Weighted Blanket in Pregnancy

NCT07309016 | Not Yet Recruiting DMC

• 1 other identifier: B.30.2.ATA.0.01.00/t
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leg Cramps, Nocturnal; Poor Sleep Quality; Pregnancy; Anxiety; Stress

Keywords

Weighted blanket; sleep; anxiety; stress; cramps; pregnancy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline (after 14-day control phase) Post-intervention (after 14 days of weighted blanket use)

Study Arms (1)

This is a self-controlled randomized study.

OTHER

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

Interventions

Weighted Blanket DEVICE

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.

This is a self-controlled randomized study.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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..

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk University Instiute of Health Sciences, Department of Midwifery

Erzurum, Lütfen Seçiniz., 25010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep-Wake Transition Disorders; Anxiety Disorders; Muscle Cramp

Condition Hierarchy (Ancestors)

Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Serap EJDER APAY, Professor

  Atatürk University Faculty of Health Sciences, Department of Midwifery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ELİF ERDOĞAN, Mcs

CONTACT

+905076751643; eliferdogan@atauni.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Midwifery and Head of the Department of Midwifery

Model Details: The study will be conducted using a single-group self-controlled design. Participants will first receive standard prenatal care without intervention for two weeks, followed by the weighted blanket intervention for two weeks. This approach allows comparison within the same individual, minimizing variability caused by personal differences or environmental factors.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 30, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): May 17, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)