| CTRI Number |
CTRI/2025/08/093821 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Reducing Stress in Women with Breast Cancer During Surgery: A Study on the Benefits of Psychological Support |
|
Scientific Title of Study
|
Effectiveness of Psychological Interventions to Manage Perceived Stress among Breast Cancer Patients Undergoing Surgery at a Tertiary Cancer Centre: A Randomised Controlled Trial (EPIP-BC Trial) |
| Trial Acronym |
EPIP-BC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jisha Abraham |
| Designation |
Lecturer in Psycho Oncology |
| Affiliation |
Malabar Cancer Centre Postgraduate Institute of Oncology Sciences and Research |
| Address |
Division of Psycho Oncology, Malabar Cancer Centre, Postgraduate Institute of Oncology Sciences and Research
Kannur
KERALA
670103
India
Kannur
KERALA
670103
India |
| Phone |
8891944401 |
| Fax |
|
| Email |
jishasarah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ayesha Parveen Haroon |
| Designation |
Assistant Professor & Head |
| Affiliation |
Department of Psychology, SRM University-AP, Andhra Pradesh, India. |
| Address |
Department of Psychology,
Easwari School of Liberal Arts,
SRM University-AP,
Amaravati, Andhra Pradesh
Guntur
ANDHRA PRADESH
522240
India |
| Phone |
9618873295 |
| Fax |
|
| Email |
ayeshaparveen.h@srmap.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Jisha Abraham |
| Designation |
Lecturer in Psycho Oncology |
| Affiliation |
Malabar Cancer Centre Postgraduate Institute of Oncology Sciences and Research |
| Address |
Division of Psycho Oncology, Malabar Cancer Centre, Postgraduate Institute of Oncology Sciences and Research
Kannur
KERALA
670103
India
Kannur
KERALA
670103
India |
| Phone |
8891944401 |
| Fax |
|
| Email |
jishasarah@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM University AP, Department of Psychology, Amaravati, Andhra Pradesh, India, PIN – 522240 |
|
|
Primary Sponsor
|
| Name |
Malabar Cancer Centre Thalassery |
| Address |
Malabar Cancer Centre Postgraduate Institute of Oncology Sciences and Research Moozhikkara P O Thalassery Kannur Kerala India 670103 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Jisha Abraham |
Malabar Cancer Centre, Thalassery |
Division of Psycho Oncology, Malabar Cancer Centre, Postgraduate Institute of Oncology Sciences and Research, Kannur, Kerala, 670103, India
Kannur
KERALA |
8891944401
jishasarah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Malabar Cancer Centre, Thalassery |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guided Imagery with Music (Raag Yaman Kalyan) |
The total duration of the intervention is 30–35 minutes. It consists of a single preoperative session of Guided Imagery and Music Therapy using Raag Yaman Kalyan, conducted 12–24 hours before surgery. |
| Comparator Agent |
Standard Care |
Routine preoperative care as per hospital protocol without psychological intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18 to 60 years, scheduled for breast cancer surgery under general anesthesia, able to read and understand English or Malayalam, diagnosed with stage I to III breast cancer, cognitively capable of completing questionnaires, with a Perceived Stress Questionnaire score of twenty-six or above and a Warwick Edinburgh Mental Wellbeing Scale score of forty or below
|
|
| ExclusionCriteria |
| Details |
Patients with advanced disease or in palliative care. Patients on psychotropic medication. Patients receiving non-routine psycho-oncology consultations. Patients with recent alcohol or tobacco use or nicotine therapy. Patients with a psychiatric history or prior psychological interventions. Patients with severe comorbidities or neurological disorders. Patients who are bedridden or unable to sit upright. Patients on high-dose sedatives or opioids. Patients with severe cognitive impairment or unstable vital signs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in perceived stress levels measured using the Perceived Stress Questionnaire.
2. Improvement in mental well-being measured using the Warwick-Edinburgh Mental Well-being Scale.
|
1. Assessed at baseline (12–24 hours before surgery).
2. Assessed at baseline (12–24 hours before surgery). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Feasibility, acceptance, & patient satisfaction of Guided Imagery & Music Therapy. |
Assessed immediately after the pre-operative session |
| Variability in response based on age, socioeconomic status, & cancer stage. |
Assessed post-operatively, 1–2 days after surgery. |
| Changes in vital signs (heart rate, blood pressure, respiratory rate). |
Assessed at baseline (12–24 hours before intervention), & immediately after the intervention. |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
22/09/2025 |
| 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 Yet Recruiting |
| 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
|
This randomised controlled trial will evaluate the effectiveness of psychological interventions, including Guided Imagery and Music Therapy with Indian Classical Raaga Yaman Kalyan, in reducing perceived stress among breast cancer patients undergoing surgery at a tertiary cancer centre. The primary hypothesis is that structured psychological interventions will significantly lower stress levels and improve mental well-being compared with standard care. Eligible patients will be randomly assigned to intervention and control groups, and outcomes will be assessed using validated psychological scales. |