Protocol summary

Study aim
The aim of this study is compare the effects of compressive massage and ice massage on LI4 and SP6 points on pain after appendectomy.
Design
This study is a randomized, controlled and clinical trial of 90 patients who are referred to the Sajjad Torbat-e Jam Hospital and undergo appendectomy. At first, patients will be assessed for Inclusion criteria and Exclusion criteria. Then patients undergoing appendectomy will undergo general anesthesia and have entry criteria. Before surgery, they are selected by available sampling method and randomly divided into three groups: acupressure (test), ice massage (test) and routine treatment (control).
Settings and conduct
This study is a randomized, controlled and clinical trial of 90 patients who are referred to the Sajjad Torbat-e Jam Hospital and undergo appendectomy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate for appendectomy; resident of Torbat-e Jam city; absence of diabetes; Exclusion criteria: Appendicitis with complication; drug use and drug addiction; skin allergy or scarring at points LI4 and SP6; history of use From acupressure and ice massage.
Intervention groups
In the acupressure group, in addition to routine therapies, the researcher will press the LI4 on the rotary clock for 5 minutes according to the clockwise model, and then apply the same pressure on the opposite side for 5 minutes. And in the first 5 minutes, the same side presses the opposite clockwise, and it repeats the same action on the opposite side, and the intervention takes 20 minutes. At the same time, with the researcher's assistance, a double-sided compression on the SP6 point, this is three centimeters above the inner ankle behind the posterior edge of the Tibia. In the ice massage group, in addition to routine treatments, for them massage will be given for 20 minutes at points LI4 and SP6 with a bag of ice (crushed ice at 3 cm in 3 cm). There is no intervention in the control group and patients will only receive routine treatment.
Main outcome variables
The severity of pain in patients was recorded by researcher in the three groups by a throat once before the onset of the intervention and again immediately after the intervention (immediately, at the end of 20 minutes of intervention) with a 10 degree visual acuity scale.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170921036302N2
Registration date: 2017-12-31, 1396/10/10
Registration timing: retrospective

Last update: 2017-12-31, 1396/10/10
Update count: 0
Registration date
2017-12-31, 1396/10/10
Registrant information
Name
sadigheh Khalili Shomia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8328
Email address
khalilis@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2017-09-05, 1396/06/14
Expected recruitment end date
2017-11-05, 1396/08/14
Actual recruitment start date
2017-09-05, 1396/06/14
Actual recruitment end date
2017-11-05, 1396/08/14
Trial completion date
empty
Scientific title
Comparative study the effect of two methods, compression massage and ice massage in LI4 and SP6 points on pain after appendectomy
Public title
The effect of two methods, compression massage and ice massage in LI4 and SP6 points on pain after appendectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for appendectomy Resident of Torbat-e Jam city absence of diabetes
Exclusion criteria:
Appendicitis with complication Drug use and drug addiction Skin allergy or scarring at points LI4 and SP6 History of use from acupressure and ice massage
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
More than 1 sample in each individual
Number of samples in each individual: 1
One example
Actual sample size reached: 90
More than 1 sample in each individual
Actual sample size in each individual: 1
One example
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are selected in an accessible manner. Then they are randomly divided into three groups (two intervention groups and one control group). In this way, we select 90 small paper forms of both shape and size (in total number of research samples). On 30 ice cards, 30 massage cards and 30 control cards will be written. Then put all the cards in a bag, and every time you shake the bag, each illness has the conditions for entry into the study. He/she takes a card from the bag and, according to the card, enters one of these three groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Collegiate Paradise, Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2017-09-04, 1396/06/13
Ethics committee reference number
ir.medsab.rec.1396.53

Health conditions studied

1

Description of health condition studied
Pain after appendectomy
ICD-10 code
R40-R46
ICD-10 code description
Symptoms and signs involving cognition, perception, emotional state and behaviour

Primary outcomes

1

Description
Postoperative pain
Timepoint
Before the intervention begins, and immediately after the intervention
Method of measurement
Visual Analog Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the acupressure group, in addition to routine therapies, the researcher will press the LI4 on the rotary clock for 5 minutes according to the clockwise model, and then apply the same pressure on the opposite side for 5 minutes. And
Category
Treatment - Other

2

Description
Control group: There is no intervention in the control group and patients will only receive routine treatment.
Category
Placebo

3

Description
Intervention group: In the ice massage group, in addition to routine treatments, for them massage will be given for 20 minutes at points LI4 and SP6 with a bag of ice (crushed ice at 3 cm in 3 cm).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sajjad Torbat-e Jam Hospital
Full name of responsible person
Somayeh Sadegh Nesab
Street address
Sajjadia Hospital, Imam Reza Square,Torbat-e Jam
City
Torbat-e-Jam
Province
Razavi Khorasan
Postal code
9691844177
Phone
+98 51 5252 1810
Email
shomia@ymail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Doctor Fereshteh Ghorat
Street address
Collegiate Paradise, Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8303
Email
shomia@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Sadigheh Khalili Shomia
Position
Master of Science in Nursing, Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Collegiate Paradise, Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8328
Fax
Email
shomia@ymail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Sadigheh Khalili Shomia
Position
Master of Science in Nursing, Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Collegiate Paradise,Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8328
Fax
Email
shomia@ymail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Sadigheh Khalili Shomia
Position
Master of Science in Nursing, Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Collegiate Paradise, Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8328
Fax
Email
shomia@ymail.com
Web page address

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
Undecided - It is not yet known if there will be 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
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