The effect of TENS for shoulder pain relief in patients after gynecologic laparascopic surgery
Design
The present study is a randomized clinical trial study. In this study, 56 patients with informed consent were randomly assigned to each group underwent laparoscopic gynecology surgery. All of these patients underwent the same protocol of anesthesia according to entry criteria. Individuals are randomly assigned into two intervention and control groups. In the intervention group, two electrodes are placed vertically down the sides of the shoulders under the neck on the right and left side with the angle. The electrodes are inserted by the pain therapeutic group and used in the TENSE group twice a TENSE time and used for TENS for 20 minutes each time. In the control group, the device is not switched on.
The study is done in parallel and double-blind so that the subjects and the analyst will not be aware of the allocation of the two groups.
Settings and conduct
This study is carried out at Rasoul-e-Akram Hospital in Tehran. Patients before the use of TENS and after using TENS by pain group anesthesiologist, patients at intervals of 2, 4, 8, 24 and 48 hours and then 72 hours after laparoscopy in terms of scour, shoulder pain, nausea, vomiting, recovery quality and the need for analgesia were evaluated. The study was double-blind so that the subjects and the analyst would not be aware of the allocation of the two groups.
Participants/Inclusion and exclusion criteria
Patients undergoing gynicologic laparoscopy are included in the study
Intervention groups
Intervention group: Patients undergoing laparoscopic surgery to reduce pain using TENS (Transcutaneous electrical nerve stimulation)
Control group: Patients undergoing laparoscopic surgery without using TENS (Transcutaneous electrical nerve stimulation)
Main outcome variables
Pain score؛ Vomitting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150819023684N4
Registration date:2018-03-14, 1396/12/23
Registration timing:registered_while_recruiting
Last update:2018-03-14, 1396/12/23
Update count:0
Registration date
2018-03-14, 1396/12/23
Registrant information
Name
Sepideh Khodaverdi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2562
Email address
khodaverdi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-02, 1396/12/11
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of TENS (Transcutaneous Electrical Nerve Stimulation) for shoulder pain relief in patients after gynecologic laparoscopic surgery
Public title
The effect of TENS (Transcutaneous Electrical Nerve Stimulation) for shoulder pain relief in patients after gynecologic laparascopic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing gynecological laparoscopy
Age 18 to 45
Lack of epilepsy
No malignancy
No DVT
Lack of fragile and damaged skin in areas where TENS is used
The lack of a pacemaker
The lack of electronic implants
The length of surgery is less than 3 hours
Intra-abdominal pressure during laparacopy is not higher than 14
Absence of lesions and diaphragmatic diseases
Lack of lung problems
No SAS Depression
Morbid obese patients
Lack of addiction
Exclusion criteria:
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is simple, so that patients are randomly assigned to node A (intervention) and group B (control) after well-informed consent before surgery.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is done in two ways, so that subjects and statistical analyzers do not know the allocation of the two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-03-01, 1396/12/10
Ethics committee reference number
IR.IUMS.REC 1396.31054
Health conditions studied
1
Description of health condition studied
Shoulder pain after laparoscopy
ICD-10 code
U00-U85
ICD-10 code description
XXII Codes for special purposes
Primary outcomes
1
Description
Shoulder pain after laparoscopy based on VAS score
Timepoint
At intervals, 2, 4, 8, 24 and 48 hours, and then 72 hours after laparoscopy in terms of scores of shoulder pain
Method of measurement
VAS score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients undergoing gynecologic laparoscopic surgery to reduce pain using TENS (Transcutaneous electrical nerve stimulation)
Category
Treatment - Devices
2
Description
Control group: Patients undergoing gynecologic laparoscopic surgery without using TENS (Transcutaneous electrical nerve stimulation)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-e-Akram Hospital, Maziar Mansouri St., Sattarkhan Street
Full name of responsible person
Sepideh Khodaverdi
Street address
Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2652
Email
sepidehkhodaverdi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tasnim behboud arman company
Full name of responsible person
Seyed Jafar Razavi Shirazi
Street address
Shariati avenue, above the Roman bridge, Mousavand St., Karimi St., Alley Sabeti, ulat 78
City
Tehran
Province
Tehran
Postal code
1933983911
Phone
+98 21 2267 9440
Email
info@tasnimbehboud.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tasnim behboud arman company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sepideh Khodaverdi
Position
Professor Asistant
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Iran University Of Medical science, side of Milad tower, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Fax
+98 21 6650 9283
Email
khodaverdi.s@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mania Kaveh
Position
Assistant of womens Laparoscopic Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hazrat Rasool Akram Educational and Research Center, Niayesh Avenue, Sattarkhan Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Fax
Email
maniakaveh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mania Kaveh
Position
Assistant of womens Laparoscopic Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hazrat Rasool Akram Educational and Research Center, Niayesh Avenue, Sattarkhan Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2562
Fax
Email
maniakaveh@gmail.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
No - There is not 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