Hemodialysis PatientsNCT06382701
Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation
A study testing aromatherapy in people with Hemodialysis Patients, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The most active members of the healthcare professionals responsible for hemodialysis units are nurses, and they have a key role in pain, anxiety and satisfaction management as they are responsible for cannulation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis Patients
- What is being tested?
- aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2021to 30 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who are over 18 years of age,
- Able to answer questions and communicate,
- No hearing, vision or speech impairments,
- Regularly undergoing hemodialysis three times a week,
- Having arterio-venous fistula for at least 3 months,
- Having pain during needle cannulation and scoring at least two or more points on the Visual Analogue Scale (VAS),
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- Having been on hemodialysis for at least three months,
- Agreeing to participate in the study with their own consent,
- Patients who are not allergic to clove oil will be included in the study.
Who cannot join
- Having neuropathic pain,
- Patients with arterio-venous fistula and loss of sensation of more than 50% in the extremity,
- Patients with infection in the arterio-venous fistula line,
- Patients with aneurysm or pseudoaneurysm in arterio-venous fistula,
- Patients who have used analgesic medication/s in the last 6 hours,
- Patients who have used sedative agent(s) in the last 6 hours,
- Patients who used local anesthetic agents before needle intervention will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Local Aromatherapy Applied to Hemodialysis Patients Before Arterio-venous Fistula Cannulation on Pain, Anxiety and Satisfaction
The most active members of the healthcare professionals responsible for hemodialysis units are nurses, and they have a key role in pain, anxiety and satisfaction management as they are responsible for cannulation. Therefore, complementary and integrated practices need to be implemented based on evidence to strengthen the independent role of nurses in managing pain and anxiety.
- Conditions
- Hemodialysis Patients
- Being tested
- aromatherapy, placebo
- Keywords
- clove oil, arteriovenous fistula, pain, anxiety, satisfaction, hemodialysis
- Medical subject headings
- Arteriovenous Fistula, Pain, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aromatherapyOther
Patients in the intervention group; ten minutes before the needle is inserted into the arterio-venous fistula, clove oil will be applied by the interviewer as a spray between 0.5-1 ml, depending on the length of the patient's fistula. Patients in the placebo group; 10 minutes before the needle is inserted into the arterio-venous fistula, 0.5-1 ml of aromatic cloves, which do not contain active ingredients and dissolved in pure water, will be applied as a spray by the interviewer, depending on the length of the patient's fistula.
placeboOther
This is the group in which 0.5-1 ml of aromatic clove, which does not contain active ingredients and is dissolved in pure water, is applied as a spray to the arterio-venous fistula area, depending on the length of the fistula, ten minutes before needle cannulation in all hemodialysis sessions for four weeks in individuals receiving standard hemodialysis treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | This is the group in which 0.5-1 ml of clove oil is applied as a spray to the arterio-venous fistula area, depending on the length of the fistula, ten minutes before needle cannulation in all hemodialysis sessions for four weeks in individuals receiving standard hemodialysis treatment. Receives: Other: aromatherapy |
| Placebo | Placebo comparator | This is the group in which 0.5-1 ml of aromatic clove, which does not contain active ingredients and is dissolved in pure water, is applied as a spray to the arterio-venous fistula area, depending on the length of the fistula, ten minutes before needle cannulation in all hemodialysis sessions for four weeks in individuals receiving standard hemodialysis treatment. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
This scale will be used in our study to evaluate the anxiety experienced by patients before needle cannulation and the pain and satisfaction experienced after needle cannulation.
Measured: before and after the intervention, for 1 month, 12 times
Secondary outcomes (1)
State and Trait Anxiety Inventory (STAI)
In our study, this scale will be used to evaluate the anxiety that patients may experience due to cannulation.
Measured: before and after the study, for 1 month, 2 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start6 Sep 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientsStudies 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
- The study was designed as a randomized controlled and double-blind study to evaluate the effect of clove oil applied to arterio-venous fistula on pain and anxiety caused by cannulation and to determine the effect of the application on satisfaction.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serife Cetin, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382701
- Sponsor's protocol ID
- Kayseri
- Status last verified
- Aug 2024
- First submitted
- 17 Apr 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Aromatherapy Applied to Hemodialysis Patients Before Arterio-venous Fistula Cannulation on Pain, Anxiety and Satisfaction
- ClinicalTrials.gov ID
- NCT06382701
- Acronym / sponsor ID
- Kayseri
- Conditions
- Hemodialysis Patients
- Keywords
- clove oil, arteriovenous fistula, pain, anxiety, satisfaction, hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 24 Apr 2024 (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 most active members of the healthcare professionals responsible for hemodialysis units are nurses, and they have a key role in pain, anxiety and satisfaction management as they are responsible for cannulation. Therefore, complementary and integrated practices need to be implemented based on evidence to strengthen the independent role of nurses in managing pain and anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The study was designed as a randomized controlled and double-blind study to evaluate the effect of clove oil applied to arterio-venous fistula on pain and anxiety caused by cannulation and to determine the effect of the application on satisfaction.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: aromatherapyThis is the group in which 0.5-1 ml of clove oil is applied as a spray to the arterio-venous fistula area, depending on the length of the fistula, ten minutes before needle cannulation in all hemodialysis sessions for four weeks in individuals receiving standard hemodialysis treatment. |
| Placebo | Placebo comparator | Other: placeboThis is the group in which 0.5-1 ml of aromatic clove, which does not contain active ingredients and is dissolved in pure water, is applied as a spray to the arterio-venous fistula area, depending on the length of the fistula, ten minutes before needle cannulation in all hemodialysis sessions for four weeks in individuals receiving standard hemodialysis treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Those who are over 18 years of age,
- Able to answer questions and communicate,
- No hearing, vision or speech impairments,
- Regularly undergoing hemodialysis three times a week,
- Having arterio-venous fistula for at least 3 months,
Key exclusion criteria (7 listed)
- Having neuropathic pain,
- Patients with arterio-venous fistula and loss of sensation of more than 50% in the extremity,
- Patients with infection in the arterio-venous fistula line,
- Patients with aneurysm or pseudoaneurysm in arterio-venous fistula,
- Patients who have used analgesic medication/s in the last 6 hours,
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 |
|---|---|---|
| aromatherapyPatients in the intervention group; ten minutes before the needle is inserted into the arterio-venous fistula, clove oil will be applied by the interviewer as a spray between 0.5-1 ml, depending on the length of the patient's fistula. Patients in the placebo group; 10 minutes before the needle is inserted into the arterio-venous fistula, 0.5-1 ml of aromatic cloves, which do not contain active ingredients and dissolved in pure water, will be applied as a spray by the interviewer, depending on the length of the patient's fistula. | Other | Intervention |
| placeboThis is the group in which 0.5-1 ml of aromatic clove, which does not contain active ingredients and is dissolved in pure water, is applied as a spray to the arterio-venous fistula area, depending on the length of the fistula, ten minutes before needle cannulation in all hemodialysis sessions for four weeks in individuals receiving standard hemodialysis treatment. | Other | Placebo |
Primary outcome
Visual Analog Scale (VAS)
Time frame: before and after the intervention, for 1 month, 12 times
This scale will be used in our study to evaluate the anxiety experienced by patients before needle cannulation and the pain and satisfaction experienced after needle cannulation.
1 secondary outcome
State and Trait Anxiety Inventory (STAI)
Time frame: before and after the study, for 1 month, 2 times
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 28 Aug 2024.
- 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 aromatherapy in people with Hemodialysis Patients, 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 9 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 28 Aug 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?
Visual Analog Scale (VAS) (time frame: before and after the intervention, for 1 month, 12 times). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2024.