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Comparion of aromatherapy with essential oils of Lavender and Rose on sleep quality in patients undergoing chemotherapy

Protocol summary

Summary
The aim of this study was to "Determine the effect of the aroma of the extract of the bone extract on the quality of sleep in patients undergoing chemotherapy" with available sampling and random allocation in four groups: Veroustos, Golmohammadi, Osnavas and placebo, and one-sided with sample size 30 people will be in each group.Criteria for inclusion in the study include: A lack of stressful events such as near-death or surgery in the last six months, Age range from 18 to 60 years, Having the consent to participate in the study, Do not use the herbal remedy in the past month,Not having allergic rhinitis, asthma, chronic pulmonary disease, sleep disorders and other chronic diseases that affect the sense of smell., Lack of susceptibility to medicinal herbs, Lack of sleeping pills, Have a minimum 3-day course of chemotherapy. Exclusion criteria included: Occurrence of stressful events: close lives, divorces and ... during the study, Unwillingness to continue cooperation in the study, Use sleep Palliative interventions during the study, Symptoms of allergy to the fragrance used, Having pain during the study (indicated by the patient's question. Three drops of the essential oil and in the placebo group, distilled water was washed with napkins from the night after chemotherapy at 10 o'clock in the intervention with 5 deep breaths for 10 minutes at identical intervals by the patient for three consecutive nights and the quality of sleep with a questionnaire Petersburg is measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061134457N1
Registration date: 2017-07-09, 1396/04/18
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-09, 1396/04/18
Registrant information
Name
Shahin Tohidi
Name of organization / entity
lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 916 159 3538
Email address
sh.tohidi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Hamedan University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparion of aromatherapy with essential oils of Lavender and Rose on sleep quality in patients undergoing chemotherapy
Public title
CAM and cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Criteria for inclusion in the study: lack of stressful events such as near-death or surgery in the last six months; age range from 18 to 60 years old; having the consent to participate in the study; do not use the herbal remedy in the past month; not having allergic rhinitis, asthma, chronic pulmonary disease, sleep disorders and other chronic diseases that affect the sense of smell; lack of susceptibility to medicinal herbs' not using sleeping pills; take minimum 3-day course of chemotherapy. Exclusion criteria: occurrence of stressful events: close lives, divorces and ... during the study; unwillingness to continue cooperation in the study; use sleep palliative interventions during the study; symptoms of allergy to the fragrance used; having pain during the study (indicated by the patient's question).
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Shahid Fahmida Boulevard opposite Mellat Park
City
Hamadan
Postal code
Approval date
2017-05-13, 1396/02/23
Ethics committee reference number
IR.UMSHA.REC.1396.107

Health conditions studied

1

Description of health condition studied
Chemotherapy
ICD-10 code
G47
ICD-10 code description
Disorders of initiating and maintaining sleep

Primary outcomes

1

Description
sleep quality
Timepoint
Before and 1-3 nights during the intervention
Method of measurement
Standard sleep quality questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Each day, each of the research samples that had the criteria for entering the study, randomly assigned to the group Golmohammadi =, RL = botox, placebo p = and M combination (Golmohammadi and Stouchetus 3 to 2) respectively To complete the sample size in each group and in the four groups as a whole.) After determining each research unit, the demographic information questionnaire is completed with the patient's interview and his case study. Also, the Pittsburgh Sleep Quality Questionnaire was interviewed by the patient in the morning of the first day Chemotherapy is complete.
Category
Treatment - Other

2

Description
In the placebo group, distilled water was washed by napkins from the night after chemotherapy at 10 o'clock in the evening with 5 deep breaths for 10 minutes at identical intervals by the patient, and disinfected disinfectant napkins in front of the patient's clothing at intervals of 10-15 Connected to the nose at the end of the intervention (three nights of chemotherapy), the Peterburger Sleep Quality Questionnaire is again completed by the patient and interviewed.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Deputy of Research and Technologyو Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Shahid Fahmidah, Hamedan University of Medical Sciences
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Shahid Fahmidah, Hamedan University of Medical Sciences
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan School of Nursing and Midwifery
Full name of responsible person
Shahin Tohidi
Position
Nursing faculty member
Other areas of specialty/work
Street address
Nursing and Midwifery College, Hamadan University of Medical Sciences, Shahid Feyhmah Street
City
Hamedan
Postal code
Phone
+98 81 3838 0572
Fax
Email
sh.tohidi8@chmail.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Shahin Tohidi
Position
MSc
Other areas of specialty/work
Street address
Nursing and Midwifery College, Hamadan University of Medical Sciences, Shahid Feyhmah Street
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
sh.tohidi8@chmail.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sahin Tohidi
Position
Hamedan University of Medical Sciences
Other areas of specialty/work
Street address
Instructor / Master of Nursing
City
Faculty of Midwifery Nursing Hamedan
Postal code
Phone
Fax
Email
sh.tohidi8@chmail.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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