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Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation

The Effect of Local Aromatherapy Applied to Hemodialysis Patients Before Arterio-venous Fistula Cannulation on Pain, Anxiety and Satisfaction

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06382701
Enrollment
60
Registered
2024-04-24
Start date
2021-09-06
Completion date
2024-06-30
Last updated
2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Patients

Keywords

clove oil, arteriovenous fistula, pain, anxiety, satisfaction, hemodialysis

Brief 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. Therefore, complementary and integrated practices need to be implemented based on evidence to strengthen the independent role of nurses in managing pain and anxiety.

Interventions

OTHERaromatherapy

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.

OTHERplacebo

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.

Sponsors

TC Erciyes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Pre-cannulation spray application to the intervention and placebo groups will be provided by an interviewer trained by the researchers. Cannulations will be performed by nurses in the institution where the study is conducted. Data will be collected by the responsible nurses in the institutions. Patients participating in the study, researchers, and the nurse in charge will not know who is in the intervention and placebo groups. The research will be completed in twelve sessions over four weeks.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 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), * 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale (VAS)before and after the intervention, for 1 month, 12 timesThis 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.

Secondary

MeasureTime frameDescription
State and Trait Anxiety Inventory (STAI)before and after the study, for 1 month, 2 timesIn our study, this scale will be used to evaluate the anxiety that patients may experience due to cannulation.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026