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

Reproductive Disorder Clinical Trial

— BHBB  

Official title:

IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTIONBREATH HOLD TO BREATH BETTER PROGRAM IN MEDICALLY ASSISTED REPRODUCTION

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06357208
• Other study ID #: 23-AOI-06
• Secondary ID: 2023-A02687-38
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Valérie BENOIT
• Phone: 0492034702
• Email: benoit.v[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

we 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

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. They 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

• pregnant women before starting the program,

• heart failure

• Thrombocytopenia

• epilepsy

Related Conditions & MeSH terms

• Reproductive Disorder

Intervention

Other:
• Breathing Control and Retention
4 appointments with training of Breathing Control and Retention

Locations

Country	Name	City	State
France	Chu de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of stressed patients	with score of 27 on the Perceived Stress Scale	month 1
Secondary	STAI Y-A (anxiety state) scale	feeling anxious at the time with a score > 39 for men and > 47 for women	month 1