Comparison of the effect of hand and foot massage by nurse and patient along the severity of pain after abdominal surgery
Design
Sampling is done easy And qualified patients entered the study and then randomly assigned using computer software in one of the groups
1) Massage by nurse, 2) Massage by patient and 3) Control group.
Settings and conduct
After surgery and after entering patients into the department and ensuring complete vigilance (passing at least 6 hours of entering the department ),
Having the criteria for entering and preparing the patient for admission to the massage They will be included in the study if they are required to participate in the study on the basis of entry and exit criteria.
The demographic data of all patients participating in the study, including age, gender, marital status, occupation, educational level and history of massage therapy, will be recorded in the personal information form.
In the group that is given by the massage, the education of the patient and the proportion of the patient with the patient It will also be recorded.
Before the intervention, all patients will be evaluated by a numerical grading scale to measure pain intensity. This tool is a 10-degree scale line in the range of 10-0 In such a way that the zero score, the painless state, and the odds, show the worst pain possible The patient is asked to determine the severity of her pain on the instrument.
Participants/Inclusion and exclusion criteria
Abdominal surgery, Full postoperative alertness, Satisfaction to participate in the research project
Intervention groups
Researcher massage, massage by patients' families
Main outcome variables
Intensity of pain
Number of breaths
Systolic blood pressure
Diastolic blood pressure
Number of pulses
Satisfaction level of massage
Satisfaction with pain control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111224008505N48
Registration date:2019-01-14, 1397/10/24
Registration timing:registered_while_recruiting
Last update:2019-01-14, 1397/10/24
Update count:0
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
Seyed Saeed Najafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1727 7445
Email address
najafisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of hand and foot massages by nurse and concomitant of patient on pain severity in abdominal surgeries
Public title
the effect of hand and foot massages on pain severity in abdominal surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Abdominal surgery (cholecystectomy, appendicitis) with general anesthesia;
Age between 18 and 60 years;
Full vigilance after surgery;
Lack of drug and alcohol addiction;
Not having sensory and motor disorders;
The absence of mental illness (which prevents proper communication and mutual understanding);
Lack of muscular and articular diseases;
Exclusion criteria:
Unwillingness to continue cooperation;
Sensitivity to touch and inability of the individual to tolerate massage;
Known for cardiovascular disease;
Having a wound or burn in the area where the massage is to be done;
Sensitization and skin diseases in the area of the hand that prevent the massage;
History of Massage Therapy;
Patient with diabetes;
laparoscopy;
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Examples of eligible entry criteria will be selected, then by random assignment of a block in the three groups of massage by the researcher, massages will be shared with the patient and the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, measurement and recording of pain severity and doses of pain killer drugs will be done a person who is blinded to the patient allocation groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz, 7th floor, Shiity of Medical Sciencraz Universes, Zand Blvd.,
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-07-31, 1397/05/09
Ethics committee reference number
ir.sums.rec.1397.601
Health conditions studied
1
Description of health condition studied
Severity of surgical pain
ICD-10 code
R10
ICD-10 code description
Abdominal and pelvic pain
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before and 6 hours after surgery
Method of measurement
Numerical grading scale to measure pain severity
Secondary outcomes
1
Description
severity of pain assess by Visual Analogue Scale (VAS)
Timepoint
preoperative and 6 hours after operation
Method of measurement
severity of pain will be measured by a ruler numerated from zero to ten. Accordingly scores of one to three , four to seven, and eight to ten represent mild, moderate and severe pain, respectively.
Intervention groups
1
Description
Intervention group: Massage group by researcher-For 30 minutes,Twice, Before surgery and 6 hours after surgery
Category
Treatment - Other
2
Description
Intervention group: Massage by patients' families-For 30 minutes,Twice, Before surgery and 6 hours after surgery
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals of Shahid Rajaee Gachsaran and Besat Hospital of Gachsaran Oil Company
Full name of responsible person
Ebrahim Ebadi
Street address
Kohkiloyeh and Boyer Ahmad - Gachsaran Blvd. Shahid Tondoogan - Besat Hospital
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7134814336
Phone
+98 74 3222 5712
Email
info@piho.ir
Web page address
http://gch.piho.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ghasemi Yones
Street address
7th floor, Shiraz University of Medical Sciences central building, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
1978_71345
Phone
+98 71 3230 5410
Fax
+98 71 3212 2430
Email
hashemib@sums.ac.ir
Web page address
http://research.sums.ac.ir
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 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
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Saeed Najafi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Namazi Square,Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936 -13119
Phone
+98 71 3647 4254
Email
najafisa@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Saeed Najafi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Namazi Square,Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936 -13119
Phone
+98 71 3647 4254
Email
najafisa@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Saeed Najafi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Namazi Square,Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936 -13119
Phone
+98 71 3647 4254
Email
najafisa@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Thesis dissertation And article
When the data will become available and for how long
Unlimited
To whom data/document is available
Student and supervisor
Under which criteria data/document could be used
Preparing thesis and article
From where data/document is obtainable
Student and supervisor
What processes are involved for a request to access data/document
Official and written permission of student and supervisor