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临床试验/NCT02690194
NCT02690194已完成不适用

A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2015年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure

研究概览

简要总结

The primary aim is to investigate the efficacy of Buddhify relaxation therapy in reducing the stress and anxiety levels of patients. The secondary aim is to investigate the effect of prior stress and anxiety levels on the perceived pain level of undergoing a medical procedure, reported post-procedure.

详细描述

Undergoing medical procedures is reported to cause stress and anxiety among many individuals.This can trigger the sympathetic nervous response, including decreased skin temperature, increased pulse, and increased blood pressure. While evolutionary advantageous, this response has deleterious effects on the healing process. Heightened stress levels can also trigger an increased release of cortisol, a naturally produced steroid hormone known to hinder the immune response. In response to high levels of stress, a patient's tolerance for pain decreases and the perceived pain level increases.

Relaxation techniques can assist in reducing the stress and anxiety levels of a patient, which allows for lower perceived pain and more rapid healing. Many relaxation techniques exist, including acupuncture, child life intervention, breathing therapy and guided imagery. Buddhify, a mobile application, incorporates breathing therapy and audio-guided imagery into brief relaxation sessions, with the goal of reducing the stress and anxiety levels of the user. This application presents a convenient option for patients to use prior to undergoing a procedure. If proven to be effective, this application could be more widely used to help reduce the stress level, anxiety level and subsequent perceived pain level of patients, ultimately improving their healing reaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 14 and older undergoing an invasive procedure by Dr. Gianmichel Corrado at the Division of Sports Medicine of Boston Children's Hospital.

排除标准

  • 未提供

研究组 & 干预措施

Placebo Group

Placebo Comparator
  1. Pre-Placebo therapy
  • Blood pressure, pulse, and respiration rate
  • State-Trait Anxiety Inventory
  1. PLACEBO THERAPY SESSION
  2. Post-Placebo therapy/Pre-procedure
  • Blood pressure, pulse, and respiration rate
  • State-Trait Anxiety Inventory
  1. PROCEDURE
  2. Post-procedure -Rate pain level of procedure

干预措施: Placebo Group (Device)

Experimental (Buddhify) Group

Experimental
  1. Pre-Buddhify therapy
  • Blood pressure, pulse, and respiration rate
  • State-Trait Anxiety Inventory
  1. BUDDHIFY THERAPY SESSION
  2. Post-Buddhify therapy/Pre-procedure
  • Blood pressure, pulse, and respiration rate
  • State-Trait Anxiety Inventory
  1. PROCEDURE
  2. Post-procedure -Rate pain level of procedure

干预措施: Buddhify Therapy (Device)

Control Group

No Intervention
  1. Pre-Procedure
  • Blood pressure, pulse, and respiration rate
  • State-Trait Anxiety Inventory
  1. PROCEDURE
  2. Post-procedure -Rate pain level of procedure

结局指标

主要结局

Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure

时间窗: Pre-therapy/pre-procedure

Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg

Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate

时间窗: Pre-therapy/pre-procedure

Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.

Pre-therapy/Pre-procedure Anxiety Level

时间窗: Pre-therapy/pre-procedure

Pre-therapy/pre-procedure anxiety level measure by the State-Trait Anxiety Inventory. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.

Pre-therapy/Pre-procedure Stress Level Measured by Pulse

时间窗: Pre-therapy/pre-procedure

Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.

次要结局

  • Injection Experiences(Pre-therapy/Pre-procedure)
  • Post-therapy/Pre-procedure Change in Anxiety Level(Post-therapy/pre-procedure)
  • Drink in Last Hour(Pre-therapy/Pre-procedure)
  • Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate(Post-therapy/pre-procedure)
  • Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale(Immediately post-procedure)
  • Eat in Last Hour(Pre-therapy/Pre-procedure)
  • Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse(Post-therapy/pre-procedure)
  • Exercise in Last Hour(Pre-therapy/Pre-procedure)
  • Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure(Post-therapy/Pre-procedure)
  • Number of Injections(Pre-therapy/Pre-procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianmichel Corrado

Gianmichel D. Corrado, MD

Boston Children's Hospital

研究点 (2)

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