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Assessment the effect of Rosa damascene juice aromatherapy on eldery chronic musculoskeletal pain.

Protocol summary

Summary
The objective of this study is to investigate the effect of rose damascene juice on the elderly’s chronic pain of musculoskeletal. Randomized, placebo-controlled, 60 elderly patients with chronic pain who are members of the retirement centers, three centered, in 1395, a blind. After approving the confirmation from the Ethics Committee and permission from the authorities of the center, researchers will enter to these centers, and then using randomized and selected method, those elderlies who have the entry criteria will be assigned to two groups of rose damascene juice and control. Informed consent will be taken by the researcher form the research units. The patients who are literate, will complete the pain intensity assessment tool with the researcher‘s explanations Otherwise, the researcher will ask and complete the tool and those people whose pain score is at least three will enter the study. Before getting into the job, the pain assessment tools will be completed in two groups. Then in intervention group, instructing of how to work is carried out, This means that three drops of rose juice of Barij Essence will be dropped on linen cloth by researcher and it will be connected to the patient’s wear at a distance of 25 cm, and the research units are required to breathe normally. Then we ask them to explain the procedure. This work will be carried out form 9 pm and 6 am for three weeks. Every week, Tools will be completed on the phone in two groups. The same procedure will be performed in the control group, but instead of rose juice almond oil is used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016071828986N1
Registration date: 2017-01-27, 1395/11/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-27, 1395/11/08
Registrant information
Name
Somaye Anbari
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4421 4377
Email address
anbaris93@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing faculty , Sabzevar University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Assessment the effect of Rosa damascene juice aromatherapy on eldery chronic musculoskeletal pain.
Public title
Effect of Rosa damascene juice on Chronic Musculoskeletal pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Chronic musculoskeletal pain ; A member of the retirement centers; Aged 60 years and above; Not having Alzheimer's disease; Without obstruction and nasal congestion, Lack of sensitivity to smells, Do not use other fragrances throughout the study; No loss of smell ; Not blind; Unable to communicate. Exclusion criteria: Hypersensitivity reactions during intervention; The incidence of acute pain during the study; The death of the elderly
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
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
Sabzevar University of Medical Sciences
Street address
Pardise, Tohid street, Sabzevar
City
Sabzevar
Postal code
Approval date
2016-10-10, 1395/07/19
Ethics committee reference number
ir.medsab.rec.1395.77

Health conditions studied

1

Description of health condition studied
Choronic pain
ICD-10 code
R52.1
ICD-10 code description
Chronic intractable pain

Primary outcomes

1

Description
Chronic musculoskeletal pain
Timepoint
Twice a week on Mondays and Thursdays for three weeks
Method of measurement
The hybrid tools of visual and numerical measurement of pain and the McGill short questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Three drops of rose juice of Barij Essence will be dropped on linen cloth by researcher and it will be connected to the patient’s wear at a distance of 25 cm, and the research units are required to breathe normally . This work will be carried out form 9 pm and 6 am for three weeks. Twice each week, on Mondays and Thursdays, the McGill measures of pain questionnaire will be completed in two groups.
Category
Treatment - Drugs

2

Description
Three drops of Sweet almond oil as a placebo which is bought from Barij Essence will be dropped on linen cloth by researcher and it will be connected to the patient’s wear at a distance of 25 cm, and the research units are required to breathe normally. This work will be carried out form 9 pm and 6 am for three weeks. Twice each week, on Mondays and Thursdays, the McGill measures of pain questionnaire will be completed in two groups.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Retirement Centers
Full name of responsible person
Somaye Anbari
Street address
City
Sabzevar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Sabzevar University of Medical Sciences
Full name of responsible person
Dr Mohammad Mohammadzade
Street address
Pardise, Tohide street, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Sabzevar 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
University of Medical Sciences
Full name of responsible person
Somaieh Anbari
Position
Gerontological Nursing student , Nursing Bachelor
Other areas of specialty/work
Street address
Pardise, Tohid street, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4421 4377
Fax
Email
anbari.s71@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Estaji
Position
Master of Surgery
Other areas of specialty/work
Street address
Pardise, Tohid street , Sabzevar
City
Sabzevar
Postal code
Phone
+98 51444446070
Fax
Email
Z.estaji@ yahoo.com
Web page address
www.medsab.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Somaye Anbari
Position
Gerontological Nursing student, Nursing Bachelor
Other areas of specialty/work
Street address
Pardise, Tohid street, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4421 4377
Fax
Email
anbari.s71@gmail.com
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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