Therefore the present study aims to investigate the effect of acupressure on postoperative pain relief in children aged 5 to 12 years old undergoing tonsillectomy at Amir Almomenin Therapeutic Training Center in Rasht.
Design
The present study is a randomized, blinded, sham controlled clinical trial with a parallel group design of 144 children, will be enrolled between June 2018 and September 2018.
Settings and conduct
In this study, children who have inclusion criteria will be randomly assigned into one of three intervention, control and placebo groups. The proper time for intervention will be 1 hour after tonsillectomy, then 2 to 4 hours and 6 to 8 hours after the surgery. In the intervention group, the amount of the child nausea and vomiting will be first measured and recorded, then acupressure on three acupoints will be applied. In the placebo group, pressure will be applied to the same points with the difference that the applied pressure will be very superficial. In the control group only routine care will be provided.
Participants/Inclusion and exclusion criteria
Inclusion criteria of the study included: children aged 5 to 12 years old who were under tonsillectomy and will be admitted to the surgical ward of Amir Almomenin Therapeutic Training Center in Rasht؛ Exclusion criteria of this study included: mental disorders, dermatological damage near acupressure zone, coagulopathy and existence of severe postoperative pain that prevented the child’s ability from participating in this study
Intervention groups
This study have three intervention, control and placebo groups. In the intervention group, acupressure will be applied at three acupoints (acupuncture points) and in the placebo group, the sham acupressure will be applied. In the control group only routine care will be applied.
Main outcome variables
Nausea؛ vomiting.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171008036651N2
Registration date:2018-05-29, 1397/03/08
Registration timing:prospective
Last update:2018-05-29, 1397/03/08
Update count:0
Registration date
2018-05-29, 1397/03/08
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
Expected recruitment start date
2018-06-04, 1397/03/14
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey effect of acupressure on level of nausea and vomiting in hospitalized children undergoing tonsillectomy
Public title
Survey effect of acupressure on level of nausea and vomiting in hospitalized children undergoing tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children aged 5 to 12 years old who will be under tonsillectomy in the Amir Almomenin Therapeutic Training Center in Rasht.
Exclusion criteria:
Mental disorders.
Dermatological damage near acupressure zone.
Coagulopathy
Existence of severe postoperative nausea and vomiting that prevented the child’s ability from participating in this study.
Age
From 5 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done as random blocks allocation. The randomization method will be selected based on the random number table so that the first child examined at the beginning of the work will be assigned in the acupressure group, the second in the control group, the third in the placebo group, the fourth in the acupressure group, and so on. Children and their parents will not be aware unaware of how to allocate to each of the three groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, children, parents, nurses and other health personnel who are in contact with the child will be unaware of the allocation of each of the three groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethica committee of Guilan University of Medical Sciences
Street address
Guilan University Of Medical Sciences, Iran Radiator Building, Imam Khomeini Blv, Rasht
City
Rasht
Province
Guilan
Postal code
3984141469
Approval date
2018-05-11, 1397/02/21
Ethics committee reference number
IR.GUMS.REC.1397.054
Health conditions studied
1
Description of health condition studied
Post tonsillectomy nausea and vomiting.
ICD-10 code
K91.9
ICD-10 code description
Post procedural disorder of digestive system, unspecified
Primary outcomes
1
Description
Nausea and vomiting.
Timepoint
The proper time for intervention is one hour after the operation of the tonsillectomy and then 2 to 4 hours and 6 to 8 hours after the operation.
Method of measurement
The level of nausea and vomiting will be measured using the Baxter Animated Retching Faces (BARF) scale.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the nausea and vomiting level of the child will be first measured and recorded, and on the two sides of the Hego, Neiting and Zuslanli points on both symmetrical limbs, acupressure will be applied. The way to apply pressure is to massage deep and roughly, with the finger of the thirty-sixth marker and to the researcher's point of view and in a clockwise direction, from 3 to 4 kilograms. Each time the pressure period will be two minutes.
Category
Treatment - Other
2
Description
Control group: In the control group without any intervention, the children will be spoken about their feelings around the surgery (the fear of the surgery, the way of behavior of surgery room nurses) and post-surgery experience (existence of pain, lethargy and restlessness) and they also were asked questions about the number of children in family and school.
Category
Treatment - Other
3
Description
Control group: In the placebo group, pressure will be applied on the Hego, Neiting and Zuslanli points, with the exception that the applied pressure will be very superficial.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Medical and Education Center
Full name of responsible person
Somaye Pouy
Street address
Yakhsazi Square, Hamidian Town, Rasht
City
Rasht
Province
Guilan
Postal code
4148835132
Phone
+98 13 3323 8307
Email
somayepouy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Doctor Shadman Nemati
Street address
Guilan University Of Medical Sciences, Iran Radiator Building, Imam Khomeini Blv, Rasht
City
Rasht
Province
Guilan
Postal code
416351873
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
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
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
Guilan University of Medical Sciences
Full name of responsible person
Somaye Pouy
Position
Bachelor's Degree in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Yakhsazi Square, Hamidian Town, Rasht
City
Rasht
Province
Guilan
Postal code
4148835132
Phone
+98 13 3355 5056
Email
somayepouy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Doctor Yasaman Yaghobi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Nursing and Midwifery Faculty, Yakhsazi Square, Rasht
City
Rasht
Province
Guilan
Postal code
4148835132
Phone
+98 13 3355 5056
Email
yasamanyaghobi@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Somaye Pouy
Position
Master student of nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Yakhsazi Square, Hamidian Town, Rasht.
City
Rasht
Province
Guilan
Postal code
4148835132
Phone
+98 13 3355 5056
Email
somayepouy@gmail.com
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
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available