InfertilityNCT04058262
Impact of Meditation and Reiki on Assisted Reproduction Techniques Outcomes
A study testing Meditation presential, Reiki and Meditation (app) in people with Infertility, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Meditation presential, Reiki and Meditation (app)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2020to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women submitted to Embryo Transfer
- Signed informed consent form
- Fresh or Frozen Embryo Transfer
Who cannot join
- No agreement to participate
- no embryo transfer
- surrogate embryo transfer
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
ORIGEN - Centre for Reproductive Medicine
Belo Horizonte, Minas Gerais, 30110051
Selmo Geber, Professor, 55 31 21026363, selmogeber@origen.com.br
selmogeber@origen.com.br
About this study
Official title: 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.
- Conditions
- Infertility
- Being tested
- Meditation presential, Reiki, Meditation (app), round of conversation
- Keywords
- in vitro fertilization, assisted reproduction, pregnancy rate, meditation, Reiki
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation presentialOther
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.
ReikiOther
Reiki will be performed in 45-minute sessions twice a week for 2 weeks then in a quiet room with controlled brightness and temperature.
Meditation (app)Other
Mindfulness meditation guided through 10-15 minute audio using app, to be practiced daily at home.
round of conversationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Meditation presential | Experimental | Not described Receives: Other: Meditation presential |
| Reiki | Experimental | Not described Receives: Other: Reiki |
| Meditation (app) | Experimental | Not described Receives: Other: Meditation (app) |
| round of conversation | Placebo comparator | Not described Receives: Other: round of conversation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
presence of a gestational sac at 12 weeks of pregnancy
Measured: 12 weeks
Secondary outcomes (1)
stress levels
Stress evaluation using questionnaires DASS-21 (Depression, Anxiety and Stress Score) and/or PGWB-1 (Psichological General Well-being Index)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Oct 2020
- Primary completionJun 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selmo Geber, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058262
- Sponsor's protocol ID
- 13851019.9.0000.5149
- Status last verified
- Feb 2021
- First submitted
- 13 Aug 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26742022Nery 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.
PubMed 30328241Nunes 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.
PubMed 39374555
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Meditation and Reiki on Assisted Reproduction Techniques Outcomes: a Randomized, Double Blinded, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04058262
- Acronym / sponsor ID
- 13851019.9.0000.5149
- Conditions
- Infertility
- Keywords
- in vitro fertilization, assisted reproduction, pregnancy rate, meditation, Reiki
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women submitted to Embryo Transfer
- Signed informed consent form
- Fresh or Frozen Embryo Transfer
Key exclusion criteria (3 listed)
- No agreement to participate
- no embryo transfer
- surrogate embryo transfer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation presentialFacilitator-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. | Other | Meditation presential |
| ReikiReiki will be performed in 45-minute sessions twice a week for 2 weeks then in a quiet room with controlled brightness and temperature. | Other | Reiki |
| Meditation (app)Mindfulness meditation guided through 10-15 minute audio using app, to be practiced daily at home. | Other | Meditation (app) |
| round of conversationThe 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. | Other | round of conversation |
Primary outcome
Pregnancy rate
Time frame: 12 weeks
presence of a gestational sac at 12 weeks of pregnancy
1 secondary outcome
stress levels
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Background: PubMed 26742022Li 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 publication: PubMed 30328241Nery 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.
- Derived from this study: PubMed 39374555Nunes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ORIGEN - Centre for Reproductive Medicine
Belo Horizonte, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation presential, Reiki and Meditation (app) in people with Infertility, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04058262, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.