The Effect of a Single Session of 30-Minute Mindful Breathing in Reducing Fatigue Among Patients With Haematological Cancer - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Fatigue severity by unidimensional visual analogue scale
研究概览
简要总结
Investigators conducted a parallel-group, non-blinded, randomised control trial at the haemato-oncology unit of University Malaya Medical Centre, from 1st October 2019 to 31st May 2020. Patients included were ≥ 18 years, had histopathological diagnosis of haematological cancer, and fatigue score of ≥ 4 based on the fatigue subscale of Edmonton Symptom Assessment System (ESAS). Patients allocated to the intervention group received standard care plus a guided 30-minute mindful breathing session, while those in control group received standard care. The study outcomes include fatigue severity according to the fatigue subscale of ESAS, visual analogue scale of 0 - 10, and Functional Assessment of Chronic Illness Therapy Fatigue Scale Version 4, at minute 0 and minute 30.
详细描述
Investigators conducted a parallel-group, non-blinded, randomised control trial at the haemato-oncology unit of University Malaya Medical Centre (UMMC), a tertiary university hospital with 1,617 beds in Kuala Lumpur, capital of Malaysia, from 1st October 2019 to 31st May 2020. Patients included were aged 18 years and above, had a histopathological diagnosis of haematological cancer according to World Health Organisation classification, and a fatigue score of ≥ 4 based on the fatigue subscale of Edmonton Symptom Assessment System (ESAS). Patients were excluded if had impaired conscious level, cognitive impairment or any psychiatric illness that would prevent patients from giving informed consent or participate fully in the study; active or past history of cancer of other system, or a haemoglobin level of < 8g/dl.
Procedure:
Patients with haematological cancer attending the haematology clinic or admitted to the haematology ward of UMMC were consecutively screened for eligibility. The demographic and clinical data of the eligible patients, which include age, gender, ethnicity, religion, occupation, education level, marital status, type of haematological cancer, current status of cancer, types of cancer treatment, duration of cancer, blood parameters and other co-morbidities were obtained from the hospital Electronic Medical Record System. Any missing information was obtained by face-to-face interview with patients or relatives.
Patients who satisfied the inclusion criteria and agreed to participate in the study were randomly assigned into 2 groups based on computer-generated random numbers, in blocks of 10, with a one-to-one allocation ratio. Allocation sequence was concealed with sealed envelopes to prevent selection bias. Patients allocated to the intervention group received standard care plus a guided 30-minute mindful breathing session which consisted of four breathing exercises done consecutively in one-to-one manner. The four exercises included identifying the in-and out-breath, following the entire length of the breath, bringing the mind back to the body and relaxing the whole body. Each exercise lasted 7.5 minutes. Guidance was given by one of the two research assistants, who were medical doctors. The research assistants were trained by one of the co-investigators, who was a palliative care physician, certified in mindfulness training.
The training included a brief introduction to the basic concepts of mindfulness, followed by a 30-minute mindful breathing session guided by the trainer. Guidance on delivering the intervention with attention to paralanguage (intonation, rate and rhythm of speech, pitch, articulation, use of silence, etc.) and body language (eye contact, facial expression, posture and bodily movement), followed by supervision of the actual delivery of the 30-minute mindful breathing session by each research assistant were performed. The instructions for the 30-minute mindful breathing are presented in Table 1. Patients in the control group received standard care alone. Patients were allowed to resume usual activities 30 minutes prior to further assessment. Regardless of whether in intervention or control group, patients recruited in out-patient clinic were in sitting position, while patients recruited in ward were in lying position during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 years and above
- •had a histopathological diagnosis of haematological cancer according to World Health Organisation classification
- •a fatigue score of ≥ 4 based on the fatigue subscale of Edmonton Symptom Assessment System
排除标准
- •impaired conscious level
- •cognitive impairment or any psychiatric illness that would prevent patients from giving informed consent or participate fully in the study
- •active or past history of cancer of other systems
- •a haemoglobin level of < 8g/dl
结局指标
主要结局
Fatigue severity by unidimensional visual analogue scale
时间窗: 30-minute
Fatigue severity according to the unidimensional visual analogue scale. The analogue scale range 0 - 10, the higher indicates the worst fatigue.
Fatigue severity by Edmonton Symptom Assessment System
时间窗: 30-minute
Fatigue severity according to the tiredness subscale of Edmonton Symptom Assessment System. The scale range 0 (no tiredness) to 10 (worst possible tiredness). The higher the value indicates the more tiredness/fatigue.
Fatigue severity by Functional Assessment of Chronic Illness Therapy Fatigue Scale Version 4
时间窗: 30-minute
Fatigue severity according to the the score of Functional Assessment of Chronic Illness Therapy Fatigue Scale Version 4. This Scale has 13 items, each item range from 0 (not at all) to 4 (very much). The total score range from 0 to 52, the higher indicates more fatigue.
次要结局
- General feedback(30-minute)
