1. Home
  2. Approved trials
  3. » فارسی

Comparison of transcutaneous electrical nerve stimulation in acupuncture points with the incision site on post operative complications and physiological indicators after appendectomy

Protocol summary

Summary
Objectives: The purpose of this study is to compare the effect of transcutaneous electrical nerve stimulation (TENS) in acupuncture point (SP6, ST36, LI4) with the incision site on post operative complication such as pain, nausea and vomiting and physiological indications. Inclusion criteria: Men and women between ages 15-45 under appendectomy operation in torbat jaam sajadie hospital after taking cognitive satisfaction are examined.Exclusion criteria are: history of skin disease, history of cardiac disease, addiction, diabetes, history of cognitive or mental disease, pregnancy and history of using acupuncture or TENS and by accessing any accidental during intervention such as bleeding or withdrawal of participation in intervention will be leaved. Setting and conduct: Patients will divided accidentally to 4 groups after recovery: first group TENS in acupuncture points, second group TENS in place of incision, third group TENS in form placebo, the forth group researcher does not interfere.In all groups routine cures done during study. Main outcome measures: pain, nausea and vomiting, physiological indications, amount of taking lenitive before, immediately after intervention, 10 minutes after and at the end of 20 minutes are recorded and compared.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2015061322682N2
Registration date: 2015-11-07, 1394/08/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-07, 1394/08/16
Registrant information
Name
Mahsa Moazzen Ahmadi
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3514
Email address
moazzenm2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Gonabad University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of transcutaneous electrical nerve stimulation in acupuncture points with the incision site on post operative complications and physiological indicators after appendectomy
Public title
Comparison of transcutaneous electrical nerve stimulation in acupuncture points with the incision site
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: men and women 14-45 years old; under appendectomy. Exclusion criteria; history of skin disease; history of cardiac disease; cognitive disease; diabetes disease; addiction; history of using TENS or acupuncture and pregnancy.
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will divided accidentally to 4 groups (Table of random numbers)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committe of Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Postal code
9691793718
Approval date
2015-03-11, 1393/12/20
Ethics committee reference number
GMU.REC.1393.134

Health conditions studied

1

Description of health condition studied
Appendicitis
ICD-10 code
k35-2,k35-
ICD-10 code description
Appendicitis (acute) with generalized (diffuse) peritonitis following rupture or perforation, Acute appendicitis with localized peritonitis with or without rupture or perforation Acute appendicitis with peritoneal absces,Acute appendicitis without

Primary outcomes

1

Description
pain
Timepoint
before intervention, immediately after intervention, 10 minute after and at the end of 20 minute intervention
Method of measurement
Visual Analogue Scale of pain

2

Description
nausea
Timepoint
before intervention, immediately after intervention, 10 minute after and at the end of 20 minute intervention
Method of measurement
Visual Analogue Scale of nausea

Secondary outcomes

1

Description
amount of pain relief
Timepoint
before intervention, immediately after intervention, 10 minute after and at the end of 20 minute intervention
Method of measurement
cc

2

Description
blood pressure
Timepoint
before intervention,immediately after intervention,10 minute after and at the end of 20 minute intervention
Method of measurement
pressure indicator

3

Description
Heart rate
Timepoint
before intervention, immediately after intervention, 10 minute after and at the end of 20 minute intervention
Method of measurement
Probe monitor

4

Description
respiratory rate
Timepoint
before intervention, immediately after intervention, 10 minute after and at the end of 20 minute intervention
Method of measurement
see chest

Intervention groups

1

Description
15 minute after discharging of recovery in first group, in addition to routine cure in part, patients are cured under transcutaneous electrical nerve stimulation in acupuncture point (LI4, ST36, PC6) put in form of two sided with frequency 100 HZ and circuiting within tolerance for 20 minutes.
Category
Treatment - Other

2

Description
15 minutes after discharging of recovery in second group, in addition to routine cures in part, patients are cured under transcutaneous electrical nerve stimulation in places of incision (4 cm far from cutting place in form two sided) with frequency 100 HZ and circuitry within tolerance for 20 minute.
Category
Treatment - Other

3

Description
15 minute after discharging of recovery, in third group in addition to routine cures in part, patients are cured under transcutaneous electrical nerve stimulation in acupuncture points and incision site (instruments pads are putting in related points but TENS device does not tern) for 20 minute.
Category
Treatment - Other

4

Description
15 minute after discharging of recovery in fourth group, just routine cures are done and there is no intervention by researcher.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sajadie Hospital of torbat jam
Full name of responsible person
Mahsa Moazzen Ahmadi
Street address
Sajadie Hospital, Fariman special road, Torbat Jam, Khorasan Razavi, Iran
City
Torbat jaam

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vic Chancellor for research of Gonabad University of Medical Sciences
Full name of responsible person
Dr Ali Mohammadpour
Street address
Vice chancellor research of Gonabad University of Medical Sciences, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic Chancellor for research of Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Dr Mousa Sajjadi
Position
PHD of nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 3513
Fax
+98 51 5722 3815
Email
Sajjadi1975@gmail.com
Web page address
www.gum.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mahsa Moazzen Ahmadi
Position
MSc Student, Department of Medical Surgical Nursing
Other areas of specialty/work
Street address
Sajadie Hospital, Fariman special road, Torbat Jam, Khorasan Razavi, Iran
City
Torbat Jam
Postal code
9576175544
Phone
+98 51 5252 9312
Fax
+98 51 5252 1817
Email
Moazzenm2@mums.ac.ir
Web page address
www.mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mahsa Moazzen Ahmadi
Position
MSc Student, Department of Medical Surgical Nursing
Other areas of specialty/work
Street address
Sajadie Hospital, Friman special road, Torbat Jam, Khorasan Razavi, Iran
City
Torbat Jam
Postal code
9576175544
Phone
+98 51 5252 9312
Fax
+98 51 5252 1817
Email
moazzenm2@mums.ac.ir
Web page address
www.mums.ac.ir

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
Loading...