Weighted Blanket in Pregnancy

Official title

The Effect of a Weighted Blanket on Lower Leg Cramps, Sleep Quality, Anxiety, and Stress in Pregnant Women: A Randomized Controlled Trial

Overview

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.

Detailed description

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.

Interventions

• Device Weighted Blanket
  The intervention involves the use of a weighted blanket designed to provide deep pressure stimulation during sleep. Each participant will first complete a 2-week control period with routine sleep conditions, during which baseline data will be collected. Immediately following this phase, participants will use the weighted blanket nightly for 2 weeks. No wash-out period will be applied between phases. Outcomes such as lower leg cramps, sleep quality, anxiety, and stress levels will be assessed and

Primary outcome measures

• Pittsburgh Sleep Quality Index - PSQI [Time frame: Baseline (Day 0-14; control phase) Post-intervention (Day 15-28; after weighted blanket use)]
• Leg Cramp Questionnaire Form [Time frame: Baseline (Day 0-14; control phase) Post-intervention (Day 15-28)]
• Perinatal Anxiety Screening Scale (PASS) [Time frame: Baseline (after 14-day control phase) Post-intervention (after 14 days of weighted blanket use)]
• Pregnancy Stress Rating Scale [Time frame: Baseline (after 14-day control phase) Post-intervention (after 14 days of weighted blanket use)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Atatürk University Instiute of Health Sciences, Department of Midwifery — Erzurum

Identifiers

NCT: NCT07309016 · B.30.2.ATA.0.01.00/t

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗