search
Back to results

Aromatherapy Massage for Itching Management in Liver Diseases

Primary Purpose

Aromatherapy, Massage, Liver Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
aromatherapy massage (diluted tea tree oil)
aromatherapy massage (sweet almond oil)
Sponsored by
Amine Terzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aromatherapy focused on measuring aromatherapy, massage, liver Diseases, itching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Artvin Coruh University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

aromatherapy

placebo

control

Arm Description

In addition to routine medical treatment, massage with diluted tea tree oil was applied to the individuals in this group.

Individuals in this group were provided massage with sweet almond oil in addition to routine medical treatment.

Individuals in this group received only routine medical treatment.

Outcomes

Primary Outcome Measures

Itching
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.
Itching
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.
comfort
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.
comfort
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.
comfort
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.
skin pH level
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.
skin pH level
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.
skin pH level
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.
skin moisture level
DMM brand skin moisture measuring device was used to measure skin moisture level.
skin moisture level
DMM brand skin moisture measuring device was used to measure skin moisture level.
skin moisture level
DMM brand skin moisture measuring device was used to measure skin moisture level.

Secondary Outcome Measures

Full Information

First Posted
April 18, 2022
Last Updated
May 5, 2022
Sponsor
Amine Terzi
search

1. Study Identification

Unique Protocol Identification Number
NCT05367414
Brief Title
Aromatherapy Massage for Itching Management in Liver Diseases
Official Title
The Effect of Aromatherapy Massage on Itching, Comfort, Skin pH Level, and Skin Moisture in Liver Diseases: Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 13, 2020 (Actual)
Primary Completion Date
May 3, 2021 (Actual)
Study Completion Date
June 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amine Terzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aromatherapy, Massage, Liver Diseases, Itching, pH Level, Skin Moisture
Keywords
aromatherapy, massage, liver Diseases, itching

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aromatherapy
Arm Type
Experimental
Arm Description
In addition to routine medical treatment, massage with diluted tea tree oil was applied to the individuals in this group.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Individuals in this group were provided massage with sweet almond oil in addition to routine medical treatment.
Arm Title
control
Arm Type
No Intervention
Arm Description
Individuals in this group received only routine medical treatment.
Intervention Type
Other
Intervention Name(s)
aromatherapy massage (diluted tea tree oil)
Intervention Description
massage with diluted tea tree oil was applied
Intervention Type
Other
Intervention Name(s)
aromatherapy massage (sweet almond oil)
Intervention Description
massage with sweet almond oil was applied
Primary Outcome Measure Information:
Title
Itching
Description
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.
Time Frame
Day 1
Title
Itching
Description
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.
Time Frame
Day 14
Title
comfort
Description
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.
Time Frame
Day 1
Title
comfort
Description
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.
Time Frame
Day 2
Title
comfort
Description
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.
Time Frame
Day 14
Title
skin pH level
Description
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.
Time Frame
Day 1
Title
skin pH level
Description
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.
Time Frame
Day 2
Title
skin pH level
Description
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.
Time Frame
Day 14
Title
skin moisture level
Description
DMM brand skin moisture measuring device was used to measure skin moisture level.
Time Frame
Day 1
Title
skin moisture level
Description
DMM brand skin moisture measuring device was used to measure skin moisture level.
Time Frame
Day 2
Title
skin moisture level
Description
DMM brand skin moisture measuring device was used to measure skin moisture level.
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amine TERZI, PHD
Organizational Affiliation
Artvin Coruh University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yasemin YILDIRIM, PHD
Organizational Affiliation
Ege University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fisun SENUZUN AYKAR, PHD
Organizational Affiliation
Izmir Tinaztepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ulus Salih AKARCA, PHD
Organizational Affiliation
Ege University
Official's Role
Study Chair
Facility Information:
Facility Name
Artvin Coruh University
City
Artvin
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Aromatherapy Massage for Itching Management in Liver Diseases

We'll reach out to this number within 24 hrs