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

August 28, 2021 updated by: Nurten Ozen, Istanbul Demiroglu Bilim University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34384
        • Demiroglu Bilim University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lavender oil
On the first day (before intervention), the intensity of needle insertion-related pain was measured. The experimental group inhaled lavender essence (12 consecutive hemodialysis seasons).
Other: Lavender oil
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.
No Intervention: Control group
The patients will not smell lavender oil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
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
Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))
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.
Baseline and one month (At the end of the between 1st and12th dialysis session (3 hemodialysis sessions are done every week))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Demiroglu Bilim University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (Actual)

December 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 28, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 20978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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