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The Effect of Lavender Oil Inhalation on Pain, Anxiety and Sleep Quality After Coronary Artery Bypass Graft

Primary Purpose

Coronary Artery Bypass Graft Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
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
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Bypass Graft Surgery focused on measuring lavender oil, pain, anxiety, sleep

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The inclusion criteria for the study were determined as follows:

    • 18 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.

Exclusion Criteria:

  • The exclusion criteria for the study were determined as follows:

    • 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.
  • The remaining exclusion criteria were determined as follows:

    • a positive lavender oil allergy test,
    • development of lavender allergy during the study,
    • voluntarily deciding to leave the study, and
    • not complying with the study process and conditions.

Sites / Locations

  • Yesim Dikmen AydinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

the intervention group

the control group

Arm Description

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.

The control group will only receive routine care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 18, 2022
Last Updated
May 11, 2022
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT05377983
Brief Title
The Effect of Lavender Oil Inhalation on Pain, Anxiety and Sleep Quality After Coronary Artery Bypass Graft
Official Title
The Effect of Lavender Oil Inhalation on Pain, Anxiety and Sleep Quality After Coronary Artery Bypass Graft: a Randomized Controlled Trial Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
August 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study is a non-drug clinical, randomized controlled study, and will be conducted in the Cardiovascular Surgery Clinic of Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi associated to Istanbul Provincial Directorate of Health between December 2020 and December 2021. Criteria to be included in the study were determined as patients who are aged 18 years and over, underwent planned (elective) CABG surgery, whose lavender oil allergy test is negative, who is conscious with place, person and time orientation, who do not have any disability that would make communication difficult, can be communicated in Turkish, were informed to participate in the study and gave written consent. Criteria to be excluded from the study were determined as patients who are allergic to lavender, cosmetics and perfume, have a history of dermatitis, are diagnosed with sleep disorders and use any pharmacological and herbal medicines for these disorders, have sinusitis, upper respiratory tract infection, liver and kidney dysfunction, asthma and Chronic Obstructive Pulmonary Disease (COPD), whose blood pressure is not regulated, have arrhythmia, use controlled analgesia after surgery and cannot be communicated in Turkish. Criteria to be eliminated from the study were determined as patients, who have positive lavender oil allergy test, develop lavender allergy during application, want to leave the study voluntarily, and do not comply with the working process and conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Graft Surgery
Keywords
lavender oil, pain, anxiety, sleep

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
the control group
Arm Type
No Intervention
Arm Description
The control group will only receive routine care.
Intervention Type
Other
Intervention Name(s)
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
Intervention Description
During the hospitalization period after CABG surgery, 2% lavender oil (Lavandula angustifolia) inhalation will be applied to the intervention group three times a day.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
Up to five days
Title
Anxiety level
Description
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.
Time Frame
Up to five days
Title
Sleep quality
Description
Sleep quality will also be evaluated using RCSQ every morning during.
Time Frame
Up to five days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The inclusion criteria for the study were determined as follows: 18 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. Exclusion Criteria: The exclusion criteria for the study were determined as follows: 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. The remaining exclusion criteria were determined as follows: a positive lavender oil allergy test, development of lavender allergy during the study, voluntarily deciding to leave the study, and not complying with the study process and conditions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YEŞIM DIKMEN AYDIN
Phone
+905426238394
Email
yesimdikmen@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YEŞİM DİKMEN AYDIN
Organizational Affiliation
Marmara University Faculty of Health Sciences,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yesim Dikmen Aydin
City
Maltepe
State/Province
İstanbul
ZIP/Postal Code
34854
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YESIM DIKMEN AYDIN
Phone
05426238394
Email
yesimdikmen@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Lavender Oil Inhalation on Pain, Anxiety and Sleep Quality After Coronary Artery Bypass Graft

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