NCT06772129

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Feb 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Feb 2025Jun 2026

First Submitted

Initial submission to the registry

January 4, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

January 13, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 4, 2025

Last Update Submit

January 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • There is a difference between the delirium scores of aromatherapy and control elderly intensive care patients who have undergone fracture 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.

Study Arms (2)

aromatherapy group

ACTIVE COMPARATOR

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

control group

NO INTERVENTION

While normal care and treatment in intensive care will continue to be applied to this group, necessary measurements will be taken and recorded.

Interventions

Studies have been reviewed and no lavender aromatherapy has been found to be used for delirium.

aromatherapy group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Mosk CA, Mus M, Vroemen JP, van der Ploeg T, Vos DI, Elmans LH, van der Laan L. Dementia and delirium, the outcomes in elderly hip fracture patients. Clin Interv Aging. 2017 Mar 10;12:421-430. doi: 10.2147/CIA.S115945. eCollection 2017.

  • French J, Weber T, Ge B, Litofsky NS. Postoperative Delirium in Patients After Brain Tumor Surgery. World Neurosurg. 2021 Nov;155:e472-e479. doi: 10.1016/j.wneu.2021.08.089. Epub 2021 Aug 26.

  • Askarkafi F, Rayyani M, Dehghan M. The Effect of Massage With and Without Aromatic Oil on Delirium After Open-Heart Surgery: A Randomized Controlled Trial. J Chiropr Med. 2020 Mar;19(1):49-57. doi: 10.1016/j.jcm.2019.08.001. Epub 2020 Sep 3.

Related Links

MeSH Terms

Conditions

Emergence Delirium

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Saide Faydalı, Associate Professor

    Necmettin Erbakan University, Faculty of Nursing

    STUDY DIRECTOR

Central Study Contacts

şenay Gökdemir, specialist nurse

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
specialist nurse

Study Record Dates

First Submitted

January 4, 2025

First Posted

January 13, 2025

Study Start

February 1, 2025

Primary Completion

February 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

January 13, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share