Impact of Meditation and Reiki on Assisted Reproduction Techniques Outcomes

NCT04058262 | Unknown

• 1 other identifier: 13851019.9.0000.5149
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

in vitro fertilization; assisted reproduction; pregnancy rate; meditation; Reiki

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  presence of a gestational sac at 12 weeks of pregnancy

  12 weeks

Secondary Outcomes (1)

• stress levels

  3 weeks

Study Arms (4)

Meditation presential

EXPERIMENTAL

Other: Meditation presential

Reiki

EXPERIMENTAL

Other: Reiki

Meditation (app)

EXPERIMENTAL

Other: Meditation (app)

round of conversation

PLACEBO COMPARATOR

Other: round of conversation

Interventions

Meditation presential 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.

Meditation presential

Reiki 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.

Reiki

Meditation (app) OTHER

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

Meditation (app)

round of conversation 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.

round of conversation

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women submitted to Embryo Transfer
• Signed informed consent form
• Fresh or Frozen Embryo Transfer

You may not qualify if:

• No agreement to participate
• no embryo transfer
• surrogate embryo transfer

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

ORIGEN - Centre for Reproductive Medicine

Belo Horizonte, Minas Gerais, 30110051, Brazil

RECRUITING

Related Publications (3)

• 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.

  PMID: 26742022 BACKGROUND

• 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.

  PMID: 30328241 RESULT

• 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.

  PMID: 39374555 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Therapeutic Touch; Meditation; Amyloid

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 15, 2019
• Study Start: October 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: November 1, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)