| CTRI Number |
CTRI/2018/07/014770 [Registered on: 09/07/2018] Trial Registered Prospectively |
| Last Modified On: |
05/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Comparison of the degree of positiveness attributed to one’s own body and the method which individuals usually follow to make decisions among Tattooed and Non-Tattooed individuals between 18-30 years of age. |
|
Scientific Title of Study
|
A Comparison of Body-esteem and Decision-Making Styles among Tattooed and Non-Tattooed young adults. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Oshin Deshmukh |
| Designation |
Student |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Clinical Psychology, School of Allied Health Sciences, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9769501726 |
| Fax |
|
| Email |
oshdeshmukh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Indu Toby |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Clinical Psychology, School of Allied Health Sciences, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9482784595 |
| Fax |
|
| Email |
indu.toby@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Oshin Deshmukh |
| Designation |
Student |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Clinical Psychology, School of Allied Health Sciences, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9769501726 |
| Fax |
|
| Email |
oshdeshmukh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Moths and Owls Tattoos.
D1, Sanjivani C.H.S., Plot no. 7, above Complete Dental Care, Near Suvidya School/ Maxus Cinema, Gorai 1, Borivali (West), Mumbai (Suburban), Maharashtra |
|
|
Primary Sponsor
|
| Name |
Oshin Deshmukh |
| Address |
Department of Clinical Psychology, School of Allied Health Sciences, Manipal Academy of Higher Education |
| 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 |
| Oshin Deshmukh |
Moths and Owls Tattoos |
D1, Sanjivani C.H.S., Plot no. 7, above Complete Dental Care, Near Suvidya School/ Maxus Cinema, Gorai 1, Borivali (West)
Mumbai (Suburban)
MAHARASHTRA |
9769501726
oshdeshmukh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young adults (18 to 30 years of age) with and without tattoos (body-modifications). |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals should be within the age group of 18-30 years.
2. Individuals should be residents of Mumbai.
3. Individuals should know how to read and write English.
4. Individuals who consent to participate in the study.
5. Individuals with tattoos should either have tattoos at visible places or should be consenting to give a proof of it. |
|
| ExclusionCriteria |
| Details |
1. Individuals with physical impairment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the body-esteem and decision-making styles of young adults with and without tattoos. |
14th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the relationship between body-esteem and decision-making styles of young adults with and without tattoos. |
14th month |
| To study the gender differences in the body-esteem and the decision-making styles. |
14th month |
|
|
Target Sample Size
|
Total Sample Size="555"
Sample Size from India="555"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
09/07/2018 |
| 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="11"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose of the study is to compare the body-esteem and the decision-making styles of young adults with and without tattoos. Whereas, the secondary purposes are as follows: o To study the relationship between body-esteem and decision-making styles of young adults with and without tattoos. o To study the gender differences in the body-esteem and the decision-making styles.
There are 3 hypotheses in this study which are in accord to the primary and the secondary purposes. These hypotheses are as follows: o H0: There is no significant difference in body-esteem and decision-making styles among young adults with and without tattoos. o H0: There is no significant relationship between body-esteem and decision-making styles of young adults with and without tattoos. o H0: There is no significant gender difference in body-esteem and decision-making styles among young adults with and without tattoos. |