Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation

NCT ID: NCT06382701

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-06
• Study Completion Date: 2024-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Intervention

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.

Group Type: ACTIVE_COMPARATOR

aromatherapy

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Serife Cetin

doctor's degree

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Erciyes University

Melikgazi, Kayseri, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Kayseri

Identifier Type: -

Identifier Source: org_study_id