Promoting Self-efficacy and Social Support to Enable Women to Reduce the Risks of Pelvic Organ Prolapse Related to Heavy Lifting in a Non-randomized Controlled Trial With a 3-arm Parallel Intervention Group Design in Rural Nepal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Self-reported carried weight at follow up
研究概览
简要总结
The Women Lift Safely! Intervention study aims to increase safe carrying behavior to reduce health risks of heavy lifting in a rural area of Nepal (i.e. reducing weight and using safe lifting techniques).
The study's specific aims are to:
- Test whether a psychological intervention that promotes self-efficacy can promote women's use of safe carrying behavior effectively compared to an information only control condition.
(2) Test whether including a social partner in the intervention is more effective than an individual psychological intervention.
详细描述
Background
The frequent carrying of heavy loads bears health risks for women in low- and middle-income countries, such as Nepal (Geere et al. 2018,2020; Koyucu et al., 2021; Walker & Gunasekera, 2011).
To prevent the physical health impacts of carrying heavy loads, e.g. pelvic organ prolapse, research has shown that preventive behaviors in terms of applying safe carrying behaviors can enable women to minimize adverse health outcomes:
- Reducing the carried load, especially during pregnancy and postpartum (Darshan, 2009; Koyucu et al., 2021; MacDonald et al., 2013; Oxford University Hospitals, 2016; Sharma, 2012; SUVA, the Swiss National Accident Insurance Fund, 2019)
- Using safe lifting techniques (exhale, tighten pelvic floor and use a safe body posture when lifting load) (Caagbay et al., 2020; Hagins et al., 2004)
In a preliminary study, the investigators identified low self-efficacy (belief in the own capability to engage in healthy behavior) and insufficient social support (emotional, practical or informational assistance by social partner) as reasons for risky carrying behavior (Tomberge et al., 2021).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The assignment of groups to the villages will be random (drawing lots by a person not included in the research team). All participants from one village will receive the same intervention. Participants are blinded to condition. Enumerators cannot be blinded to condition, but the specific intervention assignment is concealed until the arrival at the intervention site. In a debriefing after the follow up interviews, the allocated intervention group will be revealed to the participants.
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Self-reported carried weight at follow up
时间窗: 8 weeks after intervention
Carried weight will be assessed through the sum of two self-reported items referring to the weight carried in the last week. Open answers in kg. "In the last 7 days, what was the usual weight of water you carried per trip?" "In the last 7 days, what was the usual weight of other loads (e.g. grass, fodder, firewood you carried per trip?"
Index of self-reported safe lifting techniques during performance at follow up
时间窗: 8 weeks after intervention
An index of safe lifting will be calculated by the product of a safe lifting score x self-reported frequency of using safe-lifting techniques, ranging from 0 (= never uses safe lifting techniques) to 7 (= always uses safe lifting techniques) Score: The participants will be asked to lift a water-filled container at the size they usually carry. Lifting techniques will then be assessed through two self-reported items, e.g.: "What did you do with your pelvic floor during lifting?" 1 = "Tightening"; 0 "Relax"; 0 "did not feel the pelvic floor"; 0 = "I don't know"; 0 = "other". The safe lifting score is calculated by summing the points of the two items, thus ranging from 0 (= unsafe lifting) to 2 (= safe lifting). Frequency: Average of two items "In the last 7 days, how often did you tighten your pelvic floor when lifting loads?"; "In the last 7 days, how often did you exhale when lifting loads?" Answer options 1 = ((Almost) never (0%)) to 5 (= (Almost) always (100%)).
次要结局
- Self-reported pain(8 weeks after intervention)
- Self-reported outcome expectancies to reduce carried weight(8 weeks after intervention)
- Self-reported symptoms of pelvic organ prolapse(8 weeks after intervention)
- Self-reported self-efficacy to reduce carried weight during prospective pregnancies / postpartum(8 weeks after intervention)
- Self-reported intention to use safe lifting techniques(8 weeks after intervention)
- Self-reported action planning to reduce carried weight(8 weeks after intervention)
- Self-reported weight intended to carry during prospective pregnancies / postpartum(8 weeks after intervention)
- Self-reported outcome expectancies to use safe lifting techniques(8 weeks after intervention)
- Self-reported intention to reduce carried weight(8 weeks after intervention)
- Self-reported action planning to use safe lifting techniques(8 weeks after intervention)
- Self-reported coping planning to use safe lifting techniques(8 weeks after intervention)
- Self-reported self-efficacy to reduce carried weight(8 weeks after intervention)
- Self-reported received social support to use safe lifting techniques(8 weeks after intervention)
- Self-reported risk perception to reduce carried weight(8 weeks after intervention)
- Self-reported perceived barriers to reduce carried weight(8 weeks after intervention)
- Self-reported knowledge on tightening pelvic floor(8 weeks after intervention)
- Observed safe lifting techniques during performance(8 weeks after intervention)
- Self-reported perception and use of pelvic floor muscles during lifting through open questions(8 weeks after intervention)
- Self-reported carrying frequency per week(8 weeks after intervention)
- Self-reported coping planning to reduce carried weight(8 weeks after intervention)
- Self-reported perceived barriers to use safe lifting techniques(8 weeks after intervention)
- Additional self-reported psychosocial determinants to reduce carried weight(8 weeks after intervention)
- Self-reported symptoms of incontinence(8 weeks after intervention)
- Additional self-reported psychosocial determinants of using safe lifting techniques.(8 weeks after intervention)
- Self-reported knowledge on safe carrying behaviors(8 weeks after intervention)
- Self-reported strain during lifting(8 weeks after intervention)
- Self-reported quality of life(8 weeks after intervention)
- Self-reported self-efficacy to use safe lifting techniques(8 weeks after intervention)
- Self-reported received social support to reduce carried weight(8 weeks after intervention)
- Self-reported risk perception to use safe lifting techniques(8 weeks after intervention)
- Self-reported illness-related personal control(8 weeks after intervention)
- Self-reported daily functioning(8 weeks after intervention)
- Self-reported quality of relationships(8 weeks after intervention)