| CTRI Number |
CTRI/2024/10/075289 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study about body compassion and appearance anxiety affecting the quality of life in adult women with acne. |
|
Scientific Title of Study
|
Role of Body Compassion and Social Appearance Anxiety on Quality of Life in Adult females with Acne |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreya Kishanthini Sundar |
| Designation |
MSc Clinical Psychology Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, MAHE, Manipal,
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9600110154 |
| Fax |
|
| Email |
shreya8.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Aparna Daga |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, MAHE, Manipal,
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9748655646 |
| Fax |
|
| Email |
daga.aparna@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shreya Kishanthini Sundar |
| Designation |
MSc Clinical Psychology Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, MAHE, Manipal,
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9600110154 |
| Fax |
|
| Email |
shreya8.mchpmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, MAHE, Manipal, Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Shreya Kishanthini Sundar |
| Address |
Department of Clinical Psychology, Manipal College of Health
Professions, MAHE, Manipal,
Udupi, Karnataka, 576104 |
| 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 |
| Dr Smitha Prabhu S |
Kasturba Hospital |
Room 21, Department of Dermatology, Kasturba Hospital, Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9448910972
smitha.prabhu@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with Acne visiting the Dermatology OPD for the first time, not undertaking previous treatment for more than a month
2. Presence of Acne for at least 6 months, with no significant improvement |
|
| ExclusionCriteria |
| Details |
1. Presence of other dermatological conditions involving the face
2. People with psychiatric illness
3. People undertaking psychiatric medication and/or structured psychological intervention
4. Pregnant women
5. Patients with primarily acne scarring |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the impact of Body Compassion and Social appearance Anxiety on Quality of life |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To understand whether Body compassion plays a role in reducing Social Appearance Anxiety in Female Adults with Acne |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
26/10/2024 |
| 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="0"
Months="9"
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
|
Aim and objectives of the study: 1. 1. To
study Body compassion and Social Appearance Anxiety 1. 2. To understand the role played by Social Appearance Anxiety and Body
compassion on the Quality of Life of participants with acne.
The study duration is from March 2024 to March 2025. The Dermatology department and Clinical Psychology department of Kasturba Hospital will be involved in the study. |