NCT05377983

Brief Summary

Cardiovascular diseases are among the important health problems due to their increasing frequency and extensity in developed and developing countries. The most common method of treating cardiovascular diseases is Coronary Artery Bypass Graft (CABG) surgery. Common pain, sleep problems, and anxiety after CABG surgery can cause delay in postoperative recovery both physically and mentally. The study was planned to evaluate the effect of lavender oil inhalation on pain, anxiety level and sleep quality after CABG surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2023

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

April 18, 2022

Last Update Submit

May 11, 2022

Conditions

Keywords

lavender oilpainanxietysleep

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

    Pain intensity, will be evaluated by NRS 3 times a day in the intervention and control group upon admission from the intensive care unit to the clinic, before and 30 minutes and four hours after each analgesic administration.In addition to this application, pain intensity will be evaluated with NRS before and five minutes after lavender oil inhalation in intervention group patients.

    Up to five days

  • Anxiety level

    Anxitey level will be evaluated using the STAI-I at four hours after analgesic administration in the intervention group and at five minutes after lavender oil inhalation.

    Up to five days

  • Sleep quality

    Sleep quality will also be evaluated using RCSQ every morning during.

    Up to five days

Study Arms (2)

the intervention group

EXPERIMENTAL

Lavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutes. Pain intensity and vital signs will be evaluated and recorded before each application and in the first five minutes after the application.

Other: Lavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutes

the control group

NO INTERVENTION

The control group will only receive routine care.

Interventions

During the hospitalization period after CABG surgery, 2% lavender oil (Lavandula angustifolia) inhalation will be applied to the intervention group three times a day.

the intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older,
  • undergoing elective CABG surgery,
  • negative lavender oil allergy test,
  • being conscious and oriented to place, person, and time,
  • not having any disability that would make communication difficult,
  • being able to communicate in Turkish, and
  • giving informed written consent to participate in the study.

You may not qualify if:

  • diagnosed with a sleep disorder or using any pharmacological and/or herbal medicine for insomnia,
  • being allergic to lavender, cosmetics, or perfume,
  • having a history of dermatitis,
  • sinusitis,
  • upper respiratory tract infection,
  • liver and kidney dysfunction,
  • asthma, and
  • chronic obstructive pulmonary disease,
  • not having regulated blood pressure,
  • having arrhythmia,
  • using patient-controlled analgesia after surgery,
  • not being able to communicate in Turkish.
  • a positive lavender oil allergy test,
  • development of lavender allergy during the study,
  • voluntarily deciding to leave the study, and
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yesim Dikmen Aydin

Maltepe, Istanbul, 34854, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • YEŞİM DİKMEN AYDIN

    Marmara University Faculty of Health Sciences,

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YEŞIM DIKMEN AYDIN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Lavender oil inhalation will be performed by placing two drops of 2% lavender oil on a 5x5 cm sterile gauze cloth and asking the patient to smell it for three to five minutes.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2022

First Posted

May 17, 2022

Study Start

June 17, 2021

Primary Completion

May 30, 2022

Study Completion

August 24, 2023

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations