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Impact of Meditation and Reiki on Assisted Reproduction Techniques Outcomes

Sponsor
Federal University of Minas Gerais (Other)
Overall Status
Recruiting
CT.gov ID
NCT04058262
Collaborator
(none)
80
Enrollment
1
Location
4
Arms
13
Anticipated Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Meditation presential
  • Other: Reiki
  • Other: Meditation (app)
  • Other: round of conversation
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Nov 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Pregnancy rate [12 weeks]

    presence of a gestational sac at 12 weeks of pregnancy

Secondary Outcome Measures

  1. stress levels [3 weeks]

    Stress evaluation using questionnaires DASS-21 (Depression, Anxiety and Stress Score) and/or PGWB-1 (Psichological General Well-being Index)

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ORIGEN - Centre for Reproductive Medicine Belo Horizonte Minas Gerais Brazil 30110051

Sponsors and Collaborators

  • Federal University of Minas Gerais

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Selmo Geber, Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT04058262
Other Study ID Numbers:
  • 13851019.9.0000.5149
First Posted:
Aug 15, 2019
Last Update Posted:
Feb 9, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Selmo Geber, Professor, Federal University of Minas Gerais
in vitro fertilization
assisted reproduction
pregnancy rate
meditation
Reiki
Additional relevant MeSH terms:
Infertility

Study Results

No Results Posted as of Feb 9, 2021