| CTRI Number |
CTRI/2014/06/004695 [Registered on: 23/06/2014] Trial Registered Retrospectively |
| Last Modified On: |
29/12/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How the video based education influences the self efficacy in patients undergoing lung surgery? |
|
Scientific Title of Study
|
Influence of Video based Education on Self Efficacy in Post Pulmonary Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prerana Chittal |
| Designation |
Physiotherapist |
| Affiliation |
School of Allied Health Sciences, Manipal University |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences,
Manipal University,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
prerana.chittal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali K |
| Designation |
Professor |
| Affiliation |
Manipal University,Manipal |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences,
Manipal University,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9483929754 |
| Fax |
|
| Email |
vaishalik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali K |
| Designation |
Professor |
| Affiliation |
Manipal University,Manipal |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences,
Manipal University,
Manipal
Hassan
KARNATAKA
576104
India |
| Phone |
9483929754 |
| Fax |
|
| Email |
vaishalik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy,
School of Allied Health Sciences and Kasturba Medical College,
Manipal University,
Manipal - 576104
India |
|
|
Primary Sponsor
|
| Name |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy,
School of Allied Health Sciences,
Manipal University,
Manipal - 576104
India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Vaishali K |
Professor,
Department of Physiotherapy,
School of Allied Health Sciences,
Manipal University,
Manipal - 576104
India |
| Mrs Nivedita Prabhu |
Assistant Professor,
Department of Physiotherapy,
School of Allied Health Sciences,
Manipal University,
Manipal - 576104
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaishali K |
Cardiothoracic ICU |
2nd floor,
Kasturba Medical College and Hospital,
Manipal - 576104
India
Udupi
KARNATAKA |
9483929754
vaishalik@gmail.com |
| Prerana Chittal |
Cardiothoracic ICU |
2nd floor, Kasturba Medical College and Hospital, Manipal - 576104 India
Udupi
KARNATAKA |
9986403013
prerana.chittal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital, Manipal - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients undergoing decortication, exploratory thoracotomy,lobectomy, wedge or segmental resection, pneumonectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
usual routine physiotherapy exercises to be performed under the supervision of the physiotherapist but will not be shown the videoclip
Usual routine exercises as followed by the hospital -
Day of surgery
Breathing exercises, splinted coughing,ankle toe movements
Post operative day 1 (POD 1)
Exercises done on day of surgery & Short lever arm movements
Post operative day 2 (POD 2)
Exercises done on POD 1, Walks with heel toe gait pattern to sufficient distance, progress from short to long lever arm movement
Post operative day 3(POD 3)
Exercises done on POD 2 & Walking at bedside,Trunk exercises
Post operative day 4(POD 4)
100m walking without shortness of breath or symptoms,Stair climbing - one flight of stairs,Short lever arm movement with overhead elevation,Trunk exercises – lateral bend
Post operative day 5 & 6 (POD 5 & 6)
200-300m walking without shortness of breath,Trunk exercises,Stair climbing - 2 flights of stairs
Post operative day 7:
Increase the distance of walking gradually, climbing and descending 2 flights of stairs by discharge
|
| Intervention |
Experimental group |
Videoclip showing exercises to be performed after surgery and continuation of the usual exercises as followed by the hospital under supervision of the therapist. Educational videoclip will be shown preoperatively after admission showing risk factors, indication for surgery, avoidance of surgical complication by performing exercises after surgery. Time of videoclip - 9 minutes.
Usual exercises as followed by the hospital -
Day of surgery
Breathing exercises, splinted coughing,ankle toe movements
Post operative day 1 (POD 1)
Exercises done on day of surgery & Short lever arm movements
Post operative day 2 (POD 2)
Exercises done on POD 1, Walks with heel toe gait pattern to sufficient distance, progress from short to long lever arm movement
Post operative day 3(POD 3)
Exercises done on POD 2 & Walking at bedside,Trunk exercises
Post operative day 4(POD 4)
100m walking without shortness of breath or symptoms,Stair climbing - one flight of stairs,Short lever arm movement with overhead elevation,Trunk exercises – lateral bend
Post operative day 5 & 6 (POD 5 & 6)
200-300m walking without shortness of breath,Trunk exercises,Stair climbing - 2 flights of stairs
Post operative day 7:
Increase the distance of walking gradually, climbing and descending 2 flights of stairs by discharge
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
subjects undergoing elective pulmonary resection |
|
| ExclusionCriteria |
| Details |
subjects with Visual/Cognitive/Hearing deficits |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The MU self efficacy questionnaire for assessing the self efficacy |
at the time of discharge of the patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To assess the anxiety level of the patients before undergoing pulmonary surgery and at the time of discharge using Hospital Anxiety and Depression Scale (HADS) |
Preoperatively before randomization and at the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Video modeling allows the patient to observe
someone similar to him or her perform the activity and think that one is
capable of performing such behaviour leading to better compliance to treatment. Hence, video based education may improve self-efficacy of
the patients to perform exercises after pulmonary surgery |