Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation

Not Applicable

Completed

• Conditions: Hemodialysis Patients
• Interventions: Other: aromatherapy; Other: placebo

• Registration Number: NCT06382701
• Lead Sponsor: TC Erciyes University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-06
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-24
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	aromatherapy	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Erciyes University; 🇹🇷 Melikgazi, Kayseri, Turkey