A comparative study of the effects of rose water aromatherapy and lavender aromatherapy on the intensity of pain and fatigue of colorectal cancer patients undergoing chemotherapy
Comparison of the effect of Rose Aromatherapy with Lavender Aromatherapy on the intensity of pain and fatigue of colorectal cancer patients undergoing chemotherapy
Design
It is a randomized cross-over clinical trial that without blinding and randomly using a block method of four, people referring to the above medical centers are equally divided into two test groups A (32 people) and B (32 people)
Settings and conduct
The above project is carried out in Bahar (Shahroud city) and Kausar (Semnan city) hospitals. Aromatherapy will be performed individually by the researcher in separate rooms for the patient.
Participants/Inclusion and exclusion criteria
People with colorectal cancer aged between 18 and 70 years, who are natives of Semnan province and have referred to Kausar hospitals in Semnan city and Bahar hospitals in Shahrood city to receive their first to fifth chemotherapy, were considered as inclusion criteria, and people Those who do not want to participate in the study and are other than the stated cases are considered as the exit criteria.
Intervention groups
First, the mentioned questionnaires will be completed for the people who have the conditions to enter the study. In the following, aromatherapy with rose water for group A patients and aromatherapy with lavender for group B patients will be performed during a patient's chemotherapy session. In the following, the above-mentioned questionnaires will be completed for patients with time intervals of half an hour, one hour and four hours from the start of aromatherapy. Then the intervention is washed out for a week to eliminate the effects of aromatherapy. After that, it will be done for patients in group A (inhalation aromatherapy with lavender) and for patients in group B (inhalation aromatherapy with rose water). Again, the above questionnaires will be completed in the same way as before.
Main outcome variables
Pain, Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200926048842N4
Registration date:2023-07-08, 1402/04/17
Registration timing:prospective
Last update:2023-07-08, 1402/04/17
Update count:0
Registration date
2023-07-08, 1402/04/17
Registrant information
Name
Sajad Salehipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3237 3188
Email address
ssn.shahroud@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-11, 1402/04/20
Expected recruitment end date
2023-10-12, 1402/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effects of rose water aromatherapy and lavender aromatherapy on the intensity of pain and fatigue of colorectal cancer patients undergoing chemotherapy
Public title
Effect of rose and lavender aromatherapy on pain intensity and treatment of colorectal cancer under chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Insensitivity to plants and their extracts according to the person's previous history
Colorectal cancer has been definitively diagnosed by a hematologist and oncologist.
Undergoing the first cycle of chemotherapy up to a maximum of the fifth cycle of chemotherapy
Having a pain intensity score of at least 3 based on the questionnaire (VAS)
No smoking, drugs and alcohol
Not suffering from other known chronic diseases such as heart-pulmonary diseases, blood pressure and diabetes
Not using perfume or cologne before or during the intervention
Not having an olfactory disorder and also having a cold and nasal congestion that should affect the sense of smell
Absence of mental disorders
Not receiving natural painkillers 3 hours before the start or during the intervention
Having a history of surgery in less than 3 months
Having hemoglobin of at least 8gr/dl
Exclusion criteria:
Use of other pain relief methods during the study
Refusal to continue participating in the study
The patient's lack of awareness colorectal cancer
Decreased level of alertness while studying
Occurrence of skin and eye allergies during study
The occurrence of severe physical complications caused by the disease
death of the patient
suffering from diseases characterized by fatigue (multiple sclerosis, fibromyalgia, AIDS, joint rheumatism)
Presence of perceptual disorders related to smell (olfactory hallucinations)
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by the available method. Every patient with colorectal cancer referring to Kausar (Semnan city) and Bahar (Shahroud city) hospitals who meets the inclusion criteria should be included in the study. Then the selected patients are cross-divided into two groups (A, B). In this way, first, envelopes with group names are prepared for the total number of study subjects and randomly arranged and selected by reference and selection of individuals, one of the cards will be identified, which will determine the individual's group. Was. According to random sampling, the research samples will have an equal chance to be selected in two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Headquarters of Semnan University of Medical Sciences and Health Services, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-06-26, 1402/04/05
Ethics committee reference number
R.SEMUMS.REC.1402.065
Health conditions studied
1
Description of health condition studied
Colorectal cancer
ICD-10 code
C19
ICD-10 code description
Malignant neoplasm of rectosigmoid junction
Primary outcomes
1
Description
Pain intensity
Timepoint
It is before the start of the intervention and thirty minutes and one hour and three hours after the intervention.
Method of measurement
The visual scale for measuring pain intensity is a 10 cm ruler, on the left end of which the word no pain is written and on the right end the word the most severe state of pain is written. According to the amount of pain in the last 48 hours, the person puts a mark on the continuum; Then the amount of pain is measured by the researcher using the visual pain intensity measurement scale (VAS) which is standardized for pain measurement. The visual scale for measuring pain intensity from zero to ten is divided as follows: 0-1: (no pain) / 2-3: (little pain) / 4-5: (extreme pain) / 6-7: (pain) very bad)/ 8-9: (maximum pain) and 10 (unbearable pain).
2
Description
Fatigue rate
Timepoint
It is before the start of the intervention and thirty minutes and one hour and three hours after the intervention.
Method of measurement
The questionnaire (MFI) consists of 20 items and 5 subscales of general fatigue (4 questions), physical fatigue (4 questions), decreased activity (4 questions), decreased motivation (4 questions) and mental fatigue (4 questions), which It is used to measure fatigue. The scoring of the questionnaire is on a 5-option Likert scale from 1 = yes, completely true to 5 = no, completely false. Questions number 2, 5, 9, 10, 13, 14, 16, 17, 18, 19 are graded in reverse order and are graded as 5 completely correct to 1 completely incorrect. To get the overall score of the questionnaire, the scores of all items are added together. The total score of each field is 4-20 and the total score of fatigue determined by the sum of the scores of the fields can be between 20-100. A higher score indicates greater fatigue.
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: At first, the demographic information form, and visual pain level (VAS) and fatigue level (MFI) questionnaires will be completed for patients in group A. Then these people will be subjected to inhalation aromatherapy intervention with rose essence in separate rooms individually. The interventionist was present in the chemotherapy department of the mentioned hospitals, and for the participants in this group, during a session of 4:30 hours from the moment of starting the chemotherapy, 5 drops of the essential oil of the rose flower provided by Gulabgiri Kashan Company with He will pour the prepared 1.5% concentration on a piece of cotton and place it on the collar of the patient's clothes at a distance of about 20 cm from the nose. The cotton piece remains in place for 4:30 hours during chemotherapy. Again, the level of pain and fatigue of the patients will be completed based on the mentioned questionnaires in the period of thirty minutes, one hour and three hours from the start of the aromatherapy intervention for this group of patients. Then the intervention is washed out for a week so that the effects of rose water aroma therapy in this group disappear. After that, the visual pain level (VAS) and fatigue level (MFI) questionnaires will be completed again for group A patients. In the following, these people under the intervention of inhalation aroma therapy with lavender essential oil with a concentration of 1.5% prepared by Barij Essential Oil Company of Kashan will pour 5 drops of the above scent on a piece of cotton and put it on the collar of the patient's clothes with about 20 cm meters away from the nose. The cotton piece remains in place for 4:30 hours during chemotherapy. Again, the level of pain and fatigue of the patients will be completed based on the mentioned questionnaires in the period of thirty minutes, one hour and three hours from the start of the aromatherapy intervention for this group of patients.
Category
Rehabilitation
2
Description
The second intervention group: At first, the demographic information form, and visual pain level (VAS) and fatigue level (MFI) questionnaires will be completed for patients in group B. Then these people will be subjected to inhalation aromatherapy intervention with lavender essential oil in separate rooms individually. The interventionist was present in the chemotherapy department of the mentioned hospitals, and for the participants in this group, during a session of 4:30 hours from the moment of the start of chemotherapy, 5 drops of lavender scent, which was provided by Barij Essan Company of Kashan with He will pour the prepared 1.5% concentration on a piece of cotton and place it on the collar of the patient's clothes at a distance of about 20 cm from the nose. The cotton piece remains in place for 4:30 hours during chemotherapy. Again, the level of pain and fatigue of the patients will be completed based on the mentioned questionnaires in the period of thirty minutes, one hour and three hours from the start of the aromatherapy intervention for this group of patients. Then the intervention is washed out for a week so that the effects of lavender aromatherapy in this group disappear. After that, the visual pain level (VAS) and fatigue level (MFI) questionnaires will be completed again for group B patients. In the following, these people under the intervention of inhalation aroma therapy with rose essence with a concentration of 1.5%, prepared by Gulab Giri Kashan Company, will pour 5 drops of the above scent on a piece of cotton and put it on the collar of the patient's clothes with about 20 cm meters away from the nose. The cotton piece remains in place for 4:30 hours during chemotherapy. Again, the level of pain and fatigue of the patients will be completed based on the mentioned questionnaires in the period of thirty minutes, one hour and three hours from the start of the aromatherapy intervention for this group of patients.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan University of Medical Science, Kausar Hospital
Full name of responsible person
Sajad Salehipour
Street address
Kausar educational research and treatment center, Golestan, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Email
kosarhos@semums.ac.ir
2
Recruitment center
Name of recruitment center
Shahrood University of Medical Science, Bahar Hospital
Full name of responsible person
Sajad Salehipour
Street address
Bahar educational research and treatment center, 22 Bahman St, Shahrud
City
Shahroud
Province
Semnan
Postal code
3614773946
Phone
+98 23 3239 5054
Email
info@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mir Mohammad Khani
Street address
Central headquarters of Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Sajad Salehipour
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 19, Alley 12, Lebanon Martyrs Street, Tehran Avenue
City
Shahroud
Province
Semnan
Postal code
3619676483
Phone
+98 23 3237 3188
Email
ssn.shahroud@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sajad Salehipour
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 19, Alley 12, Lebanon Martyrs Street, Tehran Avenue
City
Shahroud
Province
Semnan
Postal code
3619676483
Phone
+98 23 3237 3188
Email
ssn.shahroud@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sajad Salehipour
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 19, Alley 12, Lebanon Martyrs Street, Tehran Avenue
City
Shahroud
Province
Semnan
Postal code
3619676483
Phone
+98 23 3237 3188
Email
ssn.shahroud@yahoo.com
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