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Completed

NCT Number: NCT04666363

Inhaled Lavender Applied at Hemodialysis Patients and Effect on Pain, Comfort, and Anxiety

The procedure of puncturing during needle insertion and moving needles within the tissues, the insertion angle, diameter of needles, and insertion techniques all lead the patient to experience pain. However, patients tolerate needle insertion more easily when the pain is managed well. Therefore, pharmacological and non-pharmacological methods are needed in pain control in order to improve comfort when undergoing hemodialysis (HD), and to facilitate patient's compliance to treatment over a longer period. Being one of the non-pharmacological practices, aromatherapy is a part of phototherapy, which means "therapy with plants" and also aims to manage symptoms such as pain as well as the treatment itself.

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Key information

Conditions

Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Demiroglu Bilim University

Istanbul, 34384, Turkey (Türkiye)

About this study

Experience of the arteriovenous fistula puncture-related pain can have unpleasant effects on the patients, it causes that hemodialysis patients experience more disability, depression, irritability, and insomnia than other patients in adapting to stress. Experiencing continued pain can also affect the level of hemodialysis acceptance in patients and ultimately decrease quality of life. Therefore, pain control is an important priority in these patients. In this regard, in various studies, different pharmacological and non-pharmacological approaches have been used to alleviate the pain.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • On maintenance hemodialysis three times per week for four hours per session
  • Receiving hemodialysis therapy for a least six moths at the time of the study
  • Having the ability to smell
  • Able to communicate in Turkish
  • Willing to participate to the study

Exclusion criteria

  • 18 years of age younger
  • Absence of psychiatric disorders that cause cognitive dysfunction, such as Alzheimer's disease or chronic psychosis
  • Pregnant women, patients with a history of allergies, respiratory diseases, neuropathy and peripheral vascular diseases
  • Administered with painkillers in the past 3 hours
  • Having infection at the fistula area
  • Requiring more than one attempt for fistula puncturing
  • Unwilling to to participate to the study

Treatment and study plan

Lavender oil

Other

the essence was diluted 1:10 with sweet almond oil. A cotton ball soaked in 3 drops of diluted lavender essence was kept at a 10 cm distance from the patients' nose and they were asked to breathe slowly for 5 min.

Primary outcomes

  1. Change from baseline invasive pain at one month

    Time frame: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))

    It will be assessed at the end of the dialysis session with Visual Analogue Scale. Pain intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. The high point describes bad outcome

  2. Change from baseline comfort at one month

    Time frame: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))

    It will be assessed first dialysis session and at the end of the 12th dialysis session by the nurse. The lowest point is one, the highest point is five. The high point describes good comfort

  3. Change from baseline anxiety at one month

    Time frame: Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))

    It will be assessed with Hospital Anxiety and Depression Scale. This scale, which has a two-factor structure is comprised of 14 items. Seven of these items assess the anxiety status and the remaining seven assess depression.

    Each item is scored on a four-point scale. Total score ranges between 0 and 21 for anxiety and depression. Scores between 0 and 7 indicate normal emotional status.

Sponsors and collaborators

Lead sponsor

Istanbul Demiroglu Bilim University

Other

Registry information

Official study title

Evaluation of the Effectiveness of Long-term Inhaled Lavender Applied to Hemodialysis Patients on Invasive Pain Experienced During Cannulation, Patient Comfort, and Anxiety

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 14, 2020
Registry last updated
Aug 31, 2021

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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