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Completed

NCT Number: NCT06382701

Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation

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.

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Key information

Conditions

Hemodialysis Patients Anxiety Disorders Arteriovenous Fistula Arteriovenous Malformations Behavior Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Personal Satisfaction Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Melikgazi, Kayseri, 38260, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 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 outcomes

  1. State and Trait Anxiety Inventory (STAI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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