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临床试验/NCT03159156
NCT03159156Unknown不适用

Respiration and Applied Tension Strategies to Reduce Vasovagal Reactions to Blood Donation

McGill University1 个研究点 分布在 1 个国家目标入组 408 人开始时间: 2015年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
408
试验地点
1
主要终点
Change in End Tidal CO2

研究概览

简要总结

For a number of years, researchers have examined the effects of the muscle-tensing technique, Applied Tension (AT), on blood donation-related vasovagal symptoms and donor retention. AT was developed originally to reduce symptoms and avoidance behaviour in people with strong fears of blood and needles (phobics). It was based on the idea that exercise-related increases in blood pressure might be able to counteract the effects of stimuli that lead to a decrease in delivery of blood to the brain. AT was adapted for non-phobic blood donors and significant reductions in self-reported vasovagal symptoms and the need for nurse-initiated treatment as well as increases in donor retention were observed in some groups.

That said, individual response to AT is quite variable. This is probably related to recent research indicating that exercise-related maintenance of heart rate and blood pressure plays only a minor role in reducing vasovagal symptoms. Rather, AT appears to be working at least in part by regulating breathing and reducing the possibility of hyperventilation. Pilot results suggest that a novel intervention aimed specifically at breathing may be more effective and reliable than traditional AT. To evaluate this idea, 408 blood donors at mobile clinics in colleges and universities will be assigned randomly to four conditions. In brief, 5-minute preparation sessions using a notebook computer, donors will either learn a respiration control technique to avoid hyperventilation, AT, both, or neither. As a manipulation check and also a means of examining mechanisms of the interventions, e.g., the possibility that AT may work by regulating breathing and CO2, participants will wear non-invasive portable capnometers while they are giving blood. Outcome will also be assessed by self-report of vasovagal symptoms, observational data, and number of return visits to a blood clinic in the following year verified by the provincial blood collection agency, Héma-Québec. As a secondary aim, the research will examine possible moderating effects of pre-donation anxiety and sex.

The development of simple, effective approaches to reduce vasovagal symptoms during blood donation has the potential to improve the blood donation experience and blood donor retention as well as encourage people who have never given blood to consider the procedure. It will also improve medical and dental care more generally given the use of needles in so many procedures.

详细描述

See above.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
None

盲法说明

Behavioral procedures that cannot be masked to participant or others.

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteer blood donors.

排除标准

  • 未提供

研究组 & 干预措施

Respiration Control

Experimental

Participants are taught a simple respiration control technique with a brief video presented on a notebook computer before giving blood. They are asked to breathe in a gentle shallow but regular fashion aimed at reducing risk for hyperventilation before and while giving blood.

干预措施: Respiration Control (Behavioral)

Blood Donation As Usual

No Intervention

Volunteer blood donors complete assessment materials, including assessment of respiratory activity, but otherwise undergo the typical blood donation procedure.

Applied Tension

Experimental

Participants are taught a simple muscle tensing technique with a brief video presented on a notebook computer before giving blood. They are asked to engage in repeated gentle 5-sec on, 5-sec off cycles of whole body isometric muscle tension before and while giving blood.

干预措施: Applied Tension (Behavioral)

Applied Tension/Respiration Control

Experimental

Participants are asked to practice both Applied Tension and Respiration Control before and while giving blood.

干预措施: Applied Tension/Respiration Control (Behavioral)

结局指标

主要结局

Change in End Tidal CO2

时间窗: change in mean value during the pre-donation waiting period (registration to going to chair, approximately 30 minutes) to the mean value in the donation chair (approximately 15 minutes)

assessed by ambulatory monitor (capnometer)

Change in Respiration Rate

时间窗: change in mean value during the pre-donation waiting period (registration to going to chair, approximately 30 minutes) to the mean value in the donation chair (approximately 15 minutes)

assessed by ambulatory monitor (capnometer)

Blood Donation Reactions Inventory

时间窗: completed in the recovery area, approximately 15 minutes after blood donation

questionnaire assessing presyncopal vasovagal symptoms

Research Assistant Observations

时间窗: during blood donation

participant anxiety, fainting, whether or not treatment for a vasovagal response required, etc., noted by a research assistant

次要结局

  • Change in Spielberger State Anxiety Scale Score(completed just after registering at the clinic and also in the recovery area, approximately 15 minutes after blood donation, to assess change in anxiety)
  • Medical Fears Survey(completed in the recovery area, approximately 15 minutes after blood donation)
  • Change in Systolic Blood Pressure(measured just after registering at the clinic and also in the recovery area, approximately 15 minutes after blood donation, to assess change in blood pressure)
  • Change in Diastolic Blood Pressure(measured just after registering at the clinic and also in the recovery area, approximately 15 minutes after blood donation, to assess change in blood pressure)
  • Change in Heart Rate(measured just after registering at the clinic and also in the recovery area, approximately 15 minutes after blood donation, to assess change in heart rate)
  • Blood Donor Return(one year after participating in the study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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