Protocol summary

Study aim
Effect of Auriculotherapy and Aromatherapy on Preoperative Anxiety
Design
The randomized clinical trial, controlled, parallel groups, community-based, sample size: 93
Settings and conduct
Location: Akbar hospital, the children are selected by convenience method in this study and then are randomly divided into three groups of aromatherapy, auriculotherapy and control. At first, children's anxiety levels in the three groups are determined by the researcher and then they are placed in the auriculotherapy group and aromatherapy group and control group. 30 minutes after the intervention and before the child is transferred to the operating room, the anxiety level is again measured. The control group receives the routine program. The level of anxiety in the control group is determined 30 minutes later and before being transferred to the operating room. .
Participants/Inclusion and exclusion criteria
Criteria for entering the study: Age of 12-6 years, candidate for minor surgery with general anesthesia, lack of chronic disease, absence of lesion or rash on the ears, no history of respiratory disease and respiratory sensitivity criteria for existing the study: unwillingness to continue participating in the study, the emergence of any special medical condition
Intervention groups
Acupressure group: in the operation day, seeds are installed for 30 minutes in the Shen Men point, relaxation, trunkolizer and endocrine in the non-dominant ear to cause continuous pressure, and during installation, each one of the seeds is held for 2 minutes on each of the designated points with a finger. The aromatherapy group: they are treated for 20 minutes with five drops of damask rose essential oil of 40% that is threaded on a 10 × 10 cotton thread. Control group: routine actions are performed.
Main outcome variables
Reduce anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170624034737N1
Registration date: 2019-02-05, 1397/11/16
Registration timing: retrospective

Last update: 2019-02-05, 1397/11/16
Update count: 0
Registration date
2019-02-05, 1397/11/16
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 506 7739
Email address
zareia3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Auriculotherapy and Aromatherapy with damask rose essential oil on Preoperative Anxiety in Children
Public title
Effect of Auriculotherapy and Aromatherapy on Anxiety in Children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 12-6 years undergo minor surgery
Exclusion criteria:
History of allergy and respiratory disease in the aroma group History of skin allergy in the auriculothrapy group
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: 93
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation block (n=3) method is used to allocate the individuals to the control and intervention groups. In this case, three blocks were determined with the help of the random numbers table. For each selected number, which was between 0-4, the ABC and if the number was 5 - 9, we write the term BCA and 10 – 14 CAB, together with each other as a string. For example, if the numbers selected are 7, 4, 6, 11, 14 and 3, the terms are: BCA - ABC - BCA - CAB - CAB - ABC. Thus, the first child in Group B (the Aromatherapy) and the second in Group C(Control) and a 3th , 4th in Group A ,5th in Group B and sixth in C and the7th in group B, eighth in Group A and the 9th in Group A and the 10th case in group C Will continue as well as the sample size is sufficient.
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
Deputy of Research and Technology University, Building Qureshi, Daneshgah ُSt, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Approval date
2018-06-02, 1397/03/12
Ethics committee reference number
IR.MUMS.REC.1397.096

Health conditions studied

1

Description of health condition studied
Pre oprative Anxiety in Children
ICD-10 code
F93.0
ICD-10 code description
Separation anxiety disorder of childhood

Primary outcomes

1

Description
Child anxiety
Timepoint
Before and after the intervention, before transfer to surgery room
Method of measurement
Modifed Yale Preoperative Anxiety Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Acupressure group: in the operation day, seeds are installed for 30 minutes in the Shen Men point, relaxation, trunkolizer and endocrine in the non-dominant ear to cause continuous pressure, and during installation, each one of the seeds is held for 2 minutes on each of the designated points with a finger.
Category
Treatment - Devices

2

Description
Intervention group: The aromatherapy group: they are treated for 20 minutes with five drops of damask rose essential oil of 40% that is threaded on a 10 × 10 cotton thread.
Category
Treatment - Drugs

3

Description
Control group: no intervention
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar Children's hospital
Full name of responsible person
Azam Zarei
Street address
Front side Shahid Kaveh 14 Ave, Shahid Kaveh Blevd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177897157
Phone
+98 51 3871 3800
Email
zareia3@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Deputy of Research and Technology University, Building Qureshi, Daneshgah ُSt, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3882 3255
Email
tafaghodim@mums.ac.ir
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
Azam Zarei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Daneshgah St,Ibn-e Sina St, School of Nursing and Midwiferyvd
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3859 1511
Email
zareia3@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Soheila Karbandi
Position
Faculty member of School of Nursing and Midwifery Mashhad
Latest degree
Master
Other areas of specialty/work
Nursing Education; Pediatric Nursing
Street address
Daneshgah St,Ibn-e Sina St, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3859 1511
Email
karbandis@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Azam Zarei
Position
MSc pediatric Nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Daneshgah St,Ibn-e Sina St, School of Nursing and Midwifery
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3859 1511
Email
zareia3@mums.ac.ir

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
Not applicable
Data Dictionary
Not applicable
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