CClinicalTrials.gg
CompletedNCT06357208BHBBUpdated Oct 21, 2024

IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTION

An interventional study of Breathing Control and Retention in Reproductive Disorder, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-21.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Reproductive Disorder
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • pregnant women before starting the program,
  • heart failure
  • Thrombocytopenia
  • epilepsy
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Breathing Control and Retention

    Breathing Control and Retention

    Other: Breathing Control and Retention

  • No intervention
    Usual follow-up

    the patient come at the begin of the study and come back after one month

Interventions

  • OtherBreathing Control and Retention

    4 appointments with training of Breathing Control and Retention

    Also known as: respiratory exercice

06

What researchers measure

Primary outcomes

  1. Rate of stressed patients

    with score of 27 on the Perceived Stress Scale

    Time frame: 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

    Time frame: month 1

07

Study locations

1 site
  • Chu de Nice
    Nice, 06003, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06357208
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Apr 10, 2024
Start date
May 6, 2024
Primary completion
Jul 1, 2024
Completion
Jul 1, 2024
Last update
Oct 21, 2024

Study contacts

Valérie BENOIT
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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