1. Home
  2. Approved trials
  3. » فارسی

Comparing the effects of aromatherapy with Lavender oil and Caria Chamomilla on self-esteem, stress, anxiety and depression, sleep quality and quality of life of the elderly in Shahroud–A clinical trial.

Protocol summary

Summary
Objective: Comparing the effects of aromatherapy with Lavender oil and Caria Chamomilla on self-esteem, stress, anxiety and depression, sleep quality and quality of life of the elderly in Shahroud. Study design: Randomized control trial, duoble blind, two groups (experimental) and one group (control) before and after. Population: Elderly live at home in Shahroud. Inclusion criteria: Minimum age 65 years, the lack of psychiatric disease, no history of anti-anxiety drugs, stress and depression, the ability to communicate verbally, no known respiratory problems such as asthma, independence or any addiction to drugs, tranquilizers. Exclusion criteria: history of asthma and allergies to flowers and plants, smell disorders, history of psychiatric disorders, a history of tensions event in the last 3 months, herbal remedies and alternative medicine use in a week. Sample Size: 183. Interventions: Perfuse 3 drops of lavender essential oil, essential oil chamomile and distilled water on a piece of cotton wool and place it beneath the exterior of their pillows for 30 nights. Main outcome measures (variables): self-esteem, sleep quality, stress, anxiety and depression, quality of life.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201606144281N2
Registration date: 2016-08-20, 1395/05/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-20, 1395/05/30
Registrant information
Name
Azam Hamidzadeh
Name of organization / entity
Shahroud University of Medical Sceince
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
azhamidzadeh@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shahroud University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of aromatherapy with Lavender oil and Caria Chamomilla on self-esteem, stress, anxiety and depression, sleep quality and quality of life of the elderly in Shahroud–A clinical trial.
Public title
Effects of aromatherapy on self-esteem, stress, anxiety and depression, sleep quality and quality of life of the elderly.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Minimum age 65 years; The lack of psychiatric disease; No history of anti-anxiety drugs, stress and depression; The ability to communicate verbally; No known respiratory problems such as asthma; Independence or any addiction to drugs; tranquilizers. Exclusion criteria: History of asthma and allergies to flowers and plants; Smell disorders; History of psychiatric disorders; A history of tensions event in the last 3 months; Herbal remedies and alternative medicine use in a week.
Age
From 65 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 183
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In the present study according to exclusion criteria, participants that distinguish the smell of Lavender oil and Caria Chamomilla will be excluded. So participants will be blind to the type of intervention. Also, due to the time of data collection (before, the first day and one month after the intervention),when there is no smell of Lavender oil and Caria Chamomilla at home, so data collector who is someone other than the principal investigator, will be unaware to the type of intervention. Data analyst will be unaware of groups (experimental and control group) too, therefore, this is a triple-blind study.

Secondary Ids

1

Registry name
ندارد
Secondary trial Id
ندارد
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Shahrood University of Medical Sciences, Hafte-Tir square
City
Shahroud
Postal code
3613773955
Approval date
2016-04-12, 1395/01/24
Ethics committee reference number
SHMU.REC.1395.14

Health conditions studied

1

Description of health condition studied
Self-esteem ,Sleep quality, stress, anxiety, depression , quality of life
ICD-10 code
F88-G47.9-
ICD-10 code description
Other disorders of psychological development-Sleep disorder, unspecifiedAcute stress reaction-Anxiety disorder, unspecified-Mild depressive episode-Person encountering health services in unspecified circumstances

Primary outcomes

1

Description
Self steam
Timepoint
Before and after intervention (The first day and one month after the intervention)
Method of measurement
Questionnaire measured self-esteem scale of Rosenberg

2

Description
Quality of sleep
Timepoint
Before and after intervention (The first day and one month after the intervention)
Method of measurement
Pittsburgh Sleep Quality Iquestionare (PSQI)

Secondary outcomes

1

Description
Stress
Timepoint
Before and after intervention (The first day and one month after the intervention)
Method of measurement
Questionnaire of Stress, Anxiety and Depression-DASS-21

2

Description
Anxitey
Timepoint
Before and after intervention (The first day and one month after the intervention)
Method of measurement
Questionnaire of Stress, Anxiety and Depression-DASS-21

3

Description
Depression
Timepoint
Before and after intervention (The first day and one month after the intervention)
Method of measurement
Questionnaire of Stress, Anxiety and Depression-DASS-21

4

Description
Quality of life
Timepoint
Before and after intervention (The first day and one month after the intervention)
Method of measurement
Quality of life Questionnaire SF12

Intervention groups

1

Description
Intervention group 1: 3 drop of lavender essential oil on the participant’s pillow at night, repeated for 30 day
Category
Other

2

Description
Intervention group 2: 3 drop of Chamomile essential oil on the participant’s pillow at night, repeated for 30 day.
Category
Other

3

Description
control group: 3 drop of Distilled water on the participant’s pillow at night, repeated for 30 day.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Elderly's homes
Full name of responsible person
Azam Hamidzadeh
Street address
Shahrood University of Medical Sciences, Hafte-Tir square
City
Shahroud

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammad Hasam Emamiam
Street address
Shahrood University of Medical Sciences, Hafte-Tir square
City
Shahroud
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, shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Azam Hamidzadeh
Position
Master of Science in Midwifery
Other areas of specialty/work
Street address
Shahrood University of Medical Sciences, Hafte-Tir square
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 5054
Fax
+98 23 3239 4800
Email
azhamidzade@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Hossein Ebrahimi
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Shahrood University of Medical Sciences, Hafte-Tir square
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 3811
Fax
+98 23 3239 4800
Email
h_ebrahimi43@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Azam Hamidzadeh
Position
Master of Midwifery
Other areas of specialty/work
Street address
Shahrood University of Medical Sciences, Hafte-Tir square
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 5054
Fax
+98 23 3239 4800
Email
azhamidzade@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
Loading...