Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation

Hemodialysis Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06382701
• Other study ID #: Kayseri
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 6, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

Other:
• aromatherapy
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.
• placebo
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.

Locations

Country	Name	City	State
Turkey	Erciyes University	Melikgazi	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	before and after the intervention, for 1 month, 12 times
Secondary	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.	before and after the study, for 1 month, 2 times