| CTRI Number |
CTRI/2018/03/012322 [Registered on: 05/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of blowing in blood pressure pipe to reduce needle pain in first time voluntary platelet donors |
|
Scientific Title of Study
|
Evaluation of efficacy of valsalva for attenuating needle puncture pain in first time nonremunerated voluntary plateletpheresis donors |
| Trial Acronym |
EVANPPD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Sanjay Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, SGPGIMS, Lucknow
Department of Anaesthesiology, , SGPGIMS, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
0522-2665528 |
| Fax |
0522-2668017 |
| Email |
drsanjaygupta9@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Sanjay Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, , SGPGIMS, Lucknow
Department of Anaesthesiology, , SGPGIMS, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
0522-2665528 |
| Fax |
0522-2668017 |
| Email |
drsanjaygupta9@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Sanjay Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, , SGPGIMS, Lucknow
Department of Anaesthesiology, , SGPGIMS, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
05222665529 |
| Fax |
0522-2668017 |
| Email |
drsanjaygupta9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research Institute, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow,India. 226014 |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute Of Medical Sciences |
| Address |
Sanjay Gandhi Postgraduate Institute Of Medical Sciences, Lucknow-226014 Uttar Pradesh India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Sanjay Kumar |
Sanjay Gandhi Postgraduate Institute Of Medical Sciences |
Transfusion Department Ground floor B block
Lucknow
UTTAR PRADESH |
8765974045
0522-2668017
drsanjaygupta9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy voulunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I (Valsalva) |
Donors will be asked to blow into a rubber tubing connected to sphygmomanometer and raise the mercury column up to 30 mmHg for a period of at least 20 sec. after valsalva needle puncture for donation will be done |
| Comparator Agent |
Group II (Control) |
Will be acting as control and will not perform valsalva. Just after performing valsalva maneuver, phlebotomy would be done with a 16 G intravenous needle (in the antecubital vein) by an expert |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Group II (Control): Will be acting as control and will not perform valsalva. Just after performing valsalva maneuver, phlebotomy would be done with a 16 G intravenous needle (in the antecubital vein) by an expert |
|
| ExclusionCriteria |
| Details |
Repeated plateletpheresis donors, donors with abnormal skin condition such as scar, infection at the site of proposed needle puncture, scars, eczema, those in whom the venipuncture would be difficult or traumatic (blood extravasation, hematoma, nerve injury, arterial puncture injury, allergy, veinitis, thrombosis, sign and symptom of vasovagal syncope, convulsion, sweating), donor with history of syncope/vasovagal attack, anxiety disorder, donors requiring > 1 attempt for successful intravenous cannulation or change of site . Donors who are not able to hold the mercury column up to 30 mmHg for a period of at least 20 seconds would be excluded from the study. |
|
|
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 |
| To evaluate analgesic efficacy of valsalva procedure in attenuating the needle puncture pain in first time non-remunerated voluntary plateletphereis Donors |
1 hr after platlet donation |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. To assess anxiety status of platelet donors
2. To compare pain severity between male and female donors
|
1 hr after platlet donation |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "160"
Final Enrollment numbers achieved (India)="160" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/03/2016 |
| Date of Study Completion (India) |
18/09/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
still not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Aims and objectives: Primary objective: To evaluate the efficacy of valsalva procedure in attenuating the needle puncture pain in first time non-remunerated voluntary plateletpheresis donors
Secondary objective: 1.To assess anxiety status of platelet donors 2. To compare pain severity between male and female donors
Methodology: Blood Donors donating blood at Blood Donation center of the Department of Transfusion Medicine, will be randomized with the help of a computer-generated table of random numbers into 2 groups of 80 each. Group I (Valsalva): Donors will be asked to blow into a rubber tubing connected to sphygmomanometer and raise the mercury column up to 30 mmHg for a period of at least 20 sec; Group II (Control): will be acting as control and will not perform valsalva. Just after performing valsalva maneuver, phlebotomy would be done with a 17 G intravenous needle (in the antecubital vein) by an expert Exclusion: Repeated plateletpheresis donors, donors with abnormal skin condition such as scar, infection at the site of proposed needle puncture, scars, eczema, those in whom the venipuncture would be difficult or traumatic (blood extravasation, hematoma, nerve injury, arterial puncture injury, allergy, veinitis, thrombosis, sign and symptom of vasovagal syncope, convulsion, sweating), donor with history of syncope/vasovagal attack, anxiety disorder, donors requiring > 1 attempt for successful intravenous cannulation or change of site . Donors who are not able to hold the mercury column up to 30 mmHg for a period of at least 20 seconds would be excluded from the study. We therefore wish to evaluate its efficacy in attenuating the phlebotomy venipuncture pain. |