Impact of Meditation and Reiki on Assisted Reproduction Techniques Outcomes

NCT ID: NCT04058262

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Meditation presential

Group Type EXPERIMENTAL

Meditation presential

Intervention Type OTHER

Facilitator-guided meditation in groups or individually, in 45-minute sessions twice a week for 2 weeks, in a quiet room with controlled light and temperature, and comfortable cushions and chairs.

Reiki

Group Type EXPERIMENTAL

Reiki

Intervention Type OTHER

Reiki will be performed in 45-minute sessions twice a week for 2 weeks then in a quiet room with controlled brightness and temperature.

Meditation (app)

Group Type EXPERIMENTAL

Meditation (app)

Intervention Type OTHER

Mindfulness meditation guided through 10-15 minute audio using app, to be practiced daily at home.

round of conversation

Group Type PLACEBO_COMPARATOR

round of conversation

Intervention Type OTHER

The Round of Conversation will take place twice a week, lasting 45 minutes, for two weeks thereafter, at the same clinic, where women will talk about their lives, their needs, how they handle reported situations and how also your skills and preferences.

Interventions

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Meditation presential

Facilitator-guided meditation in groups or individually, in 45-minute sessions twice a week for 2 weeks, in a quiet room with controlled light and temperature, and comfortable cushions and chairs.

Intervention Type OTHER

Reiki

Reiki will be performed in 45-minute sessions twice a week for 2 weeks then in a quiet room with controlled brightness and temperature.

Intervention Type OTHER

Meditation (app)

Mindfulness meditation guided through 10-15 minute audio using app, to be practiced daily at home.

Intervention Type OTHER

round of conversation

The Round of Conversation will take place twice a week, lasting 45 minutes, for two weeks thereafter, at the same clinic, where women will talk about their lives, their needs, how they handle reported situations and how also your skills and preferences.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Selmo Geber

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ORIGEN - Centre for Reproductive Medicine

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Selmo Geber, Professor

Role: primary

55 31 21026363

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 26742022 (View on PubMed)

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.

Reference Type RESULT
PMID: 30328241 (View on PubMed)

Nunes GM, Paiva SPC, Geber S, Serra ASVA, Sampaio MAC, Tavares RLC. The impact of extremely brief meditation and brief mindfulness interventions on assisted reproductive technologies success rates: A randomised controlled trial. Explore (NY). 2024 Nov-Dec;20(6):103067. doi: 10.1016/j.explore.2024.103067. Epub 2024 Sep 29.

Reference Type DERIVED
PMID: 39374555 (View on PubMed)

Other Identifiers

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13851019.9.0000.5149

Identifier Type: -

Identifier Source: org_study_id

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