| CTRI Number |
CTRI/2019/09/021150 [Registered on: 09/09/2019] Trial Registered Prospectively |
| Last Modified On: |
24/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF TENS ON INCISIONAL PAIN AFTER CARDIAC SURGERY |
|
Scientific Title of Study
|
EFFECTS OF MODULATED TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION ON INCISIONAL PAIN POST CARDIAC SURGERY: A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VAIDEHI DARJI |
| Designation |
post graduate student |
| Affiliation |
Nitte institute of physiotherapy |
| Address |
Nitte institute of physiotherapy Deralakatte Mangalore Justice K.S Hegde hospital Deralakatte Mangalore Dakshina kannada
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9978695512 |
| Fax |
|
| Email |
vaidehidarji95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukumar S |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte institute of physiotherapy Deralakatte, Mangalore Justice K.S Hegde hospital Deralakatte Mangalore Dakshina kannada
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9611839013 |
| Fax |
|
| Email |
suku729@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukumar S |
| Designation |
Assistant Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte institute of physiotherapy Deralakatte, Mangalore Justice K.S Hegde hospital Deralakatte Mangalore Dakshina kannada
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9611839013 |
| Fax |
|
| Email |
suku729@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Hospital Deralakatte Mangalore |
|
|
Primary Sponsor
|
| Name |
Vaidehi Darji |
| Address |
Nitte Institute of Physiotherapy Deralakatte Mangalore |
| Type of Sponsor |
Other [[SELF]] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vaidehi Darji |
Justice K.S Hegde Hospital Deralakatte Mangalore |
Department of CTVS, CICU
Dakshina Kannada
KARNATAKA |
9978695512
vaidehidarji95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I279||Pulmonary heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Modulated TENS 2. Cardiac rehabilitation |
Treatment time for TENS: 30 mins once in a day following
Cardiac rehabilitaion |
| Comparator Agent |
1. Placebo TENS
2. cardiac rehabilitation |
Treatment time for TENS: 30 mins once in a day following cardiac rehabilitation |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. On and off pump cardiac surgery with median sternotomy
2. patients willing to participate
3. Post- operative (Acute phase) |
|
| ExclusionCriteria |
| Details |
1. patient with hemodynamic instability
2. unconscious/coma patients
3. patient with post-operative complications
4. patient having cardiac pacemaker and metal implants
5. subjects with impaired sensation, broken skin and infection at suture site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale (VAS) |
Visual Analogue Scale (VAS) : to identify the intensity of pain on 2nd POD and 7th POD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Beck anxiety Inventory Scale |
total of 21 items- to check the anxiety of the patient commonly after cardiac surgery in ICU on 2nd POD and 7th POD |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2019 |
| Date of Study Completion (India) |
20/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/02/2020 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is being conducted to find out the effects of modulated transcutaneous electrical nerve stimulation on incisional pain post cardiac surgery. The intervention will be given in two groups i.e Experimental Group (Group A): modulated TENS with cardiac rehabilitation and Control Group (Group B): placebo TENS with cardiac rehabilitation. 40 Patients were recruited, 20 in each group. The Outcome measure used is Visual Analog Scale to score the intensity of pain and Beck Anxiety Inventory to score the Anxiety level in the Patients, Both The outcomes were taken Pre Treatment and Post Treatment. The TENS is given For 30 minutes once in a day.
|