Impact of Meditation and Reiki on Assisted Reproduction Techniques Outcomes

February 8, 2021 updated by: Selmo Geber, Federal University of Minas Gerais

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Meditation presential
Other: 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.
EXPERIMENTAL: Reiki
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.
EXPERIMENTAL: Meditation (app)
Other: Meditation (app)
Mindfulness meditation guided through 10-15 minute audio using app, to be practiced daily at home.
PLACEBO_COMPARATOR: round of conversation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 12 weeks
presence of a gestational sac at 12 weeks of pregnancy
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stress levels
Time Frame: 3 weeks
Stress evaluation using questionnaires DASS-21 (Depression, Anxiety and Stress Score) and/or PGWB-1 (Psichological General Well-being Index)
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

November 1, 2021

Study Registration Dates

First Submitted

August 13, 2019

First Submitted That Met QC Criteria

August 14, 2019

First Posted (ACTUAL)

August 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13851019.9.0000.5149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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