Weighted Blanket in Pregnancy

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.

Hygiene measures include individual duvet covers for each participant, laundering of blankets between uses, and supervised storage of materials. All assessments will be administered by trained research personnel in accordance with standardized procedures.

Statistical analysis will include descriptive statistics, normality assessment, repeated-measures tests, and effect size calculations appropriate for within-subject comparisons. The study aims to determine whether weighted blanket use produces measurable improvements in sleep parameters, musculoskeletal discomfort, and psychological well-being during pregnancy. The results may contribute to evidence-based, complementary care practices in midwifery and prenatal health.

Inclusion criteria

• 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..

Exclusion criteria

• 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