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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- 1. Reduction in perceived stress levels measured using the Perceived Stress Questionnaire.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1. Reduction in perceived stress levels measured using the Perceived Stress Questionnaire.
时间窗: 1. Assessed at baseline (12–24 hours before surgery). | 2. Assessed at baseline (12–24 hours before surgery).
2. Improvement in mental well-being measured using the Warwick-Edinburgh Mental Well-being Scale.
时间窗: 1. Assessed at baseline (12–24 hours before surgery). | 2. Assessed at baseline (12–24 hours before surgery).
次要结局
- 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.)
研究者
Jisha Abraham
Malabar Cancer Centre Postgraduate Institute of Oncology Sciences and Research