Weighted Blanket in Pregnancy

NCT ID: NCT07309016

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2027-05-17

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.

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.

Conditions

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

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

This is a self-controlled randomized study.

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.

Group Type: OTHER

Weighted Blanket

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Serap Ejder Apay

Professor of Midwifery and Head of the Department of Midwifery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Serap EJDER APAY, Professor

Role: PRINCIPAL_INVESTIGATOR

Atatürk University Faculty of Health Sciences, Department of Midwifery

Locations

Atatürk University Instiute of Health Sciences, Department of Midwifery

Erzurum, Lütfen Seçiniz., Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

ELİF ERDOĞAN, Mcs

Role: CONTACT

Phone: +905076751643

Email: eliferdogan@atauni.edu.tr

Facility Contacts

ELİF ERDOĞAN, MSc

Role: primary

Serap Ejder Apay, Professor

Role: backup

Other Identifiers

B.30.2.ATA.0.01.00/t

Identifier Type: -

Identifier Source: org_study_id