Determining the effect of lavender inhalation aromatherapy on pain, anxiety and sleep quality after orthopedic surgery
Design
Clinical trial with control group, with parallel, randomized groups, on 80 patients.Random allocation software is used for randomization.
Settings and conduct
Patients admitted to orthopedic, trauma one and two wards of Ayatollah Kashani hospitals are admitted to the study on the second day after surgery and then are randomly assigned to the experimental and control groups. Inhalation aromatherapy intervention is performed for the intervention group. In this study, blinding is not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 years and older
Be interested in participating in research
Elective and non-emergency surgery
Patients with upper and lower limb fractures who have undergone surgery
Exclusion criteria:
History of lavender allergy (dermal or inhalation)
Covid 19 disease based on PCR test results
Have a history of allergic rhinitis, eczema or known respiratory problems such as asthma
Do not be addicted to drugs
Intervention groups
The intervention group includes patients undergoing orthopedic surgery who will undergo aromatherapy with lavender, so that the samples participating in the study will undergo aromatherapy with lavender essential oil for 2 days and nights at 10 am and 6 pm. Thus, the researcher drops 3 drops of lavender essential oil produced by Barij Company with a dropper on a sterile cloth 10 cm by 10 cm and connects it to the collar of the research unit at a distance of 30 cm from the nose. The patient is then asked to breathe normally for 30 minutes.
The comparison group includes patients after orthopedic surgery who will receive routine treatments and care.
Main outcome variables
the pain; Anxiety; Sleep quality of patients undergoing orthopedic surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111002007692N3
Registration date:2021-12-10, 1400/09/19
Registration timing:prospective
Last update:2021-12-10, 1400/09/19
Update count:0
Registration date
2021-12-10, 1400/09/19
Registrant information
Name
tahere momeni
Name of organization / entity
Isfahan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 913 239 0798
Email address
t_momeni@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-20, 1400/10/30
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with Lavender on pain, anxiety and sleep quality after orthopedic surgery
Public title
The effect of aromatherapy with Lavender on pain, anxiety and sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and older
Be interested in participating in research
Positive olfactory test (ability to detect the smell of the desired aromatherapy solution)
Elective and non-emergency surgery
Patients with upper and lower limb fractures who have undergone surgery Community
Exclusion criteria:
History of lavender allergy (dermal or inhalation)
Covid 19 disease based on PCR test results (currently the hospital requires PCR testing for all patients undergoing surgery)
Have a history of allergic rhinitis, eczema or known respiratory problems such as asthma
Having a cold or any other condition that affects a person's ability to smell.
Do not be addicted to drugs
Using other methods of reducing stress, including progressive muscle relaxation, music therapy, etc.
Smoking
Use of specific medication for psychiatric illness
Simultaneous collaboration in another similar study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization with size of 4.
Randomization unit: individual.
Randomization tool: Random allocation software.
Random chain concealment is by placing patient codes in opaque envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs -Medical University of Isfahan
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-12-23, 1399/10/03
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.628
Health conditions studied
1
Description of health condition studied
Fracture of upper limb, level unspecified
ICD-10 code
T10
ICD-10 code description
Fracture of upper limb, level unspecified
2
Description of health condition studied
Fracture of lower limb, level unspecified
ICD-10 code
T12
ICD-10 code description
Fracture of lower limb, level unspecified
Primary outcomes
1
Description
Pain score based on linear scale
Timepoint
Immediately before and after each intervention
Method of measurement
American 10-item pain intensity measurement questionnaire Patient Outcomes Pain community
Secondary outcomes
1
Description
Score from the Anxiety Inventory
Timepoint
Immediately before and after the intervention
Method of measurement
spielberger anxiety scale
2
Description
Score from the sleep quality questionnaire
Timepoint
Immediately before and after the intervention
Method of measurement
SMHSQ standard hospital sleep questionnaire
Intervention groups
1
Description
Intervention group: In the experimental group, the samples participating in the study are subjected to aromatherapy with lavender essential oil for 2 days and nights at 10:00 AM and 6:00 PM. Thus, the researcher drops 3 drops of lavender essential oil, produced by Barij Essential Oil Company of Kashan, with a dropper on a sterile cloth measuring 10 cm by 10 cm and attaches it to the collar of the research unit at a distance of 30 cm from the nose. The patient is asked to breathe normally for 30 minutes; their pain is recorded immediately before and after each aromatherapy, and their anxiety and sleep quality are measured immediately before and after the intervention.
Category
N/A
2
Description
Control group: The control group will receive inpatient treatment and routine care, and like the sleep quality test group, their pain and anxiety will be assessed by questionnaires at the same time intervals.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital of Isfahan University of Medical Sciences
Full name of responsible person
Tahere Momeni-Ghaleghasemi
Street address
Isfahan, Ayatollah Kashani Street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
t_momeni@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mansour Siavash
Street address
Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
t_momeni@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahere Momeni-Ghaleghasemi
Position
مربی هیات علمی
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
t_momeni@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahere Momeni-Ghaleghasemi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
t_momeni@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahere Momeni-Ghaleghasemi
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
t_momeni@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available