An interventional study of Weighted Blanket in Leg Cramps, Nocturnal, Poor Sleep Quality and Pregnancy, sponsored by Ataturk University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care
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.
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.
65 studies on the registry are indexed under Muscle Cramp; 9 are open to participants now.
This study's planned enrollment of 50 is close to the median of 50 across 59 interventional studies indexed under Muscle Cramp.
Browse Muscle Cramp studies →Ataturk University is the lead sponsor of 458 studies on the registry; 124 are open to participants now.
Compared within Muscle Cramp, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study is designed to evaluate the effect of weighted blankets on lower leg cramps, sleep quality, anxiety and stress in pregnant women, assessing both the control group and the intervention group. This study is planned as a randomised self-controlled trial. This method was specifically chosen for the study design. The single-group approach allows for comparisons within each individual, significantly reducing the impact of personal differences. This minimises any bias that may arise from inter-individual variability. Furthermore, as multidimensional variables such as the lifestyle habits of pregnant women, their level of physical activity, dietary patterns, and environmental factors affecting sleep patterns have the potential to obscure the results of the study, this method aims to minimise the impact of these factors.
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 compared between the control and intervention periods within the same participants.
Pittsburgh Sleep Quality Index - PSQI
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.
Time frame: Baseline (Day 0-14; control phase) Post-intervention (Day 15-28; after weighted blanket use)
Leg Cramp Questionnaire Form
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.
Time frame: Baseline (Day 0-14; control phase) Post-intervention (Day 15-28)
Perinatal Anxiety Screening Scale (PASS)
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.
Time frame: Baseline (after 14-day control phase) Post-intervention (after 14 days of weighted blanket use)
Pregnancy Stress Rating Scale
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.
Time frame: Baseline (after 14-day control phase) Post-intervention (after 14 days of weighted blanket use)
Plan to share: No — Individual participant data (IPD) will not be shared because the study involves a limited number of participants and data contain potentially identifiable information. Only summarized results will be made available upon reasonable request.
No publications or documents are linked to this record.
Start is estimated for Dec 2025; primary completion for Jul 2026, 6 months later.
Of 20 interventional studies with no phase under Muscle Cramp, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 11. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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