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Comparison of jackobson relaxation method and Hugo point massage on Vital sign and severity of pain in patients with cholecystectomy

Protocol summary

Summary
Aims: The purpose of this study is to evaluate and compare the impact of the Hugo point massage and Jakobsen relaxation method on vital signs and pain in patients with cholecystectomy and determine the most effective method to reduce pain and improve patients' vital signs of patients for application to bedside nurses in surgery. Study design: this is a clinical trial study and population of study is 75 who underwent laparoscopic cholecystectomy were randomly divided into three groups and Hugo point massage, relaxation would be allocated Jacobson and controls (n = 25 per group).Inclusion criteria: health in the hands, particularly between the fingers, sixty, having higher average pain intensity and rate (intensity of pain 3 or later), the lack of addiction to drugs, a sedative, alcohol and. .. The lack of sensory disorders . Exit criteria: incidence of severe complications after surgery during hospitalization, such as severe bleeding, edema, acute infections, drugs, tranquilizers, alcohol, diabetics. How to do: according to the standard protocols interventions during the three days when the pain is more than 3 on a numeric scale will be done in two groups. Vital signs (systolic and diastolic blood pressure, pulse, respiratory rate) and the pain will be measured before and after each intervention. In the control group baseline and after three days of operation will be measured vital signs and pain. Finally, the results will be compared among the three groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016021126522N1
Registration date: 2016-05-15, 1395/02/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-15, 1395/02/26
Registrant information
Name
MohamadTaher Rezanejad
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 743320509
Email address
mt.rezanejad@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research of Yasuj University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of jackobson relaxation method and Hugo point massage on Vital sign and severity of pain in patients with cholecystectomy
Public title
Jacobson relaxation and Hugo point massage impact on vital signs and pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: is laparoscopic surgery, organ health of the hands, especially the thumb, having a higher average pain severity (based on a numeric scale of pain intensity 3 and uper), do not member of Health care providers, gaining full consciousness after the surgery, not addicted to narcotics, sedatives, alcohol, etc., lack of sensory and motor disorders, lack of hearing impairment, lack of any other physical and mental disorders from recent surgery, no history of use Hugo point massage and relaxation Jacobson, lack of chronic pain in other parts of the body, such as migraine, low back pain and so on. Exclusion criteria: severe post-operative complications during hospitalization, such as severe bleeding, edema, acute infections, need more care and transferred to the intensive care unit after surgery, use illegal drugs (except substances that are part of the routine management patient (eg, petedine)), sedatives, alcohol, diabetes, patient dissatisfaction and lack of access to appropriate conditions to continue research ..
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Sciences
Street address
Ethics Committee, Deputy of Research and Technology,Yasuj University of Medical Sciences, Jhad Square
City
Yasuj
Postal code
Approval date
2016-02-08, 1394/11/19
Ethics committee reference number
ir.yums.REC.1394.143

Health conditions studied

1

Description of health condition studied
Cholecystectomy
ICD-10 code
K81.0
ICD-10 code description
Acute cholecystitis

Primary outcomes

1

Description
Pain and vital signs
Timepoint
3 days
Method of measurement
Numerical Scale of pain (NRS) and the vital sign form

Secondary outcomes

1

Description
Reducing pain and improving vital signs
Timepoint
3 days
Method of measurement
The numeric scale of pain and vital sign form

Intervention groups

1

Description
The samples Based on a random table, randomly assigned to experimental groups Hugo point massage, relaxation Jacobson and will be the control group. The number of samples for each group, 25 patients and in total, 75 people will be studied. For each of them about how to do research, and the aim of study, then Informed consent of the patient Will be taken and Will ensure .that the above-mentioned method, there is no harm and Will not disruptions in the process of his care. In this study use demographic questionnaire and standardized numerical pain scale (10-0) for collect information. To check vital signs, the patient's vital signs before and after intervention data will be checked and entry to form. Therefore, the normal respiratory rate of 12 to 20, less than 12 Bradypnea and over 20 will be considered tachypnea.Use phygmomanometer to measure blood pressure of patients. if systolic pressure ranging from 140 to 110 mm Hg and diastolic blood pressure 90-80 mm Hg is considered normal. Palpating the patient's pulse rate with the help of over a minute to be counted and considered normal in the 60-100 range and fewer than 60 bradycardia and tachycardia in the top 100 will be considered. The intervention will continue for three days. And until the patients in the hospital and after discharge interventions in the hospital until three days interventions will be done in the home environment. Protocol Hugo point massage: massage of the people will be asked to put in the required position. So researchers will be facing. when the pain on the patient more than 3 score on a numerical pain scale a researcher put his his thumb on right hand of patient and use small bag of ice for pressure on the patient's right hand (hugo point). To prevent discomfort, pressure for deep and back - strength beyond that point forward Hugo and as far as change in nail color will be applied researcher. This procedure repeat three times, so repeated then people explain their pain on a numerical rating scale to determine pain. To search for Suitable of time and its effectiveness of procedure will asked DeQi emotions collection including feeling of heat, numbness, numbness, pain, heaviness and relaxation. Jacobson relaxation protocol: in this group relaxation techniques Jacobson (progressive muscle relaxation and deep breathing) will be used. 6 relaxation sessions over the three days, each session for 30 minutes for patients in the experimental group will be done. the data from the forms and numerical pain scale observation and examination, will be extracted. Educational program in the first session, including progressive relaxation technique for practical steps will be. The relaxation will be monitored by patients. Patients will be asked every single muscle in relaxation of the muscles of the foot and facial muscles, including 16muscles, the first contract and then relax. Patients his muscles twitched and then counted by counting the number 5 to number 10 will loose. The same steps as for the feet and legs, thighs, abdomen, chest, buttocks, hands and forearms, arms, shoulders, neck, forehead, tongue and jaw, eyes and face will repeat until you feel Shell has integrated their entire body. During the relaxation time patients will take a deep breath. Selection mode to relaxation mode is lying. In subsequent meetings and relaxation process will be explained to the patient by the investigator and the patient's description of relaxation researcher to researcher will run under. Control: There will be no intervention in the control group. Patients in the usual care group received and it will be completed only by means of research. The amount and type of housing by patients before and during the intervention will be compared with each other in the checklist.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
shahid beheshti hospital of yasuj city
Full name of responsible person
Street address
City
yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research and Technology of yasuj University of medical science.
Full name of responsible person
shahla najafi
Street address
Yasuj- Street of shahid Galilee - School of Nursing and Midwifery
City
yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology of yasuj 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
School of Nursing and Midwifery of Yasouj
Full name of responsible person
shahla najafi
Position
coach
Other areas of specialty/work
Street address
Yasvj- Street of shahid jalil - School of Nursing and Midwifery
City
yasuj
Postal code
Phone
+98 917 341 2047
Fax
Email
shahla88@gmail.comrezanejad2014@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery of Yasouj
Full name of responsible person
dr.ardeshir afrasiabifar
Position
Nursing Ph.D.
Other areas of specialty/work
Street address
Yasuj- Street shahid jalil - School of Nursing and Midwifery
City
yasuj
Postal code
Phone
+98 917 341 1267
Fax
Email
afrasiabifar@yahoo.com
Web page address

Person responsible for updating data

Contact

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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