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Impact of Meditation and Reiki on Assisted Reproduction Techniques Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04058262
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Selmo Geber, Federal University of Minas Gerais

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.


Condition or disease Intervention/treatment Phase
Infertility Other: Meditation presential Other: Reiki Other: Meditation (app) Other: round of conversation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Impact of Meditation and Reiki on Assisted Reproduction Techniques Outcomes: a Randomized, Double Blinded, Placebo Controlled Trial
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 12 weeks ]
    presence of a gestational sac at 12 weeks of pregnancy


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058262


Locations
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Brazil
ORIGEN - Centre for Reproductive Medicine Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30110051
Contact: Selmo Geber, Professor    55 31 21026363    selmogeber@origen.com.br   
Contact       selmogeber@origen.com.br   
Sub-Investigator: Gelza Matos Nunes, MPhil         
Sponsors and Collaborators
Federal University of Minas Gerais
Publications of Results:
Other Publications:
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Responsible Party: Selmo Geber, Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT04058262    
Other Study ID Numbers: 13851019.9.0000.5149
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Selmo Geber, Federal University of Minas Gerais:
in vitro fertilization
assisted reproduction
pregnancy rate
meditation
Reiki
Additional relevant MeSH terms:
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Infertility