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临床试验/NCT02236455
NCT02236455已完成不适用

Effects of Complementary Therapies Delivered Via Mobile Technologies on Surgical Patients' Reports of Anxiety, Pain, and Self-Efficacy in Healing: A Pilot Randomized Controlled Trial in Iceland

University of San Francisco2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
2
主要终点
Change from baseline state anxiety via the State Trait Anxiety Scale (STAI)

研究概览

简要总结

The purpose of this study is to determine the effects of complementary therapies delivered via mobile technologies have a therapeutic effect on surgical patients' anxiety, pain, and self-efficacy in healing reports before, following, and at 10-day follow-up.

详细描述

Patients scheduled for same-day surgery (SDS) often experience state anxiety, which may result in increased perceptions of pain and lower self-efficacy in healing. Complementary therapies (CT), such as relaxation technique, massage, guided imagery, and acupuncture have been shown to benefit patients undergoing surgery. The aim of this study was to examine the effects of audio relaxation technique (ART), music intervention (MI), nature video application with music (NVAM), and nature video application without music (NVA) delivered via mobile technologies on patients' state anxiety, pain perception, and perceived self-efficacy in healing.

Methods A randomized controlled trial (RCT) involving 105 SDS patients, who were assigned to an ART (n = 25), MI (n = 25), NVAM (n = 15), NVA (n = 16), or a control group (n = 24) were assessed for state anxiety via the State Trait Anxiety Inventory (STAI), self-reported pain using the numeric rating scale (NRS), and self-efficacy with the general self-efficacy scale (GSE) four days prior to surgery, immediately prior and following the surgical intervention, and at day five post-operative.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age range 18-75-years
  • English or Icelandic speaking
  • Cognitively alert and oriented to person, place, time, and situation
  • Intact visual and auditory senses

排除标准

  • History of substance abuse
  • Chronic pain lasting more than six months
  • Use of narcotic medication for more than six months
  • Major psychiatric disorders
  • Taking prescribed medications for thought disorders
  • Having ophthalmology and/or auditory surgery or impairments

结局指标

主要结局

Change from baseline state anxiety via the State Trait Anxiety Scale (STAI)

时间窗: Ten days

A randomized controlled trial (RCT) involving 105 SDS patients, who were assigned to an ART (n = 25), MI (n = 25), NVAM (n = 15), NVA (n = 16), or a control group (n = 24) were assessed for state anxiety via the State Trait Anxiety Inventory (STAI), self-reported pain using the numeric rating scale (NRS), and self-efficacy with the general self- efficacy scale (GSE) four days prior to surgery, immediately prior and following the surgical intervention, and at day five post-operative.

次要结局

  • Change in baseline pain level using the Numeric Rating Scale (NRS)(Ten Days)

研究者

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

Margaret M. Hansen

Associate Professor

University of San Francisco

研究点 (2)

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