The Effect of Aromatherapy on Delirium in Critically Elderly Patients Undergoing Fracture Surgery

January 8, 2025 updated by: Senay Gokdemir

The aim of this quasi-experimental study was to examine the effect of lavender aromatherapy on delirium in patients who underwent fracture surgery, were in intensive care, and were over 60 years old.

The main question of the study was, does lavender aromatherapy affect delirium scale scores? In order to examine the effect of lavender oil on delirium, the researcher will provide routine care to one group and apply aromatherapy to the other group.

Both groups will be evaluated by the researcher at eight-hour intervals with the Nu-DESC delirium screening scale and the results will be compared.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The American Nurses Association has defined delirium as "acute, serious, and often preventable conditions that are usually accompanied by confusion, dehydration, or attacks on some system followed by confusion and a distressing course of life". The incidence of delirium in the postoperative period is quite high and delirium has been associated with longer intensive care unit or hospital stays, higher hospital costs, and increased mortality. Delirium is especially risky in elderly and critically ill patients. Although postoperative delirium is tried to be treated using medication, nonpharmacological prevention methods are considered the most important part of the treatment. One of these methods is aromatherapy and has recently been widely used in nursing research. The smell of waste caused by patients' sweating, urinary and fecal incontinence, bleeding, and antiseptics such as povidone iodide, chlorhexidine, alcohol, and other drugs used during the treatment process creates a hospital-specific odor. Hospital odor is also associated with poor perception of treatment and care. It is thought that it would be beneficial to put an aromatic essential oil such as lavender oil in the environment. The positive effects of aromatherapy with lavender oil on anxiety, stress, pain, sleep quality, nausea and vomiting, as well as its sedative, emotionally calming, antiseptic, analgesic and antispasmodic properties have been demonstrated by studies. Essential oils are considered safe to use because they have minimal side effects. Postoperative delirium is a common complication following hip fracture surgery in the elderly. It has been observed that studies on the development of delirium in the intensive care unit were mostly conducted with patients who underwent cardiovascular surgery. This study will be carried out to determine how lavender oil aromatherapy left in the environment to prevent delirium, which can have serious consequences in the elderly with postoperative fractures, affects delirium scores.

Study Type

Interventional

Enrollment (Estimated)

108

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 Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Having had surgery for a fracture and being treated in the ICU
  • Being 60 years of age or older
  • Having a first measured Nu-Desc score of less than 2
  • Having a Glasgow coma scale score of >13
  • Being able to speak and understand Turkish

Exclusion Criteria:

  • Having trouble smelling
  • Being intubated
  • Having asthma, COPD or any respiratory disorder
  • Having been previously diagnosed with delirium
  • Having other cognitive disorders such as Alzheimer's or dementia
  • The patient needs to be physically restrained.
  • Having multiple fractures.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: aromatherapy group
The intervention to be performed in addition to routine care is to apply 0.3ml lavender oil to the aromatherapy necklace and leave it in an area 30 cm away from the patient's bed.
Other: Aromatherapy
Studies have been reviewed and no lavender aromatherapy has been found to be used for delirium.
No Intervention: control group
While normal care and treatment in intensive care will continue to be applied to this group, necessary measurements will be taken and recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
There is a difference between the delirium scores of aromatherapy and control elderly intensive care patients who have undergone fracture surgery.
Time Frame: The Nu-DESC score will be measured and recorded at 8-hour intervals for 24 hours after surgery.
The Nu-DESC scale will be used to diagnose delirium. The Nu-DESC is an observational five-item scale that can be completed quickly. Symptoms are graded from 0 to 2 based on the presence and intensity of each symptom. Delirium may be considered if the patient's total score is 2 or higher.
The Nu-DESC score will be measured and recorded at 8-hour intervals for 24 hours after surgery.

Collaborators and Investigators

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

Sponsor

Senay Gokdemir

Investigators

  • Study Director: Saide Faydalı, Associate Professor, Necmettin Erbakan University, Faculty of Nursing

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

Helpful Links

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 (Estimated)

February 1, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 4, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGokdemir

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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