| CTRI Number |
CTRI/2022/11/046985 [Registered on: 02/11/2022] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of interventional package on anger management among alcohol dependence |
|
Scientific Title of Study
|
A study to assess the Effectiveness of interventional package on anger management among alcohol dependence at selected deaddiction centre Puducherry |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MAHALAKSHMI E |
| Designation |
MSc NURSING DEPT OF MENTAL HEALTH NURSING STUDENT |
| Affiliation |
VINAYAKA MISSIONS COLLEGE OF NURSING |
| Address |
VINAYAKA MISSIONS COLLEGE OF NURSING KIRUMAMPAKKAM PONDICHERRY
VINAYAKA MISSIONS COLLEGE OF NURSING KIRUMAMPAKKAM PONDICHERRY
Pondicherry
PONDICHERRY
607403
India |
| Phone |
09791274435 |
| Fax |
|
| Email |
mahaselva2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAROJINI S |
| Designation |
ASSOCIATE PROFESSOR DEPARTMENT OF OBG |
| Affiliation |
VINAYAKA MISSIONS COLLEGE OF NURSING |
| Address |
VINAYAKA MISSIONS COLLEGE OF NURSING KIRUMAMPAKKAM PONDICHERRY
VINAYAKA MISSIONS COLLEGE OF NURSING KIRUMAMPAKKAM PONDICHERRY
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8940000434 |
| Fax |
|
| Email |
sarojini.sai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MAHALAKSHMI E |
| Designation |
MSc NURSING DEPT OF MENTAL HEALTH NURSINGSTUDENT |
| Affiliation |
VMCON |
| Address |
VINAYAKA MISSIONS COLLEGE OF NURSING CONSTITUENT COLLEGE OF VINAYAKA MISSIONS RESEARCH FOUNDATION KIRUMAMPAKKAM PONDICHERRY
VINAYAKA MISSIONS COLLEGE OF NURSING,CONSTITUENT COLLEGE OF VINAYAKA MISSIONS RESEARCH FOUNDATION KIRUMAMPAKKAM PONDICHERRY
Pondicherry
PONDICHERRY
607403
India |
| Phone |
09791274435 |
| Fax |
|
| Email |
mahaselva2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| BHARATHA MATHA DEADDICTION CENTRE PUDUCHERRY |
|
|
Primary Sponsor
|
| Name |
SELF FUNDED |
| Address |
VINAYAKA MISSIONS COLLEGE OF NURSING AARUPADAI VEEDU MEDICAL COLLEGE CAMPUS KIRUMAMPAKKAM PONDICHERRY PNY IN |
| Type of Sponsor |
Other [SELF FUNDED BY THE INVESTIGATER] |
|
|
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 |
| Mahalakshmi E |
Bharathamatha Deaddiction center |
ARIYANKUPPAM PONDICHERRY
Pondicherry
PONDICHERRY |
09791274435
mahaselva@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (HUMAN STUDIES) VINAYAKA MISSIONS OF COLLEGE OF NURSING PUDUCHERRY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ON ANGER MANAGEMENT |
Pre-test level of anger will be assessed by Clinical Anger Scale and Participants data will be collected by the structured questionnaire. Interventional Package on Anger management will be demonstrated to the Alcohol dependence for fifteen days.Twenty –thirty minutes for instrument administration and thirty to forty- five minutes for intervention schedule.Researcher will be ensured that the each participants will be practiced the same interventional package on anger management for two weeks under the supervision of investigator After two weeks post-test will be conducted by using the same tool which was used in the pre-test.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Alcohol dependence who are
• Age group from 20 to 60 years old
• Able to read and write in Tamil.
• Undergoing deaddiction treatment
• Willing to participate and able to follow the
instructions.
|
|
| ExclusionCriteria |
| Details |
Alcohol dependence who are
• Associated with other substance abuse disorders.
• Female with alcohol dependence
• Non adherent to treatment and having uncontrolled
Blood Pressure
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Providing anger management techniques to alcohol dependence might help to
lower anger and conflicts that would alter the negative effects of anger and there by prevent alcohol consumption. |
AFTER 2 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To modify the behavior of anger in alcohol dependence which helps them to prevent the negative effect of anger and alcohol consequences. |
AFTER 2 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/11/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a pre-experimental one group pretest –post-test study to assess the effectiveness of interventional package on anger management among alcohol dependence at selected deaddiction center, Puducherry. The sample includes alcohol dependence who are full filling the inclusion criteria. Convenience sampling technique will be used to select the samples.The sample size for the study is 60 participants.A written informed consent will be obtained from the study participants.Pre-test level of anger will be assessed by Clinical Anger Scale and Participants data will be collected by the structured questionnaire. Interventional Package on Anger management which includes , Breathing exercise Anger management techniques, Meditation will be demonstrated to the Alcohol dependence . Researcher will be ensured that the each participants will be practiced the same interventional package on anger management for two weeks under the supervision of investigator. After two weeks post-test will be conducted by using the same tool which was used in the pre-test.The collected data will be complied for data analysis |