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临床试验/CTRI/2018/03/012322
CTRI/2018/03/012322已完成不适用

Evaluation of efficacy of valsalva for attenuating needle puncture pain in first time nonremunerated voluntary plateletpheresis donors

Sanjay Gandhi Postgraduate Institute Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2016年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
1
主要终点
To evaluate analgesic efficacy of valsalva procedure in attenuating the needle puncture pain in first time non-remunerated voluntary plateletphereis Donors

研究概览

简要总结

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

  1. 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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •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.

排除标准

  • •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.

结局指标

主要结局

To evaluate analgesic efficacy of valsalva procedure in attenuating the needle puncture pain in first time non-remunerated voluntary plateletphereis Donors

时间窗: 1 hr after platlet donation

次要结局

  • 1. To assess anxiety status of platelet donors(2. To compare pain severity between male and female donors)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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