| CTRI Number |
CTRI/2025/12/098548 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of psychological problems in patients with Trigeminal Neuralgia |
|
Scientific Title of Study
|
Prevalence rate and Predictors of Psychological Concerns in Patients with Trigeminal Neuralgia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Misbah Sadaf |
| Designation |
Senior Resident |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
3rd floor Faculty Block Department of Neuroanaesthesia and Neurocritical Care National Institue of Mental Health and Neurosciences
Bangalore
KARNATAKA
560029
India |
| Phone |
9845043612 |
| Fax |
|
| Email |
misbahsadaf.a@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia Bansal |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Neuroanaesthesia and Neurocritical Care 3rd floor Faculty Block National Institue of Mental Health and Neurosciences Hosur road Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9008721921 |
| Fax |
|
| Email |
itz.sonia77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Misbah Sadaf |
| Designation |
Senior Resident |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
3rd floor Faculty Block Department of Neuroanaesthesia and Neurocritical Care National Institue of Mental Health and Neurosciences
Bangalore
KARNATAKA
560029
India |
| Phone |
9845043612 |
| Fax |
|
| Email |
misbahsadaf.a@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institue of Mental Health and Neurosciences
Hosur Road Bengaluru 560029 Karnataka India |
|
|
Primary Sponsor
|
| Name |
National Institue of Mental Health and Neuro Sciences |
| Address |
3rd floor Faculty Block Department of Neuroanaesthesia and Neurocritical Care National Institue of Mental Health and Neurosciences
Hosur Road Bengaluru 560029 Karnataka India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Misbah Sadaf |
National Institute of Mental Health and Neuro Sciences |
3rd floor Faculty block Department of Neuroanaesthesia and Neurocritical Care NIMHANS Hosur Road Bengaluru 560029 karnataka India
Bangalore
KARNATAKA |
9845043612
misbahsadaf.a@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institue of Mental Health and Neurosciences(Institue of National Importance |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G50-G59||Nerve, nerve root and plexus disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Trigeminal Neuralgia of more than 6 weeks duration and BNI III, IV and V
2.Patients on at least 2 medications for the treatment of Trigeminal Neuralgia
|
|
| ExclusionCriteria |
| Details |
1.Patients who have already undergone surgery for TN earlier
2.Patients with pre-existing psychiatric disorders
3.Patients with TN secondary to multiple sclerosis
4.Patient with other chronic pain syndromes
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the prevalence of psychological comorbidities, namely anxiety, depression, sleep disturbances, and reduced quality of life, in patients with TN |
At First OPD visit, 1month, 3month and 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify clinical and sociodemographic predictors of psychological comorbidities in patients with Trigeminal Neuralgia |
At First OPD visit, 1month, 3month and 6months |
| To evaluate the impact of different treatment modalities on the prevalence rate of psychological comorbidities by assessing changes in anxiety, depression, sleep disturbances, and quality of life from baseline (at presentation) to one-month, 3 months and 6 months post-treatment. |
At First OPD visit, 1month, 3month and 6months |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
16/12/2025 |
| 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
|
This protocol outlines a prospective observational study at NIMHANS, Bengaluru, that will enroll patients diagnosed with trigeminal neuralgia to investigate the frequency and contributing factors for psychological concerns such as depression, anxiety, sleep disturbances, and impaired quality of life—using validated questionnaires that are PHQ 9, GAD 7, EuroQol 5D, PSQI at initial visit, 1month, 3months and 6months. The research does not involve any invasive procedures or additional risk instead, it aligns follow-up assessments with standard clinical care, with the final follow-up done by telephone to minimize inconvenience. Ethical safeguards are firmly in place, including informed consent, data confidentiality, and provisions for addressing distress identified during screenings. The ultimate goal is to improve awareness and management of psychological comorbidities in trigeminal neuralgia patients through systematic, ethically sound monitoring and identification of predictors. |