Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation

NCT06382701 | Completed

• 1 other identifier: Kayseri
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Patients

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• State and Trait Anxiety Inventory (STAI)

  before and after the study, for 1 month, 2 times

Study Arms (2)

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.

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.

Other: placebo

Interventions

aromatherapy OTHER

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.

Intervention

placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Melikgazi, Kayseri, 38260, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arteriovenous Fistula; Pain; Anxiety Disorders; Personal Satisfaction

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor's degree

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 24, 2024
• Study Start: September 6, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)