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