The purpose of this study was to evaluate and compare the impact of massage using lavender essence oil, orange essence oil and no oil on fatigue and quality of life sleep in chronic obstructive pulmonary disease patients
Design
The purpose of this study was to evaluate and compare the impact of massage using lavender essence oil, orange essence oil and no oil on fatigue and quality of life in chronic obstructive pulmonary disease. 105 patients were randomly divided into control and 3 intervention groups.
Settings and conduct
Intervention: Massage will be done with the hand thenar and thumb finger with a brief compression, starting from the heel to the fingers, with use of noshad chamomile oil in group one and noshad almond oil in group two and no use of oils in group three for 10 Minutes for every foot. Name of recruitment center: Shahid Modarres Hospital Kashmar
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Having Chronic Obstructive Pulmonary Disease Based On Internal Medicine Recognition 2-Having a Sleep Disorder , According To Pittsburgh Sleep Quality Questionnaire Score (Total Score Higher Than 5) Exclusion Criteria: 1-Non-Use Of Hypnotics And Anti-Anxiety Drugs 2-Lack 0f Respiratory Tract Infection
Intervention groups
Intervention group1: Massage will be done with the hand thenar and thumb Finger, start from the heel to the toes using 3 cc of lavender essence oil for 10 Minutes for every Foot. Intervention group2: Massage will be done with the Hand Thenar and Thumb Finger, start from the heel to the toes with use of 3 cc of orange essence oil for 10 Minutes brief pressure for every Foot. Intervention group 3: Massage will be done with the hand thenar and thumb Finger, start from the heel to the toes without use of oils for 10 Minutes brief pressure for every Foot.
Main outcome variables
Sleep Quality; Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221005056098N1
Registration date:2022-10-23, 1401/08/01
Registration timing:prospective
Last update:2022-10-23, 1401/08/01
Update count:0
Registration date
2022-10-23, 1401/08/01
Registrant information
Name
Reza Mohammadpourhodki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5542 1289
Email address
mohammadpourhr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-16, 1401/08/25
Expected recruitment end date
2023-03-16, 1401/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aromatherapy massage on fatigue and quality of sleep in Chronic Obstructive Pulmonary Disease patients
Public title
Effect of aromatherapy massage on fatigue and quality of sleep in Chronic Obstructive Pulmonary Disease patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having chronic obstructive pulmonary disease
Age 30 to 60 years old
Having healthy feet Ability to tolerate foot massage
Ability to tolerate massage
Exclusion criteria:
Specific disease (diabetes and stroke and asthma)
Use sleeping pills and anti-anxiety drugs
Infection of the respiratory system
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation sequences will be developed using the SPSS software by a statis-
tician to select random permuted blocks (block size of 6). Then, samples were randomly assigned to three groups (aromatherapy massage with Lavender essential oil, aromatherapy massage with Citrus Aurantium essential oil, and control group).
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran
Before the study (before the intervention) and five days after the intervention
Method of measurement
Pittsburgh Sleep Quality Index
2
Description
Fatigue
Timepoint
Before the study (before the intervention) and five days after the intervention
Method of measurement
With Use Of FSS Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group1: Massage will be done with the Hand Thenar and Thumb Finger, start from the heel to the toes using 3 cc of Noshad chamomile oil for 10 Minutes for every Foot.
Category
Treatment - Other
2
Description
Intervention group: Intervention group2: Massage will be done with the Hand Thenar and Thumb Finger, start from the heel to the toes with use of 3 cc of Noshad Almond oil for 10 Minutes brief pressure for every Foot.
Category
Treatment - Other
3
Description
Control group: Intervention group 3: Massage will be done with the Hand Thenar and Thumb Finger, start from the heel to the toes without use of oils for 10 Minutes brief pressure for every Foot.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Reza Mohammadpourhodki
Street address
Shahid Modarres
City
Kashmar
Province
Razavi Khorasan
Postal code
۳۶۱۴۷۷۳۹۴۷
Phone
+98 51 5522 1440
Email
rezamdpoor@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour
Street address
Knowledge and Health City – In the end of Shahid Fakouri Blvd (In front of Fakouri 94) – Mashhad - Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9716591778
Phone
+98 51 5522 1440
Email
rezamdpoor@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Reza Mohammadpourhodki
Position
Educator
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
rezamdpoor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Mohammadpourhodki
Position
Educator
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
rezamdpoor@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Mohammadpourhodki
Position
Educator
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
rezamdpoor@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