Clinical trial NCT04058262: Impact of Meditation and Reiki on Assisted Reproduction Techniques Outcomes
Official title: Impact of Meditation and Reiki on Assisted Reproduction Techniques Outcomes: a Randomized, Double Blinded, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: in vitro fertilization
assisted reproduction
pregnancy rate
meditation
Reiki
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2019-08-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Pregnancy rate
timeFrame: 12 weeks
Secondary outcomes:
measure: stress levels
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: ORIGEN - Centre for Reproductive Medicine
state: Minas Gerais
Study officials:
References:
citation: Li J, Long L, Liu Y, He W, Li M. Effects of a mindfulness-based intervention on fertility quality of life and pregnancy rates among women subjected to first in vitro fertilization treatment. Behav Res Ther. 2016 Feb;77:96-104. doi: 10.1016/j.brat.2015.12.010. Epub 2015 Dec 19.
citation: Nery SF, Paiva SPC, Vieira EL, Barbosa AB, Sant'Anna EM, Casalechi M, Dela Cruz C, Teixeira AL, Reis FM. Mindfulness-based program for stress reduction in infertile women: Randomized controlled trial. Stress Health. 2019 Feb;35(1):49-58. doi: 10.1002/smi.2839. Epub 2018 Oct 16.