IMPACT OF BREATH CONTROL AND RETENTION ON PATIENT STRESS. E.S IN MEDICALLY ASSISTED REPRODUCTION
BHBB
2 other identifiers
interventional
12
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2024
CompletedFirst Posted
Study publicly available on registry
April 10, 2024
CompletedStudy Start
First participant enrolled
May 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedOctober 21, 2024
October 1, 2024
2 months
April 4, 2024
October 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of stressed patients
with score of 27 on the Perceived Stress Scale
month 1
Secondary Outcomes (1)
STAI Y-A (anxiety state) scale
month 1
Study Arms (2)
Breathing Control and Retention
EXPERIMENTALBreathing Control and Retention
Usual follow-up
NO INTERVENTIONthe patient come at the begin of the study and come back after one month
Interventions
4 appointments with training of Breathing Control and Retention
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnant women before starting the program,
- heart failure
- Thrombocytopenia
- epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu de Nice
Nice, 06003, France
Study Officials
- PRINCIPAL INVESTIGATOR
Valérie BENOIT
Centre Hospitalier Universitaire de Nice
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2024
First Posted
April 10, 2024
Study Start
May 6, 2024
Primary Completion
July 1, 2024
Study Completion
July 1, 2024
Last Updated
October 21, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share