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临床试验/NCT04058262
NCT04058262Unknown不适用

Impact of Meditation and Reiki on Assisted Reproduction Techniques Outcomes: a Randomized, Double Blinded, Placebo Controlled Trial

Federal University of Minas Gerais1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Pregnancy rate

研究概览

简要总结

Infertility is estimated to affect 15% of reproductive age couples worldwide and is defined as the inability to conceive after 12 months of unprotected sex for women under 35 or 6 months for women over 35 and is associated with stress, especially due to psychological factors such as anxiety, frustration and depression. In addition, women seeking treatment for pregnancy suffer additional stressors - significant emotional burdens and physical changes that can increase stress and anxiety levels. The possibility of an association between emotional stress and pregnancy outcome in women undergoing assisted reproduction treatment makes important therapies that address the psychological state of these women. Meditation and Reiki have been used to successfully reduce stress and anxiety in various health contexts.

Reiki is a complementary health approach in which practitioners lightly place their hands on or just above a person to facilitate their own healing response. Reiki has been used as an adjunctive therapy to treat the symptoms common to infertile women seeking treatment, including anxiety, stress, depression, anger, despair and depression. Reviews of randomized controlled trials concluded that implementation of the Reiki intervention in health centers resulted in mental health benefits, including reduced tension, mental confusion, anxiety and pain as well as improved quality of life.

Meditation can be defined as a form of mental training aimed at improving an individual's psychological capacities, such as attentional and emotional self-regulation. Meditation encompasses a family of practices that include mindfulness meditation, mantra meditation, yoga, tai chi and chi gong. Meditation has been used specifically in women undergoing IVF treatment to successfully reduce symptoms related to psychological distress. Studies measure the development of self-compassion, mechanisms of emotion regulation, and coping strategies related to infertility and quality of life in infertility. However, only one study showed a relationship between meditation and pregnancy rate. Unfortunately, the authors incorporated yoga and psychological approaches into meditation. Therefore, we designed this study to evaluate the impact of Meditation and Reiki on the outcome of assisted reproduction treatment.

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 (Investigator)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women submitted to Embryo Transfer
  • •Signed informed consent form
  • •Fresh or Frozen Embryo Transfer

排除标准

  • •No agreement to participate
  • •no embryo transfer
  • •surrogate embryo transfer

研究组 & 干预措施

Meditation (app)

Experimental

干预措施: Meditation (app) (Other)

Meditation presential

Experimental

干预措施: Meditation presential (Other)

Reiki

Experimental

干预措施: Reiki (Other)

round of conversation

Placebo Comparator

干预措施: round of conversation (Other)

结局指标

主要结局

Pregnancy rate

时间窗: 12 weeks

presence of a gestational sac at 12 weeks of pregnancy

次要结局

  • stress levels(3 weeks)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

Selmo Geber

Professor

Federal University of Minas Gerais

研究点 (1)

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