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Impact of Meditation and Reiki on Assisted Reproduction Techniques Outcomes

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Meditation presential
Reiki
Meditation (app)
round of conversation
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring in vitro fertilization, assisted reproduction, pregnancy rate, meditation, Reiki

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • ORIGEN - Centre for Reproductive MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Meditation presential

Reiki

Meditation (app)

round of conversation

Arm Description

Outcomes

Primary Outcome Measures

Pregnancy rate
presence of a gestational sac at 12 weeks of pregnancy

Secondary Outcome Measures

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

Full Information

First Posted
August 13, 2019
Last Updated
February 8, 2021
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT04058262
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
in vitro fertilization, assisted reproduction, pregnancy rate, meditation, Reiki

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meditation presential
Arm Type
Experimental
Arm Title
Reiki
Arm Type
Experimental
Arm Title
Meditation (app)
Arm Type
Experimental
Arm Title
round of conversation
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Meditation presential
Intervention Description
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
Intervention Name(s)
Reiki
Intervention Description
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
Intervention Name(s)
Meditation (app)
Intervention Description
Mindfulness meditation guided through 10-15 minute audio using app, to be practiced daily at home.
Intervention Type
Other
Intervention Name(s)
round of conversation
Intervention Description
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 Measure Information:
Title
Pregnancy rate
Description
presence of a gestational sac at 12 weeks of pregnancy
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
stress levels
Description
Stress evaluation using questionnaires DASS-21 (Depression, Anxiety and Stress Score) and/or PGWB-1 (Psichological General Well-being Index)
Time Frame
3 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
ORIGEN - Centre for Reproductive Medicine
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110051
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selmo Geber, Professor
Phone
55 31 21026363
Email
selmogeber@origen.com.br
Email
selmogeber@origen.com.br
First Name & Middle Initial & Last Name & Degree
Gelza Matos Nunes, MPhil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26742022
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.
Results Reference
background
PubMed Identifier
30328241
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.
Results Reference
result

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Impact of Meditation and Reiki on Assisted Reproduction Techniques Outcomes

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