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临床试验/NCT06357208
NCT06357208已完成不适用

IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTION BREATH HOLD TO BREATH BETTER PROGRAM IN MEDICALLY ASSISTED REPRODUCTION

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Rate of stressed patients

研究概览

简要总结

the investigator propose for patient in the course of Medically Assisted Reproduction a study with to arm: one arm active "Breathing Control and Retention" and the other arm control

详细描述

After signing the informed consent, the patient makes an appointment for an exchange with the psychologist at the Reproduction center.

During this exchange, the psychologist gives him the evaluation scales, explains to him when to complete them and re-explains the progress of the study.

Patients in the active "Breathing Control and Retention" group make 4 appointments, one week apart, with the Bluenery Academy. The participants self-assess 2 days before starting the breathing program (M0), 2 days after the end of the program, 1 month after starting the program (M1).

Patients in the "Usual follow-up" control group complete the self-assessments 2 days after the discussion with the psychologist (M0) and 1 month later (M1).

At the end of the 2 assessments, the patient was included. sends his assessment book to the psychologist.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unmarried woman and couple of women with societal infertility,
  • couple with medical infertility defined as absence of pregnancy after 12 months without contraception,
  • age greater than 18 years,
  • patient who has signed informed consent and affiliated to social security.
  • Patient available at the proposed slots over 4 weeks

排除标准

  • pregnant women before starting the program,
  • heart failure
  • Thrombocytopenia

结局指标

主要结局

Rate of stressed patients

时间窗: month 1

with score of 27 on the Perceived Stress Scale

次要结局

  • STAI Y-A (anxiety state) scale(month 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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