Protocol summary

Summary
The present research aims at examining the effect of inhaling essential oil of orange on the quality of sleep among children with acute lymphoblastic leukemia. The research is a semi-experimental study in which 60 children admitted to the oncology unit in Shafa Hospital affiliated to Jondi-Shapoor Medical Sciences University, Ahvaz, Iran, were studied during 2014 using two test and control groups. The research instruments were demographic information questionnaire and the standard CSHQ questionnaire. The research sample included hospitalized school-aged children with acute lymphoblastic leukemia and with sleep quality score of higher than 41. Intervention in the test group included inhaling essential oil of orange for three days in week and three times each day; similar intervention was used in the control group except that distilled water as placebo instead of essential oil of orange was applied.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014090919102N1
Registration date: 2015-02-04, 1393/11/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-04, 1393/11/15
Registrant information
Name
Masoomeh Noruzi Zamenjani
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+686 113738331
Email address
noruzi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with orange essential oils on sleep quality in the hospitalized school-age children whit ALL
Public title
The effect of aromatherapy with orange essential oils on sleep quality in the hospitalized school-age children whit ALL
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Children that are at school age (6-12 years); Children who receive treatment procedure for ALL; the score of sleep quality more than 41; Children who have no verbal problem; no mental problems; no allergic rhinitis or respiratory problems; no history of hospitalization for psychological illness. Exclusion criteria: during the intervention receive medical treatment outside the usual treatment guidelines; concurrent treatment with other essential oils during the intervention; allergic rhinitis or respiratory problems occurred during the intervention; a crisis or an unpredictable accident occurs.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ahvaz Jundishapour University of Medical Sciences
Street address
Ahvaz Jundishapour University of Medical Sciences, Golestan highway, Ahvaz
City
Ahvaz
Postal code
6135715794
Approval date
2014-02-22, 1392/12/03
Ethics committee reference number
ajums.REC.1393.12

Health conditions studied

1

Description of health condition studied
acute lymphoblastic leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia [ALL]

Primary outcomes

1

Description
sleep quality
Timepoint
Before and after the interventions
Method of measurement
Children Sleep Habits Questionnaire CSHQ

Secondary outcomes

empty

Intervention groups

1

Description
Intervention in the control group included inhaling distilled water as placebo for three days in a week and three times each day ( 10am, 4pm, 10pm ). In control group we measure the score of sleep quality once before intervantion and once after end of intervantions.
Category
Placebo

2

Description
Intervention in the test group included inhaling essential oil of orange for three days in a week and three times each day ( 10am, 4pm, 10pm ). In test group we measure the score of sleep quality once before intervantion and once after end of intervantions.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
H. Alijani Renani
Street address
Ahvaz Jundishapour University of Medical Sciences, Golestan highway, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr Koorush Zare
Street address
Ahvaz Jundishapour University of Medical Sciences, Golestan highway, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapour 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
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
masoomeh noruzi zamengani
Position
Graduate student
Other areas of specialty/work
Street address
Ahvaz Jundishapour University of Medical Sciences, Golestan highway, Ahvaz
City
ahvaz
Postal code
Phone
+98 61 1373 8383
Fax
Email
masoomehnoruzi@gmail.comnoruzi.m@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
H. Alijani Renani
Position
Master of Nursing
Other areas of specialty/work
Street address
Ahvaz Jundishapour University of Medical Sciences, Golestan highway, Ahvaz
City
ahvaz
Postal code
Phone
+98 61 1373 8383
Fax
Email
aLIJANI-H@AJUMS.AC.IRnoruzi.m2AJUMS.AC.IR
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
masoomeh noruzi zamenjani
Position
Graduate Student
Other areas of specialty/work
Street address
Ahvaz Jundishapour University of Medical Sciences, Golestan highway, Ahvaz
City
Ahvaz
Postal code
Phone
Fax
Email
masoomehnoruzi@gmail.commasoomehnoruzi@yahoo.comnoruzi.m@ajums.ac.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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