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Effect of Self-Care education on controling of pain and side effects of tonsillectomy in children.

Protocol summary

Summary
The main purpose of this quasi-experimental study is determining the effect of self-care education on the control of pain and Complications. Inclusion criteria: children are between 6 to 15 years and parent participating in the study should be able to read and write. Children that admitted to hospital for a tonsillectomy in Hamedan, constitute the study population. The study sample comprised 68 children with a parent who will be randomly divided into two groups, control and case. Intervention: every case group child will be teached self care education for 30 minutes at the night before surgery. After that, the training booklet with a checklist will be gave to them . Within three days after discharge,the Probabilistic questions of case group will be answered during phone calls .control group will be gave just checklists. Outcome: A week later, Cheklists of both groups will be gathered and intensity of pain and complications after tonsillectomy such as nausea, vomiting, difficulty of swallowing, decreased fluid intake, sleep disorders, bleeding, constipation and Behavioral changes, will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013022512609N1
Registration date: 2013-04-20, 1392/01/31
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-04-20, 1392/01/31
Registrant information
Name
Saeide Almasi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7730 9336
Email address
s.almasi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences.
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Self-Care education on controling of pain and side effects of tonsillectomy in children.
Public title
The effect of self-care education on pain after tonsillectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:children are between 6-15 years; The child should not have previous disease or chronic pain; There should not be any history of tonsillectomy in another child in the family; The parent participating in the study should be able to read and write.
Age
From 6 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
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
Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmide st, Hamadan
City
Hamadan
Postal code
65178
Approval date
2013-02-14, 1391/11/26
Ethics committee reference number
16/35/9/4019 /پ/د

Health conditions studied

1

Description of health condition studied
tonsillectomy
ICD-10 code
J35.0 , J3
ICD-10 code description
chronic tonsillitis, hypertrophy of tonsils

Primary outcomes

1

Description
pain
Timepoint
3 day after discharge
Method of measurement
Numeric Rating Scale and Wong-Baker

2

Description
fever
Timepoint
3 day after discharge
Method of measurement
Celsius

3

Description
nausea
Timepoint
3 day after discharge
Method of measurement
a five item likert scale

4

Description
vomiting
Timepoint
3 day after discharge
Method of measurement
a five item likert scale

Secondary outcomes

1

Description
Behavioral changes
Timepoint
3 day after discharge
Method of measurement
a five item likert scale

Intervention groups

1

Description
Case group: Parent and child will be participated in self care education Session at the night before surgery. Self care education will be presented at the bedside and will be takes for 30 minutes. After that, with a checklist, the training booklet include teaching aboute the tonsillectomy, pain controle and analgesics administration as the Aruond the clock, food, activity, common complications after tonsillectomy such as bleeding, nausea, vomiting, fever, Behavioral changes ,cares and follow up and visit will be gave to them . Within three days after discharge,the Probabilistic questions of case group will be answered during phone calls. A week later, Cheklists will be gathered.
Category
Behavior

2

Description
Control group: No intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Street address
City
Hamadan

2

Recruitment center
Name of recruitment center
Bouali Hospital
Full name of responsible person
Street address
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vic-Chancellor for research, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Tavilani
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Ave, Hamedan
City
Hamadan
Grant name
از محل یک درصد بودجه طرح های تحقیقاتی دانشگاه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-Chancellor for research, Hamedan 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
Hamadan University of Medical Sciences
Full name of responsible person
Saeide Almasi
Position
MSC student of nursing
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Ave, Hamedan
City
Hamadan
Postal code
Phone
+98 21 7730 9336
Fax
Email
s.almasi@umsha.ac.ir s.almasi90@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Fateme Cheraghi
Position
phd in nursing
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Hamedan University of Medical Sciences, Shahid Fahmideh Ave, Hamedan
City
Hamadan
Postal code
Phone
+98 81 1838 0527
Fax
Email
f_cheraghi@umsha.ac.ir f_cheraghi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Saeide Almasi
Position
MSC student of nursing
Other areas of specialty/work
Street address
Faculty of nursing and midwifery, Hamedan University of Medical Sciences, Shahid Fahmideh Ave, Hamedan
City
Hamadan
Postal code
Phone
00
Fax
Email
s.almasi@umsha.ac.ir s.almasi90@yahoo.com
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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