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NCT Number: NCT05367414

Aromatherapy Massage for Itching Management in Liver Diseases

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.

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Key information

Conditions

Aromatherapy Digestive System Diseases Itching Liver Diseases Massage Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin Moisture Skin and Connective Tissue Diseases pH Level

Age range

37 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Artvin Coruh University

Artvin, Turkey (Türkiye)

About this study

This randomised controlled trial was conducted in order to examine study effect of aromatherapy massage on itching, comfort, skin pH level, and skin moisture among individuals with liver diseases

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aromatherapy massage (diluted tea tree oil)

Other

massage with diluted tea tree oil was applied

aromatherapy massage (sweet almond oil)

Other

massage with sweet almond oil was applied

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. skin moisture level

    Time frame: Day 1

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

  10. skin moisture level

    Time frame: Day 2

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

  11. skin moisture level

    Time frame: Day 14

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

Sponsors and collaborators

Lead sponsor

Amine Terzi

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 10, 2022
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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