Weighted Blanket in Pregnancy

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.

NCT Number	NCT07309016
Lead Sponsor	Ataturk University
Conditions	Leg Cramps, Nocturnal, Poor Sleep Quality, Pregnancy, Anxiety, Stress
Enrollment	50 participants
Start Date	2025-12-30
Primary Completion	2026-07-15 (estimated)
Study Completion	2027-05-17 (estimated)
Updated on ClinicalTrials.gov	2025-12-30