AromatherapyNCT05367414
Aromatherapy Massage for Itching Management in Liver Diseases
A study testing aromatherapy massage (diluted tea tree oil) and aromatherapy massage (sweet almond oil) in people with Aromatherapy and Massage, run by Amine Terzi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 37 to 88 years
- Conditions the study is for
- Aromatherapy, Massage, Liver Diseases
- What is being tested?
- aromatherapy massage (diluted tea tree oil) and aromatherapy massage (sweet almond oil)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Feb 2020to 23 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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
- Conditions
- Aromatherapy, Massage, Liver Diseases, Itching, pH Level, Skin Moisture
- Being tested
- aromatherapy massage (diluted tea tree oil), aromatherapy massage (sweet almond oil)
- Keywords
- aromatherapy, massage, liver Diseases, itching
- Medical subject headings
- Liver Diseases, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| aromatherapy | Experimental | In addition to routine medical treatment, massage with diluted tea tree oil was applied to the individuals in this group. Receives: 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. Receives: Other: aromatherapy massage (sweet almond oil) |
| control | No intervention | Individuals in this group received only routine medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 14
skin moisture level
DMM brand skin moisture measuring device was used to measure skin moisture level.
Measured: Day 1
skin moisture level
DMM brand skin moisture measuring device was used to measure skin moisture level.
Measured: Day 2
skin moisture level
DMM brand skin moisture measuring device was used to measure skin moisture level.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start13 Feb 2020
- Primary completion3 May 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AromatherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amine Terzi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amine Terzi, Artvin Coruh University
- Investigators
- Amine TERZI, PHD, Principal investigator, Artvin Coruh UniversityYasemin YILDIRIM, PHD, Study director, Ege UniversityFisun SENUZUN AYKAR, PHD, Study chair, Izmir Tinaztepe UniversityUlus Salih AKARCA, PHD, Study chair, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367414
- Sponsor's protocol ID
- Amine TERZİ
- Status last verified
- May 2022
- First submitted
- 18 Apr 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Terzi A, Yildirim Y, Aykar FS, Salih Akarca U. Does aromatherapy massage relieve itching?: A randomised controlled trial. J Tissue Viability. 2025 Feb;34(1):100831. doi: 10.1016/j.jtv.2024.11.003. Epub 2024 Nov 26.
PubMed 39627055
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy Massage on Itching, Comfort, Skin pH Level, and Skin Moisture in Liver Diseases: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05367414
- Acronym / sponsor ID
- Amine TERZİ
- Conditions
- Aromatherapy, Massage, Liver Diseases, Itching, pH Level, Skin Moisture
- Keywords
- aromatherapy, massage, liver Diseases, itching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Amine TerziUniversity, hospital or other
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aromatherapy | Experimental | Other: aromatherapy massage (diluted tea tree oil)In addition to routine medical treatment, massage with diluted tea tree oil was applied to the individuals in this group. |
| placebo | Placebo comparator | Other: aromatherapy massage (sweet almond oil)Individuals in this group were provided massage with sweet almond oil in addition to routine medical treatment. |
| control | No intervention | –Individuals in this group received only routine medical treatment. |
Who may qualify
- Ages
- 37 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aromatherapy massage (diluted tea tree oil)massage with diluted tea tree oil was applied | Other | aromatherapy |
| aromatherapy massage (sweet almond oil)massage with sweet almond oil was applied | Other | placebo |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
skin moisture level
Time frame: Day 1
DMM brand skin moisture measuring device was used to measure skin moisture level.
skin moisture level
Time frame: Day 2
DMM brand skin moisture measuring device was used to measure skin moisture level.
skin moisture level
Time frame: Day 14
DMM brand skin moisture measuring device was used to measure skin moisture level.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Derived from this study: PubMed 39627055Terzi A, Yildirim Y, Aykar FS, Salih Akarca U. Does aromatherapy massage relieve itching?: A randomised controlled trial. J Tissue Viability. 2025 Feb;34(1):100831. doi: 10.1016/j.jtv.2024.11.003. Epub 2024 Nov 26.
- Individual participant dataSharing planned: No
Related trials for Aromatherapy
Recruiting
The Effects of Wintergreen Essential Oil Inhalation on Alleviating Dyspnea Among Patients With Pneumonia
Pneumonia, Dyspnea
Recruiting
Aromatherapy Essential Oils to Manage Anxiety and Nausea in Cancer Patients Receiving Infusion in the Ambulatory Setting
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Recruiting
Rehabilitation of Taste and Smell Disorders Associated With Chemotherapy Using Aromatherapy
Cancer
Active, not recruiting
Deep Breathing Relaxation and Lemongrass Aromatherapy on Pain
Chronic Kidney Disease; End-Stage Renal Disease; Hemodialysis; Pain; Anxiety
Enrolling by invitation
The Effect of Peppermint Oil Aromatherapy on Pain, Functional Capacity and Cost in Fibromyalgia Patients
Fibromyalgia, Aromatherapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amine TERZI, PHD principal investigator
Artvin Coruh University
Yasemin YILDIRIM, PHD study director
Ege University
Fisun SENUZUN AYKAR, PHD study chair
Izmir Tinaztepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aromatherapy massage (diluted tea tree oil) and aromatherapy massage (sweet almond oil) in people with Aromatherapy and Massage, run by Amine Terzi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Itching (time frame: Day 1). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05367414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.