HemodialysisNCT06156930
Erciyes University Faculty of Health Sciences
A study testing Intervention group lavender oil in people with Hemodialysis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Sleep disorders are important to place among the symptoms frequently seen in hemodialysis patients. Among sleep disorders, restless legs syndrome is the most common. Restless legs syndrome, seen in patients receiving hemodialysis treatment, causes excessive daytime sleepiness and negatively affects the sleep quality… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Intervention group lavender oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2023to 12 Jun 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who are 18 years or older,
- Not pregnant and not planning a pregnancy,
- Having been diagnosed with restless leg syndrome according to the restless leg syndrome diagnostic scale and by a physician,
- Having at least mild restless leg syndrome according to the restless leg syndrome severity rating scale,
- Scoring 11 or above on the Epworth sleepiness scale,
- PSQI score an average of 5 and above,
Show all 12Show fewer
- Receiving hemodialysis treatment in hemodialysis units for at least 3 months and 3 sessions per week,
- Continuing dialysis treatment in the same institution,
- Able to walk independently,
- No changes in the treatment program before the massage and throughout the research process,
- Not having any allergies to the oils to be used,
- Individuals who can understand and communicate with Turkish will be included in the research
Who cannot join
- Those who are sensitive and/or have any allergies to the lavender oil to be used,
- Those who have lower leg problems that would prevent them from applying massage to the lower leg area,
- Have a history of mental or physical disability, including peripheral neuropathy, vascular problems in the legs,
- Epilepsy, Alzheimer's, Parkinson's, Multiple Sclerosis, etc. Those with a diagnosed neurological disease such as
- Pre-implemented,
- Those with respiratory system disorders,
- Patients who used other complementary and integrative therapies methods during the study period will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Sleep disorders are important to place among the symptoms frequently seen in hemodialysis patients. Among sleep disorders, restless legs syndrome is the most common. Restless legs syndrome, seen in patients receiving hemodialysis treatment, causes excessive daytime sleepiness and negatively affects the sleep quality of individuals.
- Conditions
- Hemodialysis
- Being tested
- Intervention group lavender oil, Placebo group sesame oil
- Keywords
- Hemodialysis, Restless leg syndrome, Aromatherapy massage, Sleep quality, Lavender oil
- Medical subject headings
- Restless Legs Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group lavender oilOther
Also called Lavender oil aromatherapy massage
The group will receive aromatherapy massage with a 5% mixture prepared with sesame oil and lavender oil for 10 minutes on both lower leg areas, three times a week for four weeks.
Placebo group sesame oilOther
Also called Sesame oil massage
The group will receive a massage with sesame oil on both lower leg areas for 10 minutes on each leg, three times a week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group Lavander | Experimental | The group will receive aromatherapy massage with a 5% mixture prepared with sesame oil and lavender oil for 10 minutes on both lower leg areas, three times a week for four weeks. Receives: Other: Intervention group lavender oil |
| Placebo group sesame | Placebo comparator | The group will receive a massage with sesame oil on both lower leg areas for 10 minutes on each leg, three times a week for four weeks. Receives: Other: Placebo group sesame oil |
| Control group | No intervention | Group of individuals receiving HD treatment who do not receive any treatment other than standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
RLS Severity Rating Scale
The RLS Severity Rating Scale was developed in 2003. The scale was applied in the selection of patients and in the weekly evaluation of RLS severity. The scale comprised ten questions; each question was scored between 0 and 4. Questions 1, 2, 4, 6, 7, and 8 were related to RLS symptoms, questions 5, 9, and 10 were related to the effect of the disease on the mental state and daily social activities of patients with RLS, and question 3 was about the diagnostic criteria of RLS. The overall score indicated the RLS severity. A minimum score of 0 and a maximum score of 40 could be obtained. A score between 1 and 10 corresponded to "mild," 11-20 "moderate," 21-30 "severe," and 31-40 "very severe" RLS.
Measured: Change compared to the initial score 1 month after aromatherapy massage application
Epworth Sleepiness Scale
Daytime sleepiness is determined with the scale developed in 1991. The scale consists of 8 questions in total and a high score from the scale indicates an increased level of daytime sleepiness. With this four-point Likert type scale, each question is rated between 0-3. In the evaluation of the scale; 0-5 points: normal, 6-10 points: normal but increased daytime sleepiness, 11-12 points: increased moderate daytime sleepiness, 13-15 points: increased moderate daytime sleepiness, 16-24 points: increased severe daytime sleepiness It is considered as sleepiness. The minimum score is 0, the maximum score is 24, and a total score of 11 or above indicates excessive daytime sleepiness of individuals.
Measured: Change compared to the initial score 1 month after aromatherapy massage application
Secondary outcomes (1)
Pittsburg Sleep Quality Index (PSQI)
PSQI is a reliable and valid index that measures sleep quality. The total score in the PSQI, which consists of 24 items and is divided into 7 sections (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorder, use of sleeping pills and daytime dysfunction), varies between 0-21, and the PSQI total score is 5 and below. A score above 5 indicates that the sleep quality is 'good', and a score above 5 indicates that the sleep quality is 'bad'.
Measured: Change compared to the initial score 1 month after aromatherapy massage application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start6 Dec 2023
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Model description
- three-armed
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Ayser DÖNER, TC Erciyes University
- Investigators
- AYSER DÖNER, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156930
- Sponsor's protocol ID
- Erciyes University Health
- Status last verified
- Jul 2024
- First submitted
- 16 Nov 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans.
Publications
Doner A, Tasci S. Effect of massage therapy with lavender oil on severity of restless legs syndrome and quality of life in hemodialysis patients. J Nurs Scholarsh. 2022 May;54(3):304-314. doi: 10.1111/jnu.12738. Epub 2021 Nov 14.
PubMed 34779137Ghasemi M, Rejeh N, Bahrami T, Heravi-Karimooi M, Tadrisi SD, Vaismoradi M. Aromatherapy Massage vs. Foot Reflexology on the Severity of Restless Legs Syndrome in Female Patients Undergoing Hemodialysis. Geriatrics (Basel). 2021 Oct 11;6(4):99. doi: 10.3390/geriatrics6040099.
PubMed 34698176Hashemi SH, Hajbagheri A, Aghajani M. The Effect of Massage With Lavender Oil on Restless Leg Syndrome in Hemodialysis Patients: A Randomized Controlled Trial. Nurs Midwifery Stud. 2015 Dec;4(4):e29617. doi: 10.17795/nmsjournal29617. Epub 2015 Dec 1.
PubMed 26835466Malekshahi, F., Aryamanesh, F., Fallahi, S. 2018.
Mirbagher Ajorpaz N, Rahemi Z, Aghajani M, Hashemi SH. Effects of glycerin oil and lavender oil massages on hemodialysis patients' restless legs syndrome. J Bodyw Mov Ther. 2020 Jan;24(1):88-92. doi: 10.1016/j.jbmt.2019.06.012. Epub 2019 Jun 29.
PubMed 31987569Mohammadpourhodki R, Sadeghnezhad H, Ebrahimi H, Basirinezhad MH, Maleki M, Bossola M. The Effect of Aromatherapy Massage With Lavender and Citrus Aurantium Essential Oil on Quality of Life of Patients on Chronic Hemodialysis: A Parallel Randomized Clinical Trial Study. J Pain Symptom Manage. 2021 Mar;61(3):456-463.e1. doi: 10.1016/j.jpainsymman.2020.08.032. Epub 2020 Sep 1.
PubMed 32889038Muz G, Tasci S. Effect of aromatherapy via inhalation on the sleep quality and fatigue level in people undergoing hemodialysis. Appl Nurs Res. 2017 Oct;37:28-35. doi: 10.1016/j.apnr.2017.07.004. Epub 2017 Aug 1.
PubMed 28985917Nasiri M, Abbasi M, Khosroabadi ZY, Saghafi H, Hamzeei F, Amiri MH, Yusefi H. Short-term effects of massage with olive oil on the severity of uremic restless legs syndrome: A double-blind placebo-controlled trial. Complement Ther Med. 2019 Jun;44:261-268. doi: 10.1016/j.ctim.2019.05.009. Epub 2019 May 8.
PubMed 31126564Oshvandi K, Mirzajani Letomi F, Soltanian AR, Shamsizadeh M. The effects of foot massage on hemodialysis patients' sleep quality and restless leg syndrome: a comparison of lavender and sweet orange essential oil topical application. J Complement Integr Med. 2021 Apr 12;18(4):843-850. doi: 10.1515/jcim-2020-0121.
PubMed 33838094Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
PubMed 1798888Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisi J; Restless Legs Syndrome Diagnosis and Epidemiology workshop at the National Institutes of Health; International Restless Legs Syndrome Study Group. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med. 2003 Mar;4(2):101-19. doi: 10.1016/s1389-9457(03)00010-8.
PubMed 14592341Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17.
PubMed 25023924Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Hening WA, Allen RP. Restless legs syndrome (RLS): the continuing development of diagnostic standards and severity measures. Sleep Med. 2003 Mar;4(2):95-7. doi: 10.1016/s1389-9457(03)00009-1. No abstract available.
PubMed 14592339Walters AS, LeBrocq C, Dhar A, Hening W, Rosen R, Allen RP, Trenkwalder C; International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med. 2003 Mar;4(2):121-32. doi: 10.1016/s1389-9457(02)00258-7.
PubMed 14592342
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erciyes University Faculty of Health Sciences
- ClinicalTrials.gov ID
- NCT06156930
- Acronym / sponsor ID
- Erciyes University Health
- Conditions
- Hemodialysis
- Keywords
- Hemodialysis, Restless leg syndrome, Aromatherapy massage, Sleep quality, Lavender oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 5 Dec 2023 (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.
Sleep disorders are important to place among the symptoms frequently seen in hemodialysis patients. Among sleep disorders, restless legs syndrome is the most common. Restless legs syndrome, seen in patients receiving hemodialysis treatment, causes excessive daytime sleepiness and negatively affects the sleep quality of individuals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- three-armed
| Arm | Type | Receives |
|---|---|---|
| Intervention group Lavander | Experimental | Other: Intervention group lavender oilThe group will receive aromatherapy massage with a 5% mixture prepared with sesame oil and lavender oil for 10 minutes on both lower leg areas, three times a week for four weeks. |
| Placebo group sesame | Placebo comparator | Other: Placebo group sesame oilThe group will receive a massage with sesame oil on both lower leg areas for 10 minutes on each leg, three times a week for four weeks. |
| Control group | No intervention | –Group of individuals receiving HD treatment who do not receive any treatment other than standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Those who are 18 years or older,
- Not pregnant and not planning a pregnancy,
- Having been diagnosed with restless leg syndrome according to the restless leg syndrome diagnostic scale and by a physician,
- Having at least mild restless leg syndrome according to the restless leg syndrome severity rating scale,
- Scoring 11 or above on the Epworth sleepiness scale,
Key exclusion criteria (7 listed)
- Those who are sensitive and/or have any allergies to the lavender oil to be used,
- Those who have lower leg problems that would prevent them from applying massage to the lower leg area,
- Have a history of mental or physical disability, including peripheral neuropathy, vascular problems in the legs,
- Epilepsy, Alzheimer's, Parkinson's, Multiple Sclerosis, etc. Those with a diagnosed neurological disease such as
- Pre-implemented,
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 |
|---|---|---|
| Intervention group lavender oilAlso: Lavender oil aromatherapy massageThe group will receive aromatherapy massage with a 5% mixture prepared with sesame oil and lavender oil for 10 minutes on both lower leg areas, three times a week for four weeks. | Other | Intervention group Lavander |
| Placebo group sesame oilAlso: Sesame oil massageThe group will receive a massage with sesame oil on both lower leg areas for 10 minutes on each leg, three times a week for four weeks. | Other | Placebo group sesame |
Primary outcome
RLS Severity Rating Scale
Time frame: Change compared to the initial score 1 month after aromatherapy massage application
The RLS Severity Rating Scale was developed in 2003. The scale was applied in the selection of patients and in the weekly evaluation of RLS severity. The scale comprised ten questions; each question was scored between 0 and 4. Questions 1, 2, 4, 6, 7, and 8 were related to RLS symptoms, questions 5, 9, and 10 were related to the effect of the disease on the mental state and daily social activities of patients with RLS, and question 3 was about the diagnostic criteria of RLS. The overall score indicated the RLS severity. A minimum score of 0 and a maximum score of 40 could be obtained. A score between 1 and 10 corresponded to "mild," 11-20 "moderate," 21-30 "severe," and 31-40 "very severe" RLS.
Epworth Sleepiness Scale
Time frame: Change compared to the initial score 1 month after aromatherapy massage application
Daytime sleepiness is determined with the scale developed in 1991. The scale consists of 8 questions in total and a high score from the scale indicates an increased level of daytime sleepiness. With this four-point Likert type scale, each question is rated between 0-3. In the evaluation of the scale; 0-5 points: normal, 6-10 points: normal but increased daytime sleepiness, 11-12 points: increased moderate daytime sleepiness, 13-15 points: increased moderate daytime sleepiness, 16-24 points: increased severe daytime sleepiness It is considered as sleepiness. The minimum score is 0, the maximum score is 24, and a total score of 11 or above indicates excessive daytime sleepiness of individuals.
1 secondary outcome
Pittsburg Sleep Quality Index (PSQI)
Time frame: Change compared to the initial score 1 month after aromatherapy massage application
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 25 Jul 2024.
- Background: PubMed 34779137Doner A, Tasci S. Effect of massage therapy with lavender oil on severity of restless legs syndrome and quality of life in hemodialysis patients. J Nurs Scholarsh. 2022 May;54(3):304-314. doi: 10.1111/jnu.12738. Epub 2021 Nov 14.
- Background: PubMed 34698176Ghasemi M, Rejeh N, Bahrami T, Heravi-Karimooi M, Tadrisi SD, Vaismoradi M. Aromatherapy Massage vs. Foot Reflexology on the Severity of Restless Legs Syndrome in Female Patients Undergoing Hemodialysis. Geriatrics (Basel). 2021 Oct 11;6(4):99. doi: 10.3390/geriatrics6040099.
- Background: PubMed 26835466Hashemi SH, Hajbagheri A, Aghajani M. The Effect of Massage With Lavender Oil on Restless Leg Syndrome in Hemodialysis Patients: A Randomized Controlled Trial. Nurs Midwifery Stud. 2015 Dec;4(4):e29617. doi: 10.17795/nmsjournal29617. Epub 2015 Dec 1.
- BackgroundMalekshahi, F., Aryamanesh, F., Fallahi, S. 2018.
- Background: PubMed 31987569Mirbagher Ajorpaz N, Rahemi Z, Aghajani M, Hashemi SH. Effects of glycerin oil and lavender oil massages on hemodialysis patients' restless legs syndrome. J Bodyw Mov Ther. 2020 Jan;24(1):88-92. doi: 10.1016/j.jbmt.2019.06.012. Epub 2019 Jun 29.
- Background: PubMed 32889038Mohammadpourhodki R, Sadeghnezhad H, Ebrahimi H, Basirinezhad MH, Maleki M, Bossola M. The Effect of Aromatherapy Massage With Lavender and Citrus Aurantium Essential Oil on Quality of Life of Patients on Chronic Hemodialysis: A Parallel Randomized Clinical Trial Study. J Pain Symptom Manage. 2021 Mar;61(3):456-463.e1. doi: 10.1016/j.jpainsymman.2020.08.032. Epub 2020 Sep 1.
- Background: PubMed 28985917Muz G, Tasci S. Effect of aromatherapy via inhalation on the sleep quality and fatigue level in people undergoing hemodialysis. Appl Nurs Res. 2017 Oct;37:28-35. doi: 10.1016/j.apnr.2017.07.004. Epub 2017 Aug 1.
- Background: PubMed 31126564Nasiri M, Abbasi M, Khosroabadi ZY, Saghafi H, Hamzeei F, Amiri MH, Yusefi H. Short-term effects of massage with olive oil on the severity of uremic restless legs syndrome: A double-blind placebo-controlled trial. Complement Ther Med. 2019 Jun;44:261-268. doi: 10.1016/j.ctim.2019.05.009. Epub 2019 May 8.
- Background: PubMed 33838094Oshvandi K, Mirzajani Letomi F, Soltanian AR, Shamsizadeh M. The effects of foot massage on hemodialysis patients' sleep quality and restless leg syndrome: a comparison of lavender and sweet orange essential oil topical application. J Complement Integr Med. 2021 Apr 12;18(4):843-850. doi: 10.1515/jcim-2020-0121.
- Background: PubMed 1798888Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
- Background: PubMed 14592341Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisi J; Restless Legs Syndrome Diagnosis and Epidemiology workshop at the National Institutes of Health; International Restless Legs Syndrome Study Group. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med. 2003 Mar;4(2):101-19. doi: 10.1016/s1389-9457(03)00010-8.
- Background: PubMed 25023924Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17.
- Individual participant dataSharing planned: No. There are no plans.
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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.
AYSER DÖNER principal investigator
TC Erciyes 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 Intervention group lavender oil in people with Hemodialysis, run by TC Erciyes University 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 12 inclusion and 7 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 25 Jul 2024. 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?
RLS Severity Rating Scale (time frame: Change compared to the initial score 1 month after aromatherapy massage application). The study lists 2 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 NCT06156930, which also lists 15 linked publications.
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 25 Jul 2024.