Protocol summary

Study aim
Determining the effect of aromatherapy with peppermint essential oil on the average score of fatigue and anxiety of cancer patients undergoing chemotherapy
Design
Clinical trial with intervention group, control group, double-blind, randomized, on 64 patients.
Settings and conduct
People suffering from cancer undergoing chemotherapy who visit Shahid Jalil Yasouj Hospital during the study and eligible patients are randomly divided into 32 blocks including 2 patients and each of the 2 patients in the random block receives aromatherapy or placebo.Blinding is double-blind, and the doctor, patient, person responsible for data collection, and those who evaluate the outcome are unaware, and only the supervisor of the project knows.
Participants/Inclusion and exclusion criteria
Inclusion criteria: written consent to participate in the research, suffering from cancer as diagnosed by a specialist, 2 weeks have passed since the start of chemotherapy, the ability to read and write and see, having a healthy sense of smell based on the client's statement. Inclusion criteria: having a mental disorder, having a history of migraine, asthma and allergies, using anti-anxiety medication
Intervention groups
intervention group: This group was subjected to aromatherapy with peppermint essential oil prepared by Zardband Company in Tehran, so that intervention was performed on them for 4 sessions for 20 minutes during 4 days. control group: Distilled water was used for this group so that the intervention was carried out on them for 4 sessions for 20 minutes during 4 days.
Main outcome variables
Anxiety, fatigue

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221017056207N1
Registration date: 2024-01-04, 1402/10/14
Registration timing: prospective

Last update: 2024-01-04, 1402/10/14
Update count: 0
Registration date
2024-01-04, 1402/10/14
Registrant information
Name
Akbar aminiparvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3226 5815
Email address
akbaramini1373@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-14, 1402/10/24
Expected recruitment end date
2024-02-13, 1402/11/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of aromatherapy with peppermint essential oil on the average score of fatigue and anxiety of cancer patients undergoing chemotherapy
Public title
Effect of peppermint on fatigue and anxiety of patients undergoing chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having cancer diagnosed by a specialist 2 weeks have passed since the start of chemotherapy Being visually healthy and literate Having a healthy sense of smell based on the client's statement Informed consent to participate in research
Exclusion criteria:
Having mental disorders Having a history of migraines, asthma and allergies Use of anti-anxiety medication
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
They are selected as study samples by random sampling from the list of patients available on the website. For this purpose, the table of random numbers and the two-group block random allocation method are used. In this method, 64 eligible patients are randomly divided into 32 blocks including 2 patients. Then, each of the 2 patients will receive aromatherapy or placebo in a random block, so that 32 patients will be assigned to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The packaging of herbal medicine and placebo is prepared with a label with code A or B. Other specifications on the labels are the same. The doctor, nurse, patient, responsible for data collection and those who evaluate the outcome are unaware of the drug and placebo group. Only the supervisor of the project and the expert responsible for packing the dropper know the contents of the packages or code A or B. Patients are aware that they are either in the herbal medicine group or in the placebo group, but they do not know the type of group they are in.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yasouj University of Medical Sciences
Street address
Motahari Blvd., Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2022-10-12, 1401/07/20
Ethics committee reference number
IR.YUMS.REC.1401.95

Health conditions studied

1

Description of health condition studied
neoplasms
ICD-10 code
C80.9
ICD-10 code description
Malignant neoplasm, primary site unspecified

Primary outcomes

1

Description
Anxiety
Timepoint
Before the intervention and after the intervention
Method of measurement
Spielberger Manifest Anxiety Questionnaire

2

Description
Fatigue
Timepoint
Before the intervention and after the intervention
Method of measurement
Fatigue Questionnaire (cancer patients)

Secondary outcomes

empty

Intervention groups

1

Description
32 people are selected as intervention group. For 4 days, 5 drops of peppermint essential oil (provided by Zardband, Tehran) will be sprinkled with a dropper on a non-absorbable napkin for 20 minutes a day and will be placed at a distance of 20 cm from the subject's nose for 20 minutes. After 4 days, the level of their fatigue and anxiety will be checked using two Spielberger anxiety questionnaires and cancer fatigue scale.
Category
Rehabilitation

2

Description
Control group: 32 people will be selected as the control group. For 4 days and every day for 20 minutes, 5 drops of distilled water will be sprinkled on a non-absorbable tissue with a dropper and placed at a distance of 20 cm from the subject's nose for 20 minutes. After 4 days, the level of their fatigue and anxiety will be checked using Spielberger anxiety questionnaire and cancer fatigue scale.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Jalil Yasouj Hospital
Full name of responsible person
Amin Nazer Mozafari
Street address
Shahid Jalil Hospital، Qorani Blvd، Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7001
Fax
+98 74 3333 7001
Email
jalilhospital@yums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Seyedamin Hosseini Mutlaq
Street address
Vice President of Research and Technology, Headquarters of Yasouj University of Medical Sciences, Shahid Motahari Boulevard
City
Yasooj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
en@yums.ac.ir
Grant name
Yasouj University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Akbar aminiparvar
Position
Master's student in internal surgery
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences, Motahari Blvd, Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7230
Fax
Email
akbaramini1373@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Akbar Aminiparvar
Position
Master s student medical and internal surgery
Latest degree
Bachelor
Other areas of specialty/work
nursing
Street address
Central Headquarters of the University of Medical, Motahari Blvd, Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7571888357
Phone
+98 74 3333 7230
Fax
Email
akbaramini1373@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Akbar Aminiparvar
Position
Master s student medical and internal surgery
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
Central Headquarters of the University of Medical, Motahari Blvd, Yasouj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3337230
Fax
Email
akbaramini1373@gmail.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
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