| CTRI Number |
CTRI/2025/05/087328 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Guided Imagery-Psychological ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of Guided imagery intervention on reducing Stress , Anxiety, Depression and enhancing Psychological well being of adolescent participants from schools in Goa |
|
Scientific Title of Study
|
The Efficiency of Nurse led Guided Imagery on Stress , Anxiety, Depression (SAD) and Psychological well being of Adolescents from selected schools in Goa |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Olinda Toscano |
| Designation |
Tutor |
| Affiliation |
Goa University, Indian Nursing Council |
| Address |
Institute of Nursing Education, Bambolim, Goa
North Goa
GOA
403108
India |
| Phone |
09823852170 |
| Fax |
|
| Email |
toscanoolindafatima@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anita David |
| Designation |
Professor and Head of department of Paediatric Nursing |
| Affiliation |
Government of Tamilnadu, Indian Nursing Council , |
| Address |
Sri Ramachandra College of Nursing,
Sri Ramachandra Institute of Higher Education and Research,
Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
09444523496 |
| Fax |
|
| Email |
anitadavid@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Olinda Toscano |
| Designation |
Tutor |
| Affiliation |
Goa University, Indian Nursing Council |
| Address |
Institute Of Nursing Education, Bambolim
North Goa
GOA
403108
India |
| Phone |
9823852170 |
| Fax |
|
| Email |
toscanoolindafatima@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Don Bosco High School and Higher Secondary School, Panaji, Goa |
| Dr. K.B.Hegdewar High School and Higher Secondary School, Cujira, Bambolim,Goa |
| Fr. Agnel High School and Higher Secondary School, Pilar , Goa |
| Fr. Agnel Multipurpose School and higher secondary School, Verna, Goa |
| Infant Jesus high School and Higher Secondary School, Colva, Goa |
| Our Lady of Perpetual Succour High School and Higher Secondary School, Cortalim,Goa |
| St. Andrews High School and Higher Secondary School, Vasco,Goa |
| St. Michaels High School and Higher Secondary School, Taleigao, Goa |
|
|
Primary Sponsor
|
| Name |
Olinda Toscano |
| Address |
H.No.159
Velsao
P.O.Cansaulim
Goa |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Institute of Nursing Education |
Bambolim, Goa |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Olinda Toscano |
Don Bosco high School and Higher Secondary school |
Panaji
North Goa
GOA |
9823852170
olindatoscano18@gmail.com |
| Ms Olinda Toscano |
Dr. K.B. Hegdewar High school and Higher secondary school |
Cujira, Bambolim
North Goa
GOA |
9823852170
olindatoscano18@gmail.com |
| Ms Olinda Toscano |
Fr. Agnel High School and Higher Secondary School |
Pilar
North Goa
GOA |
9823852170
olindatoscano18@gmail.com |
| Ms Olinda Toscano |
Fr. Agnel Multipurpose High School and Higher Secondary School |
Verna
South Goa
GOA |
9823852170
olindatoscano18@gmail.com |
| Ms Olinda Toscano |
Infant Jesus High School and Higher Secondary School |
Colva
South Goa
GOA |
9823852170
olindatoscano18@gmail.com |
| Ms Olinda Toscano |
Our Lady of Perpetual Succour High School and Higher Secondary School |
Cortalim
South Goa
GOA |
9823852170
olindatoscano18@gmail.com |
| Ms Olinda Toscano |
St. Andrews high school and higher secondary school |
Vasco
South Goa
GOA |
9823852170
olindatoscano18@gmail.com |
| Ms Olinda Toscano |
St. Michaels high School and Higher Secondary school |
Taleigao
North Goa
GOA |
9823852170
olindatoscano18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Directorate of Health Services, Goa |
Approved |
| Institutional Ethics Committee Sri Ramachandra Institute of Higher Education and Research |
Approved |
| Permission from school 1 |
No Objection Certificate |
| Permission from school 10 |
No Objection Certificate |
| Permission from school 2 |
No Objection Certificate |
| Permission from school 3 |
No Objection Certificate |
| Permission from school 4 |
Approved |
| Permission from school 5 |
No Objection Certificate |
| Permission from school 6 |
No Objection Certificate |
| Permission from school 7 |
No Objection Certificate |
| Permission from school 8 |
No Objection Certificate |
| Permission from school 9 |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Behavioural and emotional disorders with onset occuring in childhood and adolescence (F90-F98) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group -no intervention |
Does not include any intervention. The DASS-21 and SDQ questionnaire will be administered to the other students of schools from which sample is not taken for intervention. Similarly post assessment will also be done at 6 weeks of preassessment.
On humanitarian grounds the intervention will be provided to the participants of the control group on completion of the study with the experimental group |
| Intervention |
Psychological Intervention of Guided Imagery |
This research is proposed as follows-
1. Randomly select 08 schools with higher secondary section.
2. Explain and administer the DASS-21 scale to assess Stress, Anxiety, Depression (SAD) and SDQ to measure psychological wellbeing in students willing to participate in the study. This will be the preassessment .
3. Adolescents having mild and moderate level of stress, anxiety , depression and low psychological wellbeing will be included in the RCT.
4. They will be allocated to the experimental and control group using simple randomization.
5. The Experimental group(E) receives Pre assessment , Guided Imagery and Post assessment and
Control group (C) receives Pre assessment and Post assessment.
6. The Guided Imagery session will be conducted at the school by the researcher for the adolescents
7. The students in the experimental group will be provided information related to Guided Imagery to practice the same regularly .
8. Responses of the experimental and control group adolescents will be evaluated after a period of 6 weeks, 3 months , 6 months using the DASS-21 scale and SDQ to assess the efficiency of the Guided Imagery on symptoms of Stress, Anxiety, Depression (SAD) and the psychological wellbeing.
Guided Imagery- this is a valuable intervention strategy that can benefit children who are at risk for social, academic and mental health problems( Skeens, 2017). This is a technique that employs imagination , emotions and a spectrum of bodily senses(Naparstek, 1994). This particular technique can be applied in community and academic settings to help enhance self efficacy and mental health functioning for adolescents at risk.
The researcher has undergone training in Guided Imagery and uses this intervention which is widely accepted as well as simple and easy to use with the adolescents.
STEPS are as follows:
1. Find a comfortable place to sit or lie down.
2. Ask them to close their eyes, and start by taking a few deep breaths.
3. With each exhalation, allow the tension in their body to release, as they become increasingly relaxed and comfortable.
4. Imagine scenes that are calm and peaceful eg. a beach, a mountain setting, a meadow, or a scene of their choice. Add some details like ocean waves sweeping towards shore, mist of waterfall from the mountain, etc.
5. When they are deep in the scene and are feeling relaxed, take a few minutes to breathe slowly and feel calm.
6. Then, when they are ready, slowly take themselves out of the scene and back to the present.
7. Let them tell themselves that they will feel relaxed and refreshed and will bring their sense of calm with them.
8. Count to 3, and open the eyes
9. Advise to continue breathing smoothly and rhythmically
10.They express how they feel right now.
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
-Not having any concurrent physical illness
-Those who have given their assent and parental consent
-Able to write and read English fluently |
|
| ExclusionCriteria |
| Details |
-Those who have visited the psychologist , psychiatrist, on any medical, psychological treatment, therapy
-Having any neurodevelopmental disorder |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The assessment of these symptoms helps in early identification and treatment of
school going adolescents and decreases the morbidity of mental illness. The findings of this research study
can be effectively used to assess SAD and improve psychological wellbeing of the adolescents through the
school mental health programme with the assistance of the school teachers and management. This technique
can also be used by the school counsellor / teachers to improve adolescent wellbeing |
Guided Imagery intervention will be provided for 4 weeks to the experimental group. Responses of the experimental and control group adolescents will be evaluated after a period of 6
weeks, 3 months , 6 months using the DASS-21 scale and SDQ to assess the efficiency of the
Guided Imagery on symptoms of Stress, Anxiety, Depression (SAD) and the psychological
wellbeing.
children in the conrol group will also be given the intervention after results of experimental group are analysed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This guided imagery intervention is simple and can be used at the school level by teachers and at the state level the counsellors can provide the same through the District Mental Health Program implemented at schools and community level. |
Can help reduce morbidity of Mental illness at an early age as Guided Imagery helps one relax with positive thoughts being stimulated. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
09/06/2025 |
| 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
|
Guided Imagery is a simple effective measure to assist the school going adolescents in their everyday life to overcome symptoms of stress, anxiety, depression and decreased psychological wellbeing in order to prevent mental illness thus decreasing the morbidity of mental illness. India is the second most populous country in the world where every fifth person is an adolescent between 10-19 years. this young population is the future asset for progress of this country provide this population enjoys good physical and mental health. For this study, the population includes adolescents in the age group of 13-17 years studying in Goa Board of Secondary and Higher Secondary Education with attached Higher Secondary Schools. Standardised tools - DASS-21 and Strengths and Difficulty Questionnaire will be self administered to the participants. this includes the preliminary assessment. The target population will be selected through Simple Random Sampling using the table of numbers. Those participants having mild, moderate and severe levels of stress , anxiety , depression and psychological well being will form the target population. The research design is RCT that will include an experimental and control group comprising of 70 participants each. The psychological intervention of Guided Imagery will be given by the PI to the experimental group for 4 weeks after which the same tool will be self administered at 6 weeks , 3 months and 6 months of duration. Those in the control group will also be helped with Guided Imagery once the experimental group follow ups are completed. Results will be obtained using differential and inferential statistics. Those adolescents who continue to have continued levels of stress inspite the Guided Imagery intervention will be referred for medical help. |