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Reducing Stress in Women with Breast Cancer During Surgery: A Study on the Benefits of Psychological Support

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) - EPIP-BC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093821
Enrollment
128
Registered
2025-08-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C50-C50- Malignant neoplasms of breast

Interventions

Intervention1: 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

Sponsors

Malabar Cancer Centre Thalassery
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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. Timepoint: 1. Assessed at baseline (12 24 hours before surgery). 2. Assessed at baseline (12 24 hours before surgery).

Secondary

MeasureTime frame
Feasibility, acceptance, & patient satisfaction of Guided Imagery & Music Therapy.Timepoint: Assessed immediately after the pre-operative session;Variability in response based on age, socioeconomic status, & cancer stage.Timepoint: Assessed post-operatively, 1 2 days after surgery.;Changes in vital signs (heart rate, blood pressure, respiratory rate).Timepoint: Assessed at baseline (12 24 hours before intervention), & immediately after the intervention.

Countries

India

Contacts

Public ContactJisha Abraham

Department of Psychology, SRM University-AP, Andhra Pradesh, India.

ayeshaparveen.h@srmap.edu.in9618873295

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026