuals with liver disease.

Research Hypotheses:

H1: Aromatherapy massage has an effect on the level of itching in individuals with itchy liver disease.

H2: Aromatherapy massage has an effect on the general comfort level in individuals with itchy liver disease, H3: Aromatherapy massage has an effect on skin pH level in individuals with itchy liver disease.

H4: Aromatherapy massage has an effect on skin moisture in individuals with itchy liver disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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 Locations

  • Turkey
      • Artvin, Turkey
        • Artvin Çoruh University

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who volunteered to participate in the study,
  • with a diagnosis of chronic liver disease (liver cirrhosis (primary biliary cirrhosis, alcoholic, cardiac, post-necrotic, cryptogenic cirrhosis, Wilson's Cirrhosis, hemochromatosis), chronic viral hepatitis),
  • had no cognitive impairment,
  • were not included in the pre-application,
  • could answer questions,
  • itch score of above 3 (with Visual Analogue Scale).

Exclusion Criteria:

  • patients are taking antipruritic treatment,
  • have itchy skin disease before, ulcer, eczema, etc. in the area to be applied
  • patients with dermatological problems, any swelling or signs of inflammation in the area ---to be treated, neuropathy or loss of sensation in the area to be treated
  • patients with allergic to tea tree oil, perfume, or cosmetics,
  • diagnosed with cancer

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: aromatherapy
In addition to routine medical treatment, massage with diluted tea tree oil was applied to the individuals in this group.
Other: aromatherapy massage (diluted tea tree oil)
massage with diluted tea tree oil was applied
PLACEBO_COMPARATOR: placebo
Individuals in this group were provided massage with sweet almond oil in addition to routine medical treatment.
Other: aromatherapy massage (sweet almond oil)
massage with sweet almond oil was applied
NO_INTERVENTION: control
Individuals in this group received only routine medical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Itching
Time Frame: Day 1
Itching was assessed with the 5D Itch Scale. The total score of the scale ranges from 5 to 25, with 5 points indicating the absence of itching and 25 points indicating the highest severity of itching.
Day 1
Itching
Time Frame: Day 14
Itching was assessed with the 5D Itch Scale. The total score of the scale ranges from 5 to 25, with 5 points indicating the absence of itching and 25 points indicating the highest severity of itching.
Day 14
comfort
Time Frame: Day 1
Comfort assessed with the General Comfort Scale. The score to be obtained from the scale varies between 48 and 192. 48 points indicating the low comfort level and 192 points indicating the high comfort level.
Day 1
comfort
Time Frame: Day 2
Comfort assessed with the General Comfort Scale.The score to be obtained from the scale varies between 48 and 192. 48 points indicating the low comfort level and 192 points indicating the high comfort level.
Day 2
comfort
Time Frame: Day 14
Comfort assessed with the General Comfort Scale. The score to be obtained from the scale varies between 48 and 192. 48 points indicating the low comfort level and 192 points indicating the high comfort level.
Day 14
skin pH level
Time Frame: Day 1
For pH level measurement, the F-74 G model skin pH measuring device manufactured by HORIBA Scientific and ISFET (Ion Sensitive Field Effect Transistor) 0040-10D model pH electrode produced by HORIBA Scientific were used.
Day 1
skin pH level
Time Frame: Day 2
For pH level measurement, the F-74 G model skin pH measuring device manufactured by HORIBA Scientific and ISFET (Ion Sensitive Field Effect Transistor) 0040-10D model pH electrode produced by HORIBA Scientific were used.
Day 2
skin pH level
Time Frame: Day 14
For pH level measurement, the F-74 G model skin pH measuring device manufactured by HORIBA Scientific and ISFET (Ion Sensitive Field Effect Transistor) 0040-10D model pH electrode produced by HORIBA Scientific were used.
Day 14
skin moisture level
Time Frame: Day 1
DMM brand skin moisture measuring device was used to measure skin moisture level.
Day 1
skin moisture level
Time Frame: Day 2
DMM brand skin moisture measuring device was used to measure skin moisture level.
Day 2
skin moisture level
Time Frame: Day 14
DMM brand skin moisture measuring device was used to measure skin moisture level.
Day 14

Collaborators and Investigators

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

Sponsor

Amine Terzi

Investigators

  • Principal Investigator: Amine TERZI, PHD, Artvin Çoruh University
  • Study Director: Yasemin YILDIRIM, PHD, Ege University
  • Study Chair: Fisun SENUZUN AYKAR, PHD, Izmir Tinaztepe University
  • Study Chair: Ulus Salih AKARCA, PHD, Ege University

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)

February 13, 2020

Primary Completion (ACTUAL)

May 3, 2021

Study Completion (ACTUAL)

June 23, 2021

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (ACTUAL)

May 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Amine TERZİ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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