HemodialysisNCT04666363
Inhaled Lavender Applied at Hemodialysis Patients and Effect on Pain, Comfort, and Anxiety
A study testing Lavender oil in people with Hemodialysis, run by Istanbul Demiroglu Bilim University at 1 site in Turkey (Türkiye).
Trial summary
The procedure of puncturing during needle insertion and moving needles within the tissues, the insertion angle, diameter of needles, and insertion techniques all lead the patient to experience pain. However, patients tolerate needle insertion more easily when the pain is managed well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Lavender oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2021to 30 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- On maintenance hemodialysis three times per week for four hours per session
- Receiving hemodialysis therapy for a least six moths at the time of the study
- Having the ability to smell
- Able to communicate in Turkish
- Willing to participate to the study
Who cannot join
- 18 years of age younger
- Absence of psychiatric disorders that cause cognitive dysfunction, such as Alzheimer's disease or chronic psychosis
- Pregnant women, patients with a history of allergies, respiratory diseases, neuropathy and peripheral vascular diseases
- Administered with painkillers in the past 3 hours
- Having infection at the fistula area
- Requiring more than one attempt for fistula puncturing
- Unwilling to to participate to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Long-term Inhaled Lavender Applied to Hemodialysis Patients on Invasive Pain Experienced During Cannulation, Patient Comfort, and Anxiety
The procedure of puncturing during needle insertion and moving needles within the tissues, the insertion angle, diameter of needles, and insertion techniques all lead the patient to experience pain. However, patients tolerate needle insertion more easily when the pain is managed well. Therefore, pharmacological and non-pharmacological methods are needed in pain control in order to improve comfort when undergoing hemodialysis (HD), and to facilitate patient's compliance to treatment over a longer period. Being one of the non-pharmacological practices, aromatherapy is a part of phototherapy, which means "therapy with plants" and also aims to manage symptoms such as pain as well as the treatment itself.
Read the detailed description
Experience of the arteriovenous fistula puncture-related pain can have unpleasant effects on the patients, it causes that hemodialysis patients experience more disability, depression, irritability, and insomnia than other patients in adapting to stress. Experiencing continued pain can also affect the level of hemodialysis acceptance in patients and ultimately decrease quality of life. Therefore, pain control is an important priority in these patients. In this regard, in various studies, different pharmacological and non-pharmacological approaches have been used to alleviate the pain.
- Conditions
- Hemodialysis
- Being tested
- Lavender oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender oilOther
the essence was diluted 1:10 with sweet almond oil. A cotton ball soaked in 3 drops of diluted lavender essence was kept at a 10 cm distance from the patients' nose and they were asked to breathe slowly for 5 min.
| Study group | Role | What they receive |
|---|---|---|
| Lavender oil | Experimental | On the first day (before intervention), the intensity of needle insertion-related pain was measured. The experimental group inhaled lavender essence (12 consecutive hemodialysis seasons). Receives: Other: Lavender oil |
| Control group | No intervention | The patients will not smell lavender oil. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline invasive pain at one month
It will be assessed at the end of the dialysis session with Visual Analogue Scale. Pain intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. The high point describes bad outcome
Measured: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
Change from baseline comfort at one month
It will be assessed first dialysis session and at the end of the 12th dialysis session by the nurse. The lowest point is one, the highest point is five. The high point describes good comfort
Measured: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
Change from baseline anxiety at one month
It will be assessed with Hospital Anxiety and Depression Scale. This scale, which has a two-factor structure is comprised of 14 items. Seven of these items assess the anxiety status and the remaining seven assess depression.
Each item is scored on a four-point scale. Total score ranges between 0 and 21 for anxiety and depression. Scores between 0 and 7 indicate normal emotional status.
Measured: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start15 Feb 2021
- Primary completion30 Apr 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Demiroglu Bilim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Ozen, Istanbul Demiroglu Bilim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666363
- Sponsor's protocol ID
- 20978
- Status last verified
- Aug 2021
- First submitted
- 8 Dec 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jafari-Koulaee A, Moosazadeh M, Bagheri Nesami M, Goudarzian AH. Effect of cryotherapy on arteriovenous fistula puncture-related pain in hemodialysis patients: A systematic review and meta-analysis. Complement Ther Med. 2020 Mar;49:102326. doi: 10.1016/j.ctim.2020.102326. Epub 2020 Jan 22.
PubMed 32147063Bouya S, Ahmadidarehsima S, Badakhsh M, Balouchi A, Koochakzai M. Effect of aromatherapy interventions on hemodialysis complications: A systematic review. Complement Ther Clin Pract. 2018 Aug;32:130-138. doi: 10.1016/j.ctcp.2018.06.008. Epub 2018 Jun 13.
PubMed 30057040Lakhan SE, Sheafer H, Tepper D. The Effectiveness of Aromatherapy in Reducing Pain: A Systematic Review and Meta-Analysis. Pain Res Treat. 2016;2016:8158693. doi: 10.1155/2016/8158693. Epub 2016 Dec 14.
PubMed 28070420
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Long-term Inhaled Lavender Applied to Hemodialysis Patients on Invasive Pain Experienced During Cannulation, Patient Comfort, and Anxiety
- ClinicalTrials.gov ID
- NCT04666363
- Acronym / sponsor ID
- 20978
- Conditions
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul Demiroglu Bilim UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 14 Dec 2020 (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 procedure of puncturing during needle insertion and moving needles within the tissues, the insertion angle, diameter of needles, and insertion techniques all lead the patient to experience pain. However, patients tolerate needle insertion more easily when the pain is managed well. Therefore, pharmacological and non-pharmacological methods are needed in pain control in order to improve comfort when undergoing hemodialysis (HD), and to facilitate patient's compliance to treatment over a longer period. Being one of the non-pharmacological practices, aromatherapy is a part of phototherapy, which means "therapy with plants" and also aims to manage symptoms such as pain as well as the treatment itself.
Detailed description
Experience of the arteriovenous fistula puncture-related pain can have unpleasant effects on the patients, it causes that hemodialysis patients experience more disability, depression, irritability, and insomnia than other patients in adapting to stress. Experiencing continued pain can also affect the level of hemodialysis acceptance in patients and ultimately decrease quality of life. Therefore, pain control is an important priority in these patients. In this regard, in various studies, different pharmacological and non-pharmacological approaches have been used to alleviate the pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lavender oil | Experimental | Other: Lavender oilOn the first day (before intervention), the intensity of needle insertion-related pain was measured. The experimental group inhaled lavender essence (12 consecutive hemodialysis seasons). |
| Control group | No intervention | –The patients will not smell lavender oil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- On maintenance hemodialysis three times per week for four hours per session
- Receiving hemodialysis therapy for a least six moths at the time of the study
- Having the ability to smell
- Able to communicate in Turkish
Key exclusion criteria (7 listed)
- 18 years of age younger
- Absence of psychiatric disorders that cause cognitive dysfunction, such as Alzheimer's disease or chronic psychosis
- Pregnant women, patients with a history of allergies, respiratory diseases, neuropathy and peripheral vascular diseases
- Administered with painkillers in the past 3 hours
- Having infection at the fistula area
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 |
|---|---|---|
| Lavender oilthe essence was diluted 1:10 with sweet almond oil. A cotton ball soaked in 3 drops of diluted lavender essence was kept at a 10 cm distance from the patients' nose and they were asked to breathe slowly for 5 min. | Other | Lavender oil |
Primary outcome
Change from baseline invasive pain at one month
Time frame: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
It will be assessed at the end of the dialysis session with Visual Analogue Scale. Pain intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. The high point describes bad outcome
Change from baseline comfort at one month
Time frame: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
It will be assessed first dialysis session and at the end of the 12th dialysis session by the nurse. The lowest point is one, the highest point is five. The high point describes good comfort
Change from baseline anxiety at one month
Time frame: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
It will be assessed with Hospital Anxiety and Depression Scale. This scale, which has a two-factor structure is comprised of 14 items. Seven of these items assess the anxiety status and the remaining seven assess depression. Each item is scored on a four-point scale. Total score ranges between 0 and 21 for anxiety and depression. Scores between 0 and 7 indicate normal emotional status.
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 31 Aug 2021.
- Background: PubMed 32147063Jafari-Koulaee A, Moosazadeh M, Bagheri Nesami M, Goudarzian AH. Effect of cryotherapy on arteriovenous fistula puncture-related pain in hemodialysis patients: A systematic review and meta-analysis. Complement Ther Med. 2020 Mar;49:102326. doi: 10.1016/j.ctim.2020.102326. Epub 2020 Jan 22.
- Background: PubMed 30057040Bouya S, Ahmadidarehsima S, Badakhsh M, Balouchi A, Koochakzai M. Effect of aromatherapy interventions on hemodialysis complications: A systematic review. Complement Ther Clin Pract. 2018 Aug;32:130-138. doi: 10.1016/j.ctcp.2018.06.008. Epub 2018 Jun 13.
- Background: PubMed 28070420Lakhan SE, Sheafer H, Tepper D. The Effectiveness of Aromatherapy in Reducing Pain: A Systematic Review and Meta-Analysis. Pain Res Treat. 2016;2016:8158693. doi: 10.1155/2016/8158693. Epub 2016 Dec 14.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender oil in people with Hemodialysis, run by Istanbul Demiroglu Bilim 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 6 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 31 Aug 2021. 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. 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?
Change from baseline invasive pain at one month (time frame: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))). The study lists 3 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 NCT04666363, which also lists 3 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 31 Aug 2021.