| CTRI Number |
CTRI/2024/09/073781 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Brief Psychological Intervention to Improve Professional Quality of Life, Coping Style and Sleep Quality in Emergency Care Providers |
|
Scientific Title of Study
|
Feasibility of a Brief Psychological Group Intervention for Emergency Care Residents and Nurses |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Daksha Dhariwal |
| Designation |
MPhil Clinical Psychology Trainee |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions(MCHP), Manipal Academy of Higher Education (MAHE), Manipal-576 104
Udupi
KARNATAKA
576104
India |
| Phone |
8105842058 |
| Fax |
|
| Email |
daksha.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishalee S |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions(MCHP), Manipal Academy of Higher Education (MAHE), Manipal-576 104
Udupi
KARNATAKA
576104
India |
| Phone |
9488615322 |
| Fax |
|
| Email |
vaishalee.s@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ms Samyukta Vaidyanathan |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions (MCHP) |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions(MCHP), Manipal Academy of Higher Education (MAHE), Manipal-576 104
Udupi
KARNATAKA
576104
India |
| Phone |
8939372782 |
| Fax |
|
| Email |
samyukta.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Infrastructural Support - Manipal Academy of Higher Education, Manipal 576104 |
|
|
Primary Sponsor
|
| Name |
Daksha Dhariwal |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions(MCHP), Manipal Academy of Higher Education (MAHE), Manipal-576 104 |
| 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 Vaishalee |
Kasturba Hospital |
Department of Clinical Psychology, Manipal College of Health Professions(MCHP), Manipal Academy of Higher Education (MAHE), Manipal-576 104
Udupi
KARNATAKA |
9488615322
vaishalee.s@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hosiptal Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Emergency care residents and nurses without any mental disorder as per ICD 10 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief Psychological Group Interventio |
The three-day intervention module is designed to assist emergency care professionals in comprehending and addressing burnout, compassion fatigue, secondary traumatic stress, and compassion satisfaction. Total duration of 3 weeks, with one session per week. Session 1 begins with an icebreaker to establish a safe place, then group discussions, a psychoeducational session covering the main ideas, and a guided body scan meditation to improve mindfulness. After that, they have a quick reflection homework assignment. Session 2 begins with a review of the reflections, then teaches coping methods such emotional, cognitive, behavioural, and grounding approaches, as well as improving sleep hygiene. Along with group brainstorming and an emphasis on secondary traumatic stress (STS), the session ends with a homework assignment to put coping mechanisms into practice. Session 3 sees a change in emphasis to compassion fatigue and compassion satisfaction. Tools to enhance compassion satisfaction and reduce fatigue are sought. Self-narratives and self-care practices will be encouraged. The session ends with a summary of the intervention and resources for ongoing support. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Residents and nurses in emergency medicine settings (6 months - 5 years’ experience), hands on work in emergency medicine settings and willingness to actively participate in the group intervention and adhere to the program requirements for the specified duration.
|
|
| ExclusionCriteria |
| Details |
Participants diagnosed with mental and physical health disorders previously or presently. Participants with conflicting work or personal responsibilities that may interfere with regular attendance. Those currently or in the past 6 months who have participated in other interventions or programs targeting the same outcomes. Participants currently struggling with substance abuse issues. Pregnant individuals.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop a brief psychological group intervention for emergency care residents and nurses to improve their professional quality of life, sleep quality, and coping strategies. |
Intervention is of 3 days; once every week. Assessment as 3 points: pre(baseline)- post intervention and 1 month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To examine the feasibility of a brief psychological group intervention. |
Assessment at 3 points: pre(baseline)- post intervention and 1 month follow up. |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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)
|
26/09/2024 |
| 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="8"
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
|
The aim of the current study is to examine the feasibility of a brief psychological group intervention in improving the professional quality of life, sleep quality and coping strategies among emergency care residents and nurses. The objectives of the study are: a) To develop a brief psychological group intervention for emergency care residents and nurses to improve their professional quality of life, sleep quality, and coping strategies. b) To examine the feasibility of a brief psychological group intervention. 23 emergency care residents and nurses from Kasturba Hospital, Manipal, will be recruited. Since the study is a single group pre-post design, no randomization of participants is involved. Through purposive sampling that satisfy the inclusion and exclusion criteria participants will be recruited. Recruitment will involve informing potential participants about the study, its objectives, and requirements, followed by obtaining informed consent. Data collection will include socio-demographic information and clinical data at baseline, using structured forms. Participants will undergo a brief psychological group intervention spanning three sessions, focusing on coping strategies, secondary traumatic stress, and sleep hygiene. These sessions will be distinct from standard care practices. Assessment visits will occur at pre-intervention, post-intervention, and one-month follow-up. Standardized scales such as the Professional Quality of Life Scale, Brief COPE Scale, and Pittsburgh Sleep Quality Index will be administered to measure outcomes. Session 1 is ‘Understanding and Identifying Challenges (90 minutes)’. Session 2 is ‘Coping Strategies, STS and Sleep Hygiene (90 minutes)’. Session 3 is ‘Compassion satisfaction and compassion fatigue (90 minutes)’. Safety checks will be implemented throughout the intervention, and withdrawal criteria will be defined. Follow-ups may involve telephonic reminders to ensure participant compliance. Overall, the study aims to evaluate the effectiveness of intervention in improving professional quality of life, coping strategies, and sleep quality among emergency care professionals. |