Protocol summary

Summary
This study is a non-randomized clinical trial. The aim of this study is to determine the effect of aromatherapy with Damask rose on pain and anxiety in elderly individuals undergoing knee joint replacement surgery (total knee arthroplasty).The study population are women and men aged over 60 years who have undergoing knee replacement surgery. The sampling is done continuously available. target sample size is 80 and trial recruitment centers are Moheb and Safa hospitals. inclusion criterias are no history of asthma and allergies, lack of sensitivity to Damask rose, patient's ability to self-reporting, lack of mental disorders (psychosis, dementia, delirium) that will be measured by abbreviated mental test score (AMTs), age over 60 years, no alcohol and substance abuse, healthy sense of smell (olfactory test +), no history of migraine and chronic headache and the ability to count numbers. Exclusion criterias are: lack of willingness to continue cooperation, respiratory allergy symptoms during the study, critically ill patient during the study, surgical wound infection, dislocation of the implant and the need for reoperation, patients who are hospitalized in the ICU for more than 24 hours after surgery.Patients in the intervention group will receive 4 periods of inhalation aromatherapy with Damask rose. Duration of Each period will be one or two minuets. Distance between each period is 30 minutes. The whole intervention will be done in 2 hours. Patient in control group will receive distilled water instead of Damask rose. Before the first intervention demographic form, ATMs questioner and pretest for pain and anxiety will be completed. immediately after the fourth intervention pain and anxiety will be evaluated by posttest.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017030832950N1
Registration date: 2017-04-15, 1396/01/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-15, 1396/01/26
Registrant information
Name
Parvaneh Samady Kia
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4467 1769
Email address
samadikia.p@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research & Technology-Iran University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with Damask rose on pain and anxiety in elderly individuals undergoing knee joint replacement surgery (total knee arthroplasty)
Public title
The effect of aromatherapy on pain and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: no history of asthma and allergies, lack of sensitivity to Damask rose, patient's ability to self-reporting, lack of mental disorders (psychosis, dementia, delirium) that will be measured by abbreviated mental test score (AMTs), age over 60 years, no alcohol and substance abuse, being healthy sense of smell (olfactory test +), no history of migraine and chronic headache and the ability to count numbers. Exclusion criteria: lack of willingness to continue cooperation, respiratory allergy symptoms during the study, critically ill patient during the study, surgical wound infection, dislocation of the implant and the need for reoperation, patients who are hospitalized in the ICU for more than 24 hours after surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, between the intersection of Chamran and Sheikh fazl o lah, Hemat highway
City
Tehran
Postal code
1449614535
Approval date
2016-06-29, 1395/04/09
Ethics committee reference number
IR.IUMS.REC.1395.9411580004

Health conditions studied

1

Description of health condition studied
Knee joint replacement
ICD-10 code
M17
ICD-10 code description
arthrosis of knee

Primary outcomes

1

Description
pain
Timepoint
Before the first intervention and Immediately after the fourth intervention
Method of measurement
Visual Analoge Scale

Secondary outcomes

1

Description
anxiety
Timepoint
Before the first intervention and Immediately after the fourth intervention
Method of measurement
Visual Analoge Scale-Anxiety

Intervention groups

1

Description
The intevention group (Aromatherapy with Rose): 3 to 4 drops of essential oil of Rose are poured on a 10×10 gauze pad and the pad is plased inside a zippere plastic bag. Then the patient is asked to inhale the bag for a minute. This intervention is done four times. the distance between each session is 30 minutes. The intervention is done in 2 hours.
Category
Treatment - Drugs

2

Description
The control group (Receiving placebo): 5 ml of distilled water are poured on a 10×10 gauze pad and the pad is plased inside a zippere plastic bag. Then the patient is asked to inhale the bag for a minute. This intervention is done four times. the distance between each session is 30 minutes. The whole process is done in 2 hours.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Moheb Mehr Hospetal
Full name of responsible person
Fateme Khani
Street address
Khalilzadeh st, Vali asr st, vanak sq
City
Tehran

2

Recruitment center
Name of recruitment center
Shafa Yahyaeian Orthopedics Hospital
Full name of responsible person
Atefe Dastory
Street address
Shafa Yahyaeian Orthopedics Hospital, Mojahedin Islam Ave. Shohada Sq. Baharestan Sq. Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research & Technology-Iran University of Medical Sciences
Full name of responsible person
Doctor Morteza Naserbakht
Street address
Iran University of Medical Sciences, 5th Floor, between intersection of Chamran and Sheikh fazl o lah, Hemat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research & Technology-Iran 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
Nursing school, Iran University of Medical Sciences
Full name of responsible person
Faridah Bastani
Position
PHD-Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rasheed Yassami street, Vali Asr street
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
bastani.f@iums.ac.irfaridehbastani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing school, Iran University of Medical Sciences
Full name of responsible person
Farideh Bastani
Position
PHD-Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rasheed Yassami street, Vali Asr street
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
bastani.f@iums.ac.irfaridehbastani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing school, Iran University of Medical Sciences
Full name of responsible person
Parvaneh Samady kia
Position
Master student of Geriatric Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rasheed Yassami street, Vali Asr street
City
Tehran
Postal code
1996713883
Phone
+98 21 4467 1769
Fax
Email
samadikia.p@tak.iums.ac.irparvanekia@yahoo.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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