Aromatherapy Massage for Itching Management in Liver Diseases

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05367414
• Other study ID #: Amine TERZI
• Status: Completed
• Phase: N/A
• Start date: February 13, 2020
• Est. completion date: June 23, 2021

Study information

• Verified date: May 2022
• Source: Artvin Coruh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 23, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aromatherapy
• Itching
• Liver Diseases
• Massage
• Pruritus

Intervention

Other:
• aromatherapy massage (diluted tea tree oil)
massage with diluted tea tree oil was applied
• aromatherapy massage (sweet almond oil)
massage with sweet almond oil was applied

Locations

Country	Name	City	State
Turkey	Artvin Coruh University	Artvin

Sponsors (1)

Lead Sponsor	Collaborator
Amine Terzi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	skin moisture level	DMM brand skin moisture measuring device was used to measure skin moisture level.	Day 1
Primary	skin moisture level	DMM brand skin moisture measuring device was used to measure skin moisture level.	Day 2
Primary	skin moisture level	DMM brand skin moisture measuring device was used to measure skin moisture level.	Day 14