| CTRI Number |
CTRI/2026/01/101423 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Virtual Reality Based Therapy on Memory Thinking Ability and Mental Well Being in Perimenopausal Women |
|
Scientific Title of Study
|
Effect of virtual reality based intervention on memory executive function and associated mental health in perimenopausal women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashim |
| Designation |
Postgraduate Student |
| Affiliation |
SGT University |
| Address |
SGT University Budhera Gurugram Badli Road Gurugram 122505 Haryana India
Gurgaon
HARYANA
122505
India |
| Phone |
8054509389 |
| Fax |
|
| Email |
wattsrashim999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankita R Parkhe |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
SGT University Budhera Gurugram Badli Road Gurugram 122505 Haryana India
Gurgaon
HARYANA
122505
India |
| Phone |
9049398029 |
| Fax |
|
| Email |
ankita_sphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Rashim |
| Designation |
Postgraduate Student |
| Affiliation |
SGT University |
| Address |
SGT University Budhera Gurugram Badli Road Gurugram 122505 Haryana India
Gurgaon
HARYANA
122505
India |
| Phone |
8054509389 |
| Fax |
|
| Email |
wattsrashim999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rashim |
| Address |
SGT University hospital Gurugram Haryana |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rashim |
SGT University and Research Institute |
SGT University Department of Physiotherapy Room no 403 Block B Gurugram Haryana 122505
Gurgaon
HARYANA |
8054509389
wattsrashim999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Faculty of Physiotherapy SGT University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F09||Unspecified mental disorder due toknown physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cognitive training education
Deep Breathing exercises |
Cognitive education
Habit of taking notes on important matters
Save it on your phone
Habit of putting things in the same place
Focus on one thing
While concentrating move to a quiet place and deal with it
Prepare in advance and practice loudly before the meeting
Listen carefully and follow the story
Mental arithmetic
Memorizing well-known sayings
Eat food that helps brain |
| Intervention |
Virtual reality meta quest 2 device |
Beat saber
Memory on and etc
These games will be played by the individuals for 2 times per week with each session lasting for 40 minutes with 10 mins of warm up and cool down
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women under the age of sixty
Amenorrhoea lasting more than 60 days variations of more than 7 days in consecutive cycles or fewer than one menstrual period in the previous 12 months straw criteria
Individuals who lead sedentary lives
Well-educated individuals at least literate |
|
| ExclusionCriteria |
| Details |
Individuals with any neurological disorders such as seizures or Parkinson disease were excluded
Participants who were current or past smokers were not considered
Those person with chronic medical conditions including hypertension diabetes kidney disease endocrine disorders or nutritional deficiencies were excluded
Individuals with a history of cardiovascular disease were not included
Participants who are taking anti-anxiety or antidepressant medications were excluded
Women who had received menopausal hormone replacement therapy within the past six months or had incomplete clinical information were excluded
Participants with physical impairments affecting reading hearing or comprehension of written or verbal instructions were not eligible
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Memory
Executive Function
Anxiety
Stress
Depression
|
Baseline and 4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Need of the study
With increasing life expectancy a growing proportion of women spend a substantial period of their lives in the perimenopausal stage underscoring the need to address the cognitive and psychological challenges associated with this transition Perimenopausal women frequently experience impairments in memory and executive functions along with heightened susceptibility to anxiety depression and stress due to fluctuating hormonal levels Conventional management strategies including hormone replacement therapy and pharmacological treatments are often constrained by potential adverse effects and limited accessibility Although psychological interventions can be effective their reliance on continuous availability of trained professionals reduces their practicality for widespread use In recent years virtual reality based interventions have emerged as a promising non pharmacological approach offering immersive and interactive environments that support neuroplasticity improve cognitive performance and aid in the management of mood disturbances However evidence evaluating the effectiveness of virtual reality interventions specifically in perimenopausal women remains scarce Therefore the present study aims to address this gap by investigating the effects of virtual reality based interventions on memory executive function and mental health that includes the depression anxiety and stress thereby contributing to the development of innovative and accessible rehabilitation strategies for women during the perimenopausal phase |