| CTRI Number |
CTRI/2023/12/060543 [Registered on: 19/12/2023] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of art therapy on level of anxiety among hospitalised pre school children |
|
Scientific Title of Study
|
Effectiveness of art therapy on level of anxiety among hospitalised pre school children in tertiary hospitals of Gangtok, Sikkim. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Angelina Lepcha |
| Designation |
MSc Nursing student |
| Affiliation |
Indian Nursing Council, Sikkim Nursing Council, NAAC |
| Address |
Sikkim Manipal College of Nursing
5th Mile Tadong Gangtok Sikkim
Room No: 2nd year M.Sc nursing Room
1st floor
East
SIKKIM
737101
India |
| Phone |
9832925553 |
| Fax |
|
| Email |
anzeelucksom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sorokhaibam Nandarani Devi |
| Designation |
Assistant Professor |
| Affiliation |
Sorokhaibam Nandarani Devi |
| Address |
Sikkim Manipal College of Nursing
5th Mile Tadong Gangtok Sikkim
1st floor
Assistant Professors Room
Cabin No: 3
East
SIKKIM
737101
India |
| Phone |
9077396254 |
| Fax |
|
| Email |
sorokhaibam.nd@smcon.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shashirani Pangambam |
| Designation |
Associate Professor |
| Affiliation |
Shashirani Pangambam |
| Address |
Sikkim Manipal College of Nursing
5th Mile Tadong Gangtok Sikkim
1st Floor
Associate Professors Room
Cabin No 5
East
SIKKIM
737101
India |
| Phone |
8967035767 |
| Fax |
|
| Email |
shashirani.p@smims.smu.edu.in |
|
|
Source of Monetary or Material Support
|
| Sikkim Manipal College of Nursing
5th mile Tadong Gangtok |
|
|
Primary Sponsor
|
| Name |
Angelina Lepcha |
| Address |
Sikkim Manipal College of Nursing
5th Mile Tadong Gangtok |
| 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 Meenakshi Dahal |
Central Referral Hospital and STNM Hospital |
Pediatric ward
5th floor
CRH Hospital
Pediatric ward
5th floor
STNM Hospital
East
SIKKIM |
8967924666
meenakshidahal@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS INSTITUITION ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F418||Other specified anxiety disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
art therapy on level of anxiety |
3 sessions for 3 days, 1 session per day , and each session with 30 mins duration. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Children age group 3-6 years who is admitted in pediatric ward.
2. The presence of at least one care giver.
3. Children whose parents or guardians have given informed consent for their participation in the study.
4. Children who has anxiety based on Pre School Anxiety Scale.
|
|
| ExclusionCriteria |
| Details |
1. Children those who are critically and mentally ill. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Art therapy will improve the level of anxiety among pre-schooler hospitalized children.
|
3 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Based on the findings it will help the staff nurse and the students to use this method in practice areas routinely in order to reduce anxiety. |
everyday |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
29/12/2023 |
| 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="1"
Days="15" |
|
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
|
BACKGROUND:
Hospitalization is stressful condition for children of all age groups. Paediatric patients are often subjected to unexpected medical procedures that cause pain,worry, stress and anxiety. Anxiety disorders are more common in pre-schooler.Children who are hospitalized is usually segregated by care requirements or age or by both. Children’s need can be classified under three main headings: Adequate provision of care; protection from any physical danger and protection from a psychologically threatening environment
PURPOSES / OBJECTIVES: 1. To assess the level of anxiety among pre-schoolers who are hospitalized before and after administering art therapy . 2. To determine the effectiveness of art therapy among the pre-schoolers who are hospitalized. 3. To determine the association between the level of anxiety with demographic variables. PROJECTED OUTCOME: 1. Art therapy will improve the level of anxiety among pre-schooler hospitalized children. A Study is done to see the effectiveness of art therapy on reduction of anxiety in pre schooler children during hospitalisation. |