The Effect of an App-Based Intervention on Cycle Irregularities
Résumé de l'étude
Cycle disorders are common among premenopausal women and are usually attributed to hormonal causes. Conditions affecting the ovaries such as Polycystic Ovary Syndrome, thyroid diseases, disorders of the pituitary gland, as well as stress, excessive exercise, and eating disorders can be causative factors. Once the cause of the cycle disorder is identified, it can usually be treated hormonally or with other medications. Due to side effects, hormonal therapies are occasionally interrupted, making alternative methods necessary in these cases. Studies have shown that consistent lifestyle modifications in terms of dietary adjustments, physical activity, weight changes, and mindfulness can lead to the regulation of the female cycle. As access to medical information and mobile apps is facilitated by the use of smartphones today, this could positively contribute to lifestyle modification in cases of cycle disorders. However, there are currently no studies on mobile apps that offer programs to change lifestyle in cases of cycle disorders. NALU Health Sàrl has developed the NALU Cycle Flow App as a supportive measure for women with cycle disorders. This app includes texts, audios, and videos designed to support lifestyle changes. In our research project, we want to investigate whether the use of this app can lead to an improvement in cycle disorders. Furthermore, we aim to find out whether it is reasonable to use this app as a supportive measure in the context of cycle disorders in the future. For this purpose, we will compare a group of women with cycle disorders who use the app-based measures with a control group that does not. Participants will be randomly assigned to the groups.
(BASEC)
Intervention étudiée
The intervention being studied is the NALU Cycle Flow App, a lifestyle app designed to help women with irregular cycles regulate their cycles. This app offers a 10-week program consisting of various modules made up of videos, audios, and texts.
The app includes information about the menstrual cycle, lifestyle and mindset changes, as well as nutritional advice including recipes, physical exercises, and mindfulness exercises. Additionally, the app features a cycle and symptom diary. Furthermore, it provides access to a WhatsApp group for women with cycle disorders and monthly group meetings and Q&A sessions moderated by a certified health coach.
(BASEC)
Maladie en cours d'investigation
Cycle irregularities, Polycystic Ovary Syndrome, hypothalamic amenorrhea, hyperprolactinemia, hypothyroidism
(BASEC)
- Premenopausal women aged 18 and older - Women with cycle disorders (oligomenorrhea or secondary amenorrhea) who initially refuse hormonal therapy - Ownership of a smartphone (BASEC)
Critères d'exclusion
- Primary amenorrhea - Anatomical/organic causes of amenorrhea (e.g., Asherman syndrome, Mayer-Rokitansky-Küster-Hauser syndrome) - Perimenopause - Hormonal therapy - Current fertility treatment - Breastfeeding, pregnancy, postmenopause - Osteopenia, osteoporosis - Malignant disease - Medications or drugs that cause hyperprolactinemia (antipsychotics, antidepressants, opioids, etc.) - Simultaneous participation in other intervention studies (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
Inselspital Bern, repräsentiert durch Prof. M.D. Mueller, Frauenklinik
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Marietta Gulz
+41764497111
marietta.gulz@clutterinsel.chFrauenklinik Inselspital Bern
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
30.07.2025
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
A mobile application as supportive treatment of menstrual cycle irregularities. A randomized controlled trial. Short title: SYNC –Trial (Supporting Your Natural Cycle) (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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