Weighted Blanket in Pregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorAtaturk University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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,
Disqualifiers
Those who have been diagnosed with high-risk pregnancy,
Preeclampsia or eclampsia, placenta previa,
Gestational diabetes requiring insulin,
Diagnosis of fetal growth retardation,
Trial design
Design model
Single group
Treatments tested in this trial
Weighted Blanket
DeviceThe 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: This is a self-controlled randomized study.Other 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov
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