Impact of a Mindfulness Intervention on Infertile Women Undergoing Assisted Reproductive Technique Treatments

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorUniversity Hospital, Geneva

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Psychotropic medication

Ongoing psychiatric/psychological treatment

Known severe psychiatric co-morbidity

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness based psychological intervention

    Behavioral

    Women in the intervention group will have to use an application during 1 month. They will do meditation during 15 minutes each day.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Mindfulness based psychological interventionExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in anxiety state scores

The primary aim of the study is to evaluate the effect of an e-tool based intervention versus standard care without intervention on anxiety state measured by the French version of state trait anxiety index in infertile women undergoing ART. State trait anxiety index state scores will be evaluated by completion of a questionnaire at 3 time points: baseline, at the time of the oocyte retrieval, on the day before the pregnancy test (before the results). A score between 31 and 36 is considered as normal score.

Time frame
1 month

Secondary outcomes

Other outcomes

Sponsors and contacts

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