COMplementary Hand-foot Massage to Improve Experience of illneSs Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 102
- 主要终点
- Change from baseline in quality of life as assessed by EuroQol-5D-L3 (EQ-5D-L3) questionnaire
研究概览
简要总结
The COMplementary hand-foot Massage to Improve experience of ilneSs trial (COMMIS trial) is a prospective, randomized trial and executed at a Western referral Centre: Zuyderland Medical Centre located Sittard-Geleen, The Netherlands concerning patients who underwent surgery for gastrointestinal malignancy. During 5 consecutive days, the intervention group received postoperatively hand-foot massage administered by trained volunteers.
The aim of this study is to investigate the effect of complementary therapies concerning quality of life, pain, nausea, fatigue, sleeping problems, mood and stress in patients who underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal).
详细描述
The COMplementary hand-foot Massage to Improve experience of ilneSs trial (COMMIS trial) is a prospective, randomized trial and executed at a Western referral Centre: Zuyderland Medical Centre located Sittard-Geleen, The Netherlands.
The aim of this study is to investigate the effect of complementary therapies concerning quality of life, pain, nausea, fatigue, sleeping problems, mood and stress in patients who underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal). Patients had to be >18 years of age. Exclusion criteria were patients who were not able to undergo massage, not able to sign informed consent or speaking the native language, deaf patients and patients having a hand- or foot disorder.
Primary outcome measure is quality of life, including psychological state, level of functioning in daily life and pain. Secondary outcome measures are patient satisfaction about the received hospital care and the need for complementary medicine.
Recruitment takes place during the second preoperative appointment at the clinic, where eligible patients receive oral and written information about the study. One week after this conversation, patients are asked if they are interested to participate. If so, informed consent is obtained and remaining questions are answered.
Randomization takes place by the randomization program ALEA. It was not possible to blind investigator, patient, physician or nurse.
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
- •Patients who underwent an operation as a result of gastrointestinal malignancy (stomach or colorectal).
- •Patients >18 years of age.
排除标准
- •Patients who were not able to undergo massage
- •Patients who were not able to sign informed consent
- •Patients who did not speak the native language
- •Deaf patients
- •Patients having a hand- or foot disorder.
研究组 & 干预措施
Therapy standard
Patients receive usual postoperative care
干预措施: Usual post-operative care (Other)
Therapy standard + hand-foot massage
Patients receive usual postoperative care and hand-foot massage
干预措施: Usual post-operative care (Other)
Therapy standard + hand-foot massage
Patients receive usual postoperative care and hand-foot massage
干预措施: Hand-foot massage (Other)
结局指标
主要结局
Change from baseline in quality of life as assessed by EuroQol-5D-L3 (EQ-5D-L3) questionnaire
时间窗: From day of surgery until policlinical visit after hospital's discharge assessed up to 4 weeks
To assess health-related quality of life, patients were asked to fill in the short generic EQ-5D-L3 questionnaire. Patients have to fill in those questionnaires at certain moments in time, from the day of surgery until the first visit at the policlinic after hospital's discharge. Patients are hospitalized about 1-2 weeks and their first policlinical visit after discharge is most often set at 1-2 weeks. That's why the time frame is estimated at 4 weeks. This questionnaire comprises health-related quality of life questions, e.g. state of mobility, self-care, daily activities, mood and pain.
Change from baseline in anxiety and depression as assessed by Hospital Anxiety and Depression Scale (HADS) questionnaire
时间窗: From day of surgery until policlinical visit after hospital's discharge assessed up to 4 weeks
Anxiety and depression is measured by using the Hospital Anxiety and Depression Scale (HADS). Patients have to fill in those questionnaires at certain moments in time, from the day of surgery until the first visit at the policlinic after hospital's discharge. Patients are hospitalized about 1-2 weeks and their first policlinical visit after discharge is most often set at 1-2 weeks. That's why the time frame is estimated at 4 weeks.
次要结局
- Patients' opinion and need about hand-foot massage's utility as assessed by questionnaire(From day of surgery until policlinical visit after hospital's discharge assessed up to 2 weeks)
- Patient satisfaction about the received hospital care and hand-foot massage (if applicable) as assessed by questionnaire(From day of surgery until hospital's discharge assessed up to 2 weeks)
研究者
M.J.M.T. Wolters
Dr. J.H.M.B. Stoot
Zuyderland Medisch Centrum