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Weighted Blanket in Pregnancy

Sponsored by Ataturk University

About this trial

Last updated 5 months ago

Study ID

B.30.2.ATA.0.01.00/t

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18 to 40 Years
Female

Trial Timing

Started 5 months ago

What is this trial about?

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.

What are the participation requirements?

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