What is the Impact of an E-tool Based Mindfulness Intervention on Psychological Outcomes Compared to no Intervention in Infertile Women Undergoing Assisted Reproductive Technique Treatments: A Randomized Controlled Study?

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Infertility and its treatments can have a significant impact on women's psychological health. Anxiety has a negative impact on quality of life during treatment and can lead to withdrawal of care. the investigators would like to test the effectiveness of an application available via the Internet that offers daily exercises such as mindfulness meditation. Women in the treatment group will be instructed to practice meditation exercises using the 15-minute daily application during in vitro fertilization treatment until pregnancy testing. Women in the control group will have the standard care of the centre. The investigators will measure the effectiveness of the intervention on anxiety, depression, quality of life and mindfulness aspects. The investigators will also assess the impact on the chances of pregnancy and stress.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 42
Healthy Volunteers: t
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⁃ Participants fulfilling all of the following inclusion criteria are eligible for the study:

• French-speaking

• Women between the ages of 18-42 years

• Scheduled for the first IVF treatment in HUG/CHUV/CPMA Lausanne

• Access to a computer/smartphone/tablet with access to internet and a valid Email address

• Informed Consent as documented by her signature on the form (Appendix Informed Consent Form)

Locations
Other Locations
Switzerland
University Hospitals of Geneva
RECRUITING
Geneva
Contact Information
Primary
Isabelle Streuli, MD PhD
isabelle.streuli@hcuge.ch
0795534897
Backup
Sonia Campelo, RN
sonia.campelo@hcuge.ch
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2025-09-10
Participants
Target number of participants: 150
Treatments
Experimental: Mindfulness based psychological intervention
Patients allocated to the intervention group will receive an email with a link to a video and a pdf document. The video and the pdf document will introduce them to the principles and the practice of mindfulness. They will also receive an access code to an e-tool valid for 1 month. On this e-tool the patient will have access to short guided meditations both general and specific to infertility. They will be instructed to follow the découverte (discovery) program of 8 meditations of 10 minutes and then the program désir de parentalité (wish to become a parent) of 13 minutes 15 meditations of 13 minutes each. Patients will be given access to all other meditations programs of PetitBambou and instructed to meditate with the program for at least 10-15 minutes on a daily basis.
No_intervention: Standard care
The control group will have no additional intervention and will receive standard care in the institution. Women in all 3 study sites have access to counselling/psychological support with a trained professional before treatment initiation. During that consultation coping and stress reduction strategies are discussed.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Geneva

This content was sourced from clinicaltrials.gov