Introduction: The major of children before surgery experience significant anxiety in the preoperative period. The aim of this study is to investigate effect of acupressure in reducing preoperative anxiety in school age children. Methods: The sample is included of 80 subjects (aged 9-12 years) who have to undergo elective surgery. None of the children have any reported developmental delays. Children are randomly assigned to: the acupressure group (N = 40) and Control group (N = 40). Anxiety in the preoperative period is measured by using the State-Trait Anxiety Inventory. Interventions in this study will be delivered using an acupressure-bead which will be attached to a self-adhesive tape that secure the bead in place and create continuous standardized pressure of 1.3 psi as measured by a tonometer. In the experimental group the bead is stuck to the Ying Tang point (eyebrows mid-point) and in the sham group it is stuck to the sham point outside the eyebrows line. Half an hour later, Anxiety Inventory for Children is filled out by the children again. Anxiety will be assessed at baseline and before entrance to the operating room. In order to prevent any possible bias, all participants were informed that the aim of this study is to determine “which acupoint on the forehead is more effective in reducing preoperative anxiety”.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904071788N3
Registration date:2010-11-16, 1389/08/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-16, 1389/08/25
Registrant information
Name
Leili Borimnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6150 4212
Email address
borimnej@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical sciences
Expected recruitment start date
2010-04-04, 1389/01/15
Expected recruitment end date
2010-09-20, 1389/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Acupressure on preoperative anxiety in school aged children
Public title
Evaluation of efficacy of acupressure on preoperative anxiety in school aged children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Children between the ages of 8 and 11 who receive general anesthesia for elective surgery. Exclusion criteria: children who have any reported developmental delays. History of using accupuncture or acupressure.
Age
From 8 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Nursing and midwifery school, Iran University of Medical Sciences
Street address
Yasemi Street
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
1603081
Health conditions studied
1
Description of health condition studied
Anexity
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Decrease in anxiety
Timepoint
before surgery
Method of measurement
Sepilberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: using an acupressure-bead which will be attached to a self-adhesive tape that secure the bead in place and create continuous standardized pressure of 1.3 psi as measured by a tonometer.
Category
Treatment - Devices
2
Description
control group: the same adhesive apply on external orbital
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Aliasghar Hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Hashemi Nejad Medical centre
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran university of medical sciences
Full name of responsible person
Seide Fatemeh Haghdoost Osquee
Street address
Nursing and midwifery school, Yasemi street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Iran university of Medical sciences
Full name of responsible person
Negar Arbabi
Position
student, Master of science in Nursing
Other areas of specialty/work
Street address
Yasemi street
City
Tehran
Postal code
Phone
+98 21 8247 1710
Fax
Email
borimnej@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran university of Medical sciences
Full name of responsible person
Leili borimnejad
Position
Assistant professor
Other areas of specialty/work
Street address
pediatric Department, nursing and midwifry school, Yasemi street
City
Tehran
Postal code
Phone
+98 21 8247 1711
Fax
Email
borimnej@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)