Protocol summary

Summary
The aim of this study was to evaluate the effect of relaxation training on the pain after surgery in children admitted to the surgical units of Shiraz University of Medical Sciences in 1393-94. samples included 104 eight to twelve year old children who underwent surgery and were randomly divided into two groups of control ) and intervention Used tools included demographic characteristics questionnaire and a pain rating scale. In addition to routine care, the children in the intervention group were trained by Benson relaxation techniques during two sessions, each session 20 minutes with an interval of 4 hours a day before the operation. The control group received routine care of the unit. The pain score of the child was measured in both groups, before the operation, one hour after intervention and twelve hours after intervention.outcom of study was pain.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016021526572N1
Registration date: 2016-08-02, 1395/05/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-08-02, 1395/05/12
Registrant information
Name
Fahimeh Safizadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 4233 3964
Email address
stud3071903261@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2015-05-18, 1394/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Relaxation Training on the Pain after Surgery in 8-12 year old Children Admitted to the Surgical Units of Shiraz University of Medical Sciences in 1393-94
Public title
The effect of relaxation on the pain after surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included: 8-12 years old children; signing of informed consent by parents; lack of a clear mental retardation and mental health problems in parents and children; child is literate; no history of surgery lack of vision and hearing problems in the child; and Exclusion criteria: the reluctance of parents to continue to collaborate in this research and the presence of a disease; or an acute problem that prevents the continuation of cooperation of the child were the exclusion criteria
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 104
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
Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand boulevard.,
City
Shiraz
Postal code
71348-14336
Approval date
2015-02-16, 1393/11/27
Ethics committee reference number
ct-9371-7381

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain

Primary outcomes

1

Description
pain
Timepoint
before the intervention, one hour after intervention and twelve hours after intervention
Method of measurement
Visual Analouge Scale

Secondary outcomes

empty

Intervention groups

1

Description
The children in the intervention group, in addition to routine care which includes analgesics (a dose of 10 mg/kg Apotel and 0.1 mg/kg Petedin) if required, were introduced to the relaxation method that was trained individually during 2 sessions, each session 20 minutes, with an interval of 4 hours a day before surgery along with listening to a CD in which the procedure was explained by the researcher and after each session to ensure the child's learning, 10 minutes for questions and answers was considered. The intervention by the child himself and in the presence of the researcher was conducted for 20 minutes,. an hour later from entering the patient to the unit and the pain score of the child was measured before intervention, one hour after intervention and twelve hours after intervention Then its impact was measured on the score of the severity of his pain in three above phases
Category
Other

2

Description
Control group routine care which includes analgesics (a dose of 10 mg/kg Apotel and 0.1 mg/kg Petedin) if required
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Nemazee hospital
Full name of responsible person
Nooshin Beheshti poor, Instructor of Pediatric Department(Advisor)
Street address
Nemazee squre, Zand ave., Shiraz
City
Shiraz

2

Recruitment center
Name of recruitment center
Mother and Child hospital
Full name of responsible person
Nooshin Bbeheshti poorh
Street address
First Gulshan Town, Gateway Qur'an
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr.Seyed Basir Hashemi
Street address
Zand ave.Central Building Shiraz University of Medical Sciences,zand ave
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Science
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
Shiraz Univrsity Medical sciences
Full name of responsible person
Nooshin Behshti poor
Position
Instructor of pediatric Departmant/ nursing graduate
Other areas of specialty/work
Street address
Shiraz, Nemazee squre, School of Nursing and Midwifery.
City
Shiraz
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
Email
Sdighmontasri@yahoo.com Fahimesafizade67@gmail.com
Web page address
Nurs-Midwif.sums.ac

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nooshin Beeshtipoor
Position
Instructot of Pediatrics Department/ nursing graduate
Other areas of specialty/work
Street address
Shiraz, Nemazee squre, School of Nursing and Midwifery
City
Shiraz
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
Email
Fahimesafizad67@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nooshin Beheshtipoor
Position
Instructor of pediatric department, nursing graduate
Other areas of specialty/work
Street address
Hazrat Fatemeh School of Nursing and Midwifery, Nemazee squre, Shiraz
City
Shiraz
Postal code
Phone
00
Fax
Email
Fahimsafizad67@gmail.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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