This is a clinical single blind trial study. The purpose of this study is to evaluate the effect of acupressure on pain after tonsillectomy in children. The research population consisted of 3 to 12 years-old children undergoing tansillectomy surgery referring to Amiralmomenin Medical Center of Rasht. The number of samples is 48 subjects for each group. The inclusion criteria of the study include: children aged 3 to 12 years old undergoing tansillectomy admitted to the surgery department of Amiralmomenin Medical Center of Rasht. The data gathering tool in this study is a questionnaire for personal information, a form for recording the amount of analgesics drugs use and Ocher pain scale. In this study, acupressure intervention will be performed in three stages (one hour after surgery, 2 to 4 hours and 6 to 8 hours after surgery). The pain in all three groups of children before and after each of the three intervention stages Will be measured and recorded. Children undergoing tansillectomy by random block method are divided into three groups of intervention, placebo and control. In the intervention group, acupressure will apply on the Hegu, Neiting and Zusanli acupoints. At the end of the intervention, the childrens's pain are recorded using the Ocher tool. In the placebo group, the pressure will apply on the same acupoints, with the difference that the applied pressure will be very superficial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100836651N1
Registration date:2017-10-13, 1396/07/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-13, 1396/07/21
Registrant information
Name
Yasaman Yaghobi
Name of organization / entity
Guilan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 6046
Email address
yasamanyaghobi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey effect of acupressure on level of post tonsillectomy pain in children
Public title
Survey effect of acupressure on level of post tonsillectomy pain in children
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria: children aged 3 to 12 years old undergoing tansillectomy; the exclusion criterion: severe postoperative pain that will discourage the child from participating in this study.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University Of Medical Sciences Ethics Committee
Street address
Deputy of Research and Technology Of University Of Guilan, Iran Radiator Building, Imam Khomeini Blv, Rasht
City
Rasht
Postal code
4193893345
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.GUMS.REC.1396.229
Health conditions studied
1
Description of health condition studied
post tonsillectomy pain
ICD-10 code
R07.0
ICD-10 code description
Pain in throat
Primary outcomes
1
Description
post tonsillectomy pain
Timepoint
The pain in all three groups of children before and after each of the three intervention stages Will be measured and recorded.
Method of measurement
Osher pain scale
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, acupressure will apply on the Hegu, Neiting and Zusanli acupoints. At the end of the intervention, the children's pain will be recorded using the Ocher pain scale. Acupressure intervention will be performed in three stages (one hour after surgery, 2 to 4 hours and 6 to 8 hours after surgery).
Category
Treatment - Other
2
Description
In the placebo group, the pressure will apply on the same acupoints of intervention group, with the difference that the applied pressure will be very superficial. At the end of the intervention, the children's pain will be recorded using the Ocher pain scale. Acupressure intervention in placebo group will be performed in three stages (one hour after surgery, 2 to 4 hours and 6 to 8 hours after surgery) similar to intervention group.
Category
Treatment - Other
3
Description
In the control group, usual care will be provide based on the principles of the surgery department. At the end of the intervention, the children's pain will be recorded using the Ocher pain scale.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Educatinal and Remedial Center
Full name of responsible person
Somaye Pouy
Street address
Hamidian Town, Yakhsazi Square, Rasht, Guilan
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Doctor Shadman Nemati
Street address
Contact details: Guilan University Of Medical Sciences, Iran Radiator Building, Imam Khomeini Blv, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University Of Medical Sciences
Full name of responsible person
Somaye Pouy
Position
Bachelor's Degree in Nursing
Other areas of specialty/work
Street address
Yakhsazi Square, Hamidian Town, Rasht
City
Rasht
Postal code
Phone
+98 135507807
Fax
Email
somayepouy@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Doctor Yasaman Yaghobi
Position
PH.D in Nursing
Other areas of specialty/work
Street address
Shahid Beheshti Nursing and Midwifery Faculty, Yakhsazi Square, Rasht
City
Rasht
Postal code
Phone
+98 13 3355 6046
Fax
Email
yasamanyaghobi@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Somaye Pouy
Position
Bachelor's Degree in Nursing
Other areas of specialty/work
Street address
Yakhsazi Square, Hamidian Town, Rasht
City
Rasht
Postal code
Phone
+98 135507807
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)