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

Not Applicable

Completed

• Conditions: Reproductive Disorder
• Interventions: Other: Breathing Control and Retention

• Registration Number: NCT06357208
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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

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 Timeline

• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-04
• Study First Posted: 2024-04-10
• Study Start: 2024-05-06
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breathing Control and Retention	Breathing Control and Retention	Breathing Control and Retention

Primary Outcome Measures

Name	Time	Method
Rate of stressed patients	month 1	with score of 27 on the Perceived Stress Scale

Secondary Outcome Measures

Name	Time	Method
STAI Y-A (anxiety state) scale	month 1	feeling anxious at the time with a score \> 39 for men and \> 47 for women

Trial Locations

Locations (1)

Chu de Nice; 🇫🇷 Nice, France