Massage Therapy and Labour Outcomes; A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- The primary outcome is time to use of epidural analgesia measured as cervical dilatation at the time of epidural insertion.
研究概览
简要总结
OBJECTIVE: To measure the benefits of massage, administered by a registered massage therapist, to pain management for women in active labour.
DESIGN: A randomized controlled trial.
SETTING: BC Women's Hospital, a tertiary level maternity teaching hospital in Vancouver, British Columbia, Canada.
PARTICIPANTS: Healthy first time mothers experiencing an uncomplicated pregnancy who present to the hospital in labour. Seventy women will be enrolled in each trial arm.
MAIN OUTCOME MEASURES: The primary outcome is time to use of epidural analgesia measured as cervical dilatation at the time of epidural insertion. Secondary outcomes include use of epidural and narcotic analgesia, and measures of intensity and characteristics of pain.
DATA ANALYSIS: Study outcomes will be compared among women randomized to receive a maximum of five hours of massage during labour administered by a registered massage therapist versus usual care. Analysis will be by intention to treat. Prognostics factors not balanced between trial arms (massage and usual care) will be controlled for in a multivariate analysis.
详细描述
Goal and Objectives:
The overall purpose of this project is to evaluate the effectiveness of massage therapy provided by registered massage therapists in managing pain among women in active labour.
Specific Aims:
Our specific aim is to randomly assign women admitted to hospital in active labour to receive a maximum of five hours massage by a regulated massage therapist or usual care in order to study the effect of massage therapy on pain relief, labour management and patient outcomes.
Research Questions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy primiparous women
- •Nulliparous
- •Singleton gestation
- •Cephalic presentation
- •Term gestation (37-41 completed weeks of pregnancy)
- •Maternal age between 18 and 35 years of age
- •In spontaneous labour, defined for our purposes as painful contractions which have resulted in cervical change, i.e. cervix is 1 cm dilated or more with effacement at 25% (0.5 cm) or more on admission to the labour unit
- •Able to speak and read English or speak a language for which there is a nursing interpreter available
- •Exclusion Criteria
- •Pre-existing medical conditions including but not limited to: insulin dependent diabetes, renal, cardiac, or thyroid conditions, hypertension, epilepsy, psychosis, use of illicit street drugs
- •Conditions arising during pregnancy which require non-routine surveillance and/or intervention including but not limited to gestational diabetes, gestational hypertension, 2nd or 3rd trimester hemorrhage, intrauterine growth restriction, presence of a fetal congenital anomaly, history of preterm prelabour rupture of membranes
- •Statement by women on admission that she has been in labour for more than 24 hours
- •Cervical dilatation 10 cm (full dilatation) on admission to the labour ward
排除标准
- 未提供
结局指标
主要结局
The primary outcome is time to use of epidural analgesia measured as cervical dilatation at the time of epidural insertion.
时间窗: During labour
次要结局
- Secondary outcomes include use of epidural and narcotic analgesia and measures of intensity and characteristics of pain.(During labour)