The Effect of a Weighted Blanket on Lower Leg Cramps, Sleep Quality, Anxiety, and Stress in Pregnant Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index - PSQI
研究概览
简要总结
Pregnancy is frequently accompanied by sleep disturbances, musculoskeletal discomfort, anxiety, and stress, which may negatively affect maternal well-being and daily functioning. Weighted blankets, which provide deep pressure stimulation, have been used as a non-pharmacological method to promote relaxation, improve sleep quality, and reduce stress and anxiety. However, their effects have not been evaluated in pregnant women. This study aims to examine the effect of weighted blanket use on lower leg cramps, sleep quality, anxiety, and stress levels among pregnant women. The trial uses a randomized, self-controlled design in which each participant completes a 14-day control period without the blanket and a subsequent 14-day intervention period using the weighted blanket. Data will be collected using validated measurement tools. The findings are expected to provide evidence for a safe, non-pharmacological supportive approach that may enhance comfort and psychological well-being during pregnancy.
详细描述
Pregnancy involves physiological and psychological changes that may contribute to sleep difficulties, lower extremity cramping, and increased levels of anxiety and stress. Because pharmacological approaches are often limited during pregnancy, non-pharmacological strategies are important for promoting maternal comfort and well-being. Weighted blankets provide evenly distributed pressure across the body, generating deep pressure stimulation that may induce relaxation, reduce arousal, and support more stable sleep patterns.
This study is designed as a randomized, self-controlled trial to evaluate the effects of weighted blanket use on sleep quality, lower leg cramps, anxiety, and stress in pregnant women. The study includes one group of participants who undergo two consecutive phases:
Control Phase (14 days): Participants complete daily sleep diaries and standardized assessments without using a weighted blanket.
Intervention Phase (14 days): Participants receive an 8-kg glass-bead weighted blanket and use it during the sleep initiation period (approximately 40 minutes each night). Daily sleep diaries and standardized assessments are repeated following the intervention.
To support participant safety, the blanket weight will not exceed 8-10% of body weight, and participants will be instructed to use the blanket only during sleep onset. Participants will receive guidance on maintaining a safe sleep posture, particularly the left lateral position. Weekly follow-up phone calls will be conducted to monitor adherence, comfort, and potential adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primarily pregnant women between the ages of 18 and 40 ,
- •Low BMI (to be able to use 8kg weighted blanket),
- •Gestational week ≥ 28,
- •Third trimester pregnant women,
- •Singleton pregnancy,
- •Ability to communicate verbally and in writing in Turkish,
- •Willingness to participate in research and comply with intervention protocols..
排除标准
- •Those who have been diagnosed with high-risk pregnancy,
- •Preeclampsia or eclampsia, placenta previa,
- •Gestational diabetes requiring insulin,
- •Diagnosis of fetal growth retardation,
- •Polyhydramnios or oligohydramnios, asthma , sleep apnea or serious heart/circulatory problems,
- •History of bleeding during pregnancy,
- •Obstetric complications requiring close medical monitoring.
- •Multiple pregnancies,
- •Previously diagnosed with a sleep disorder,
- •Having been diagnosed with a psychiatric disorder
- •Multiparous pregnant women,
- •Pregnant women in the first two trimesters ,
- •Night shift workers
结局指标
主要结局
Pittsburgh Sleep Quality Index - PSQI
时间窗: Baseline (Day 0-14; control phase) Post-intervention (Day 15-28; after weighted blanket use)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, a validated 19-item instrument that generates a total score based on seven components of sleep. Total PSQI scores range from 0 to 21, with higher scores indicating poorer sleep quality. The change in PSQI total score from baseline (control period) to post-intervention will be evaluated.
Leg Cramp Questionnaire Form
时间窗: Baseline (Day 0-14; control phase) Post-intervention (Day 15-28)
Lower leg cramps will be evaluated using participant-reported frequency (number of cramps per week) and severity (rated on a 0-10 Numeric Rating Scale, where 0 = no pain and 10 = most severe pain). Changes between the 14-day control phase and the 14-day intervention phase will be assessed.
Perinatal Anxiety Screening Scale (PASS)
时间窗: Baseline (after 14-day control phase) Post-intervention (after 14 days of weighted blanket use)
Anxiety levels will be assessed using the Perinatal Anxiety Screening Scale, a validated 31-item instrument. The total PASS score ranges from 0 to 93, with higher scores indicating greater perinatal anxiety. Total scores will be compared before and after the intervention.
Pregnancy Stress Rating Scale
时间窗: Baseline (after 14-day control phase) Post-intervention (after 14 days of weighted blanket use)
Pregnancy-related stress will be measured using the Pregnancy Stress Rating Scale, a validated 36-item scale. Total scores range from 0 to 144, with higher scores reflecting higher levels of pregnancy-related stress. The change in PSRS total score from baseline to post-intervention will be evaluated.
次要结局
未报告次要终点
研究者
Serap Ejder Apay
Professor of Midwifery and Head of the Department of Midwifery
Ataturk University