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

NCT ID: NCT06357208

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2024-07-01

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.

Conditions

Reproductive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Breathing Control and Retention

Breathing Control and Retention

Group Type: EXPERIMENTAL

Breathing Control and Retention

Intervention Type: OTHER

4 appointments with training of Breathing Control and Retention

Usual follow-up

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Breathing Control and Retention

4 appointments with training of Breathing Control and Retention

Intervention Type: OTHER

Other Intervention Names

respiratory exercice

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valérie BENOIT

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

Chu de Nice

Nice, , France

Countries

France

Other Identifiers

2023-A02687-38

Identifier Type: OTHER

Identifier Source: secondary_id

23-AOI-06

Identifier Type: -

Identifier Source: org_study_id