NCT07800793

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2027

Last Updated

September 17, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 30, 2026

Last Update Submit

September 14, 2026

Conditions

Keywords

menopausebrain fogpsychological well-being

Outcome Measures

Primary Outcomes (1)

  • Brain fog

    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).

    Baseline and Week 6

Secondary Outcomes (1)

  • Change in Warwick-Edinburgh Mental Well-Being

    Baseline and Week 6

Study Arms (2)

Menopause Mobile Game Intervention

EXPERIMENTAL

Participants will use a mobile game developed to address brain fog symptoms during menopause.

Behavioral: Menopause Mobile Game

Routine Care Control

NO INTERVENTION

Participants will receive routine care and will not use the mobile game during the study period.

Interventions

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.

Also known as: Menopause Education and Self-Management Mobile Game
Menopause Mobile Game Intervention

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Medipol University Mega Hospital

Istanbul, Mrs, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mental FatiguePsychological Well-Being

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Nazire BAHAR

    Istanbul Universitesi-Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 30, 2026

First Posted

September 2, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

December 15, 2027

Last Updated

September 17, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be publicly shared because the study involves sensitive health-related information collected from participants. Data will be used solely for the purposes of this research and will be reported in aggregate form to protect participant confidentiality.

Locations