Brain Fog, Menopause, Psychological Well-being
Conditions
Keywords
menopause, brain fog, psychological well-being
Brief summary
The goal of this clinical trial is to evaluate the effect of a mobile game-based cognitive intervention on brain fog and psychological well-being in menopausal women aged 45-55 years. The main questions it aims to answer are: Are Brain Fog Scale scores lower among women in the mobile game intervention group compared with women in the control group? Are Warwick-Edinburgh Mental Well-Being Scale scores higher among women in the mobile game intervention group compared with women in the control group? Do women participating in the mobile game intervention demonstrate greater reductions in Brain Fog Scale scores and greater improvements in Warwick-Edinburgh Mental Well-Being Scale scores after the intervention compared with their baseline measurements? Researchers will compare participants receiving the mobile game-based cognitive intervention with participants receiving routine follow-up only to determine the effectiveness of the intervention on brain fog and psychological well-being. Participants will: Complete baseline assessments using the Brain Fog Scale and the Warwick-Edinburgh Mental Well-Being Scale. Be randomly assigned to either the intervention group or the control group. Use the cognitive training mobile game for 15 minutes per day, 5 days per week, for 6 weeks if assigned to the intervention group. Receive routine follow-up only if assigned to the control group. Complete post-intervention assessments at the end of the 6-week study period.
Detailed description
Menopause is a natural stage in a woman's life characterized by hormonal changes that may affect physical, psychological, and cognitive health. In addition to vasomotor symptoms, many women report cognitive difficulties during the menopausal transition, commonly referred to as "brain fog." Brain fog encompasses subjective experiences such as reduced concentration, forgetfulness, slower information processing, and difficulties in maintaining attention. These cognitive challenges may negatively influence daily functioning, work productivity, self-confidence, and overall quality of life. Psychological well-being is another important aspect of women's health during menopause. Hormonal fluctuations, aging-related changes, and psychosocial factors may contribute to declines in well-being. Cognitive difficulties and psychological well-being are closely interrelated, as persistent cognitive concerns may increase emotional distress and negatively affect individuals' perceptions of their mental health and well-being. Digital health interventions have gained increasing attention as accessible and scalable approaches for supporting health promotion and symptom management. Among these interventions, mobile games offer opportunities to engage users through interactive and motivating activities while facilitating learning and cognitive stimulation. Cognitive training exercises delivered through mobile games may support cognitive functions such as attention, working memory, cognitive flexibility, verbal fluency, and visual memory. However, evidence regarding the effectiveness of mobile game-based cognitive interventions specifically designed for menopausal women remains limited. The mobile game used in this study was developed to provide cognitive training through gamified activities targeting multiple cognitive domains. The intervention incorporates structured exercises intended to support attention, memory, problem-solving, and cognitive flexibility while promoting sustained engagement through an interactive digital format. This study will investigate whether participation in a mobile game-based cognitive intervention can improve cognitive functioning related to brain fog and enhance psychological well-being among menopausal women. The findings are expected to contribute to the growing evidence base on non-pharmacological digital interventions and may support the development of accessible, low-cost, and sustainable approaches for promoting cognitive and psychological health during menopause.
Interventions
BEHAVIORALMenopause Mobile Game
Participants in the intervention group will use a mobile game specifically designed for menopausal women to support cognitive functioning. The game includes interactive exercises and activities targeting attention, memory, processing speed, and other cognitive skills. Participants will use the mobile game throughout the intervention period in addition to routine care.
Sponsors
Medipol University
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 45-55 years * Able to read and write in Turkish * Able to use a smartphone (Android or iOS) * Amenorrhea for at least 12 months * Willing to participate and provide written informed consent
Exclusion criteria
* Diagnosis of serious neurological disorders such as dementia, Alzheimer's disease, epilepsy, or multiple sclerosis * Diagnosis of severe psychiatric disorders such as major depression, bipolar disorder, or schizophrenia * Regular use of medications that may significantly affect cognitive function, including antiepileptics, antiparkinsonian drugs, antipsychotics, or antidepressants * Participation in cognitive training, memory training, or a similar digital intervention within the last 6 months * Visual, auditory, or motor impairments that would prevent the use of the mobile application * Participants scoring within the lowest 25% quartile (Q1) on the Brain Fog Scale
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain fog | Baseline and Week 6 | Change in Brain Fog Scale total score from baseline to post-intervention. The Brain Fog Scale is a 30-item instrument assessing cognitive, physical, and psychological symptoms of brain fog. Total scores range from 30 to 150, with higher scores indicating greater brain fog severity (worse outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Warwick-Edinburgh Mental Well-Being | Baseline and Week 6 | The effect of the mobile game intervention on psychological well-being among menopausal women will be assessed using the Warwick-Edinburgh Mental Well-Being Scale. Total scores range from 14 to 70, with higher scores indicating better mental well-being. Changes in total scores from baseline to Week 6 will be evaluated. |
Countries
Turkey (Türkiye)
Contacts
CONTACTNazire BAHAR
PRINCIPAL_INVESTIGATORNazire BAHAR
Istanbul Universitesi-Cerrahpasa
Outcome results
None listed