Leg Cramps, NocturnalWeightedNCT07309016
Weighted Blanket in Pregnancy
A study testing Weighted Blanket in people with Leg Cramps, Nocturnal and Poor Sleep Quality, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Pregnancy is frequently accompanied by sleep disturbances, musculoskeletal discomfort, anxiety, and stress, which may negatively affect maternal well-being and daily functioning. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leg Cramps, Nocturnal, Poor Sleep Quality, Pregnancy
- What is being tested?
- Weighted Blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2025to 17 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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..
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Atatürk University Instiute of Health Sciences, Department of Midwifery
Erzurum, Lütfen Seçiniz., 25010
ELİF ERDOĞAN, MSc, 05076751643 ext. +90, eliferdogan@atauni.edu.tr
Serap Ejder Apay, Professor, serapejder@atauni.edu.tr
About this study
Official title: The Effect of a Weighted Blanket on Lower Leg Cramps, Sleep Quality, Anxiety, and Stress in Pregnant Women: A Randomized Controlled 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.
Read the 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
- Being tested
- Weighted Blanket
- Keywords
- Weighted blanket, sleep, anxiety, stress, cramps, pregnancy
- Medical subject headings
- Sleep-Wake Transition Disorders, Anxiety Disorders, Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted BlanketDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Weighted Blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (after 14-day control phase) Post-intervention (after 14 days of weighted blanket use)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg Cramps, NocturnalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Ejder Apay, Ataturk University
- Investigators
- Serap EJDER APAY, Professor, Principal investigator, Atatürk University Faculty of Health Sciences, Department of Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309016
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/t
- Acronym
- Weighted
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Weighted Blanket on Lower Leg Cramps, Sleep Quality, Anxiety, and Stress in Pregnant Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07309016
- Acronym / sponsor ID
- Weighted / B.30.2.ATA.0.01.00/t
- Conditions
- Leg Cramps, Nocturnal, Poor Sleep Quality, Pregnancy, Anxiety, Stress
- Keywords
- Weighted blanket, sleep, anxiety, stress, cramps, pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 17 May 2027 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| This is a self-controlled randomized study. | Other | Device: Weighted BlanketThis 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted BlanketThe 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. | Device | This is a self-controlled randomized study. |
Primary outcome
Pittsburgh Sleep Quality Index - PSQI
Time frame: Baseline (Day 0-14; control phase) Post-intervention (Day 15-28; after weighted blanket use)
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.
Leg Cramp Questionnaire Form
Time frame: Baseline (Day 0-14; control phase) Post-intervention (Day 15-28)
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.
Perinatal Anxiety Screening Scale (PASS)
Time frame: Baseline (after 14-day control phase) Post-intervention (after 14 days of weighted blanket use)
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.
Pregnancy Stress Rating Scale
Time frame: Baseline (after 14-day control phase) Post-intervention (after 14 days of weighted blanket use)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: 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.
Related trials for Leg Cramps, Nocturnal
Recruiting
The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps
Poor Sleep Quality, Leg Cramps, Nocturnal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Serap EJDER APAY, Professor principal investigator
Atatürk University Faculty of Health Sciences, Department of Midwifery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted Blanket in people with Leg Cramps, Nocturnal and Poor Sleep Quality, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ELİF ERDOĞAN, Mcs (+905076751643, eliferdogan@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index - PSQI (time frame: Baseline (Day 0-14; control phase) Post-intervention (Day 15-28; after weighted blanket use)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.