Reproductive DisorderBHBBNCT06357208
IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTION
A study of Reproductive Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
the investigator propose for patient in the course of Medically Assisted Reproduction a study with to arm: one arm active "Breathing Control and Retention" and the other arm control Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Reproductive Disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 6 May 2024to 1 Jul 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unmarried woman and couple of women with societal infertility,
- couple with medical infertility defined as absence of pregnancy after 12 months without contraception,
- age greater than 18 years,
- patient who has signed informed consent and affiliated to social security.
- Patient available at the proposed slots over 4 weeks
Who cannot join
- pregnant women before starting the program,
- heart failure
- Thrombocytopenia
- epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTION BREATH HOLD TO BREATH BETTER PROGRAM IN MEDICALLY ASSISTED REPRODUCTION
the investigator propose for patient in the course of Medically Assisted Reproduction a study with to arm: one arm active "Breathing Control and Retention" and the other arm control
Read the detailed description
After signing the informed consent, the patient makes an appointment for an exchange with the psychologist at the Reproduction center.
During this exchange, the psychologist gives him the evaluation scales, explains to him when to complete them and re-explains the progress of the study.
Patients in the active "Breathing Control and Retention" group make 4 appointments, one week apart, with the Bluenery Academy. The participants self-assess 2 days before starting the breathing program (M0), 2 days after the end of the program, 1 month after starting the program (M1).
Patients in the "Usual follow-up" control group complete the self-assessments 2 days after the discussion with the psychologist (M0) and 1 month later (M1).
At the end of the 2 assessments, the patient was included. sends his assessment book to the psychologist.
An appointment will be made after the rating to communicate the results to them.
- Conditions
- Reproductive Disorder
- Being tested
- Breathing Control and Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing Control and RetentionOther
Also called respiratory exercice
4 appointments with training of Breathing Control and Retention
| Study group | Role | What they receive |
|---|---|---|
| Breathing Control and Retention | Experimental | Breathing Control and Retention Receives: Other: Breathing Control and Retention |
| Usual follow-up | No intervention | the patient come at the begin of the study and come back after one month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of stressed patients
with score of 27 on the Perceived Stress Scale
Measured: month 1
Secondary outcomes (1)
STAI Y-A (anxiety state) scale
feeling anxious at the time with a score > 39 for men and > 47 for women
Measured: month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start6 May 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie BENOIT, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357208
- Sponsor's protocol ID
- 23-AOI-06
- Other IDs
- 2023-A02687-38
- Acronym
- BHBB
- Status last verified
- Oct 2024
- First submitted
- 4 Apr 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTION BREATH HOLD TO BREATH BETTER PROGRAM IN MEDICALLY ASSISTED REPRODUCTION
- ClinicalTrials.gov ID
- NCT06357208
- Acronym / sponsor ID
- BHBB / 23-AOI-06
- Conditions
- Reproductive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 10 Apr 2024 (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.
the investigator propose for patient in the course of Medically Assisted Reproduction a study with to arm: one arm active "Breathing Control and Retention" and the other arm control
Detailed description
After signing the informed consent, the patient makes an appointment for an exchange with the psychologist at the Reproduction center.
During this exchange, the psychologist gives him the evaluation scales, explains to him when to complete them and re-explains the progress of the study.
Patients in the active "Breathing Control and Retention" group make 4 appointments, one week apart, with the Bluenery Academy. The participants self-assess 2 days before starting the breathing program (M0), 2 days after the end of the program, 1 month after starting the program (M1).
Patients in the "Usual follow-up" control group complete the self-assessments 2 days after the discussion with the psychologist (M0) and 1 month later (M1).
At the end of the 2 assessments, the patient was included. sends his assessment book to the psychologist.
An appointment will be made after the rating to communicate the results to them.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Control and Retention | Experimental | Other: Breathing Control and RetentionBreathing Control and Retention |
| Usual follow-up | No intervention | –the patient come at the begin of the study and come back after one month |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unmarried woman and couple of women with societal infertility,
- couple with medical infertility defined as absence of pregnancy after 12 months without contraception,
- age greater than 18 years,
- patient who has signed informed consent and affiliated to social security.
- Patient available at the proposed slots over 4 weeks
Key exclusion criteria (4 listed)
- pregnant women before starting the program,
- heart failure
- Thrombocytopenia
- epilepsy
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 |
|---|---|---|
| Breathing Control and RetentionAlso: respiratory exercice4 appointments with training of Breathing Control and Retention | Other | Breathing Control and Retention |
Primary outcome
Rate of stressed patients
Time frame: month 1
with score of 27 on the Perceived Stress Scale
1 secondary outcome
STAI Y-A (anxiety state) scale
Time frame: month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- 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.
Valérie BENOIT principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Reproductive Disorder, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 21 Oct 2024. 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 France. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of stressed patients (time frame: month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2024.