NCT05367414

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

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

February 13, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
Last Updated

January 29, 2025

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

April 18, 2022

Last Update Submit

January 27, 2025

Conditions

AromatherapyMassageLiver DiseasesItchingpH LevelSkin Moisture

Keywords

aromatherapymassageliver Diseasesitching

Outcome Measures

Primary Outcomes (11)

  • 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.

    Day 1

  • 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.

    Day 14

  • 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.

    Day 1

  • 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.

    Day 2

  • 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.

    Day 14

  • 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.

    Day 1

  • 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.

    Day 2

  • 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.

    Day 14

  • skin moisture level

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

    Day 1

  • skin moisture level

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

    Day 2

  • skin moisture level

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

    Day 14

Study Arms (3)

aromatherapy

EXPERIMENTAL

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)

placebo

PLACEBO COMPARATOR

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

Other: aromatherapy massage (sweet almond oil)

control

NO INTERVENTION

Individuals in this group received only routine medical treatment.

Interventions

aromatherapy massage (diluted tea tree oil)OTHER

massage with diluted tea tree oil was applied

aromatherapy
aromatherapy massage (sweet almond oil)OTHER

massage with sweet almond oil was applied

placebo

Eligibility Criteria

Age37 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Artvin Coruh University

Artvin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Liver DiseasesPruritus

Interventions

almond oil

Condition Hierarchy (Ancestors)

Digestive System DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amine TERZI, PHD

    Artvin Coruh University

    PRINCIPAL INVESTIGATOR

  • Yasemin YILDIRIM, PHD

    Ege University

    STUDY DIRECTOR

  • Fisun SENUZUN AYKAR, PHD

    Izmir Tinaztepe University

    STUDY CHAIR

  • Ulus Salih AKARCA, PHD

    Ege University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

April 18, 2022

First Posted

May 10, 2022

Study Start

February 13, 2020

Primary Completion

May 3, 2021

Study Completion

June 23, 2021

Last Updated

January 29, 2025

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)