Efficacy of mind body augmentation therapy on FET couples
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Increasing conception chances of couples undergoing infertility treatment in the Interventional group compared to the Control Group
研究概览
简要总结
The present prospective single-centre clinical trial seeks to evaluate the efficacy of a mind-body therapy treatments programme for stress management, anxiety, coping, and emotion regulation in infertility-treated couples (Frozen embryo transfer). In this paper, we will examine each scientific phase of clinical research in detail. Over the course of three months, baseline and post-test findings would be obtained from both the experimental (N=14) and control (N=14) groups. This study is a pragmatic, randomised, controlled experiment with parallel groups. This study examines the efficacy of the experimental biopsychosocial/mind-body therapeutic programme in reducing stress, uncertainty, and anxiety associated with infertility treatment (Frozen embryo transfer). The study is a 3-month parallel-group RCT with two arms-randomly assigned subjects to the experimental and control groups (1:1). The randomization will be stratified by age to ensure that intervention and control groups are equally distributed across all age groups. The results would demonstrate the efficacy of a mind-body/biopsychosocial therapy treatment programme in conjunction with FET.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 27.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Provision of signed and dated informed consent form.
- •Willingness to adhere to the study intervention regimen.
- •Known cases of infertility diagnosed with Primary infertility and Secondary infertility.
- •Age range: both partners range- 27-45 years.
- •Undergoing frozen embryo transfer (IVF) after approval from a medical doctor.
- •Only subjects whose ET is scheduled for at least 25 days later should be registered.
- •Or more than three days after registration, the menstrual cycle is about to begin
- •The couples enrolling for the study should be English Speaking.
- •Access necessary resources for a technology-based intervention (i.e., computer, smartphone, internet access)
- •Psychiatric Severity: Mild to moderate (Hamilton Depression Rating Scale score ≤ 16, Hamilton Anxiety Rating Scale (HAM-A) score ≤ 24, and not reporting any current suicidal ideation or intent).
排除标准
- •Not having consent from both partners or meeting the inclusion criteria Age of any partner above 45 years and below 27 years History of Severe Psychiatric Conditions as screened by a Registered Clinical Psychologist or Psychiatrist Couples opting for Surrogacy Any event medical condition or situation such that continued collection of follow-up study data would not be in the participants best interest or might require an additional treatment that would confound the interpretation of the study Treatment with another investigational drug or other intervention within the first 6 months Current smoker or tobacco use within 1 month.
结局指标
主要结局
Increasing conception chances of couples undergoing infertility treatment in the Interventional group compared to the Control Group
时间窗: 7 Weeks
次要结局
- Mitigating stress anxiety & emotional dysregulation among infertility treatment couples(Improvement in Physical health & quality of life)
研究者
Dr Vidya V Bhat
Radhakrishna Multispeciality Hospital and IVF Center