Evidence map›Paper›PMID 39501163›Full record

Trial reportBMC psychiatry2024

Effect of weighted blankets on sleep quality among adults with insomnia: a pilot randomized controlled trial.

Jie Yu, Junan Du, Zhenqing Yang, Weiran Chen, Sudan Sun, Maji Gan, Yuchen Cai, Liming Zhang, Kaili Sun, Jiahui Xu and 5 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC psychiatry, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Jie YuCenter for Clinical Big Data and Analytics of the Second Affiliated Hospital, Department of Big Data in Health Science School of Public Health, Zhejiang Key Laboratory of Intelligent Preventive Medicine, Zhejiang University School of Medicine, Hangzhou, 310058, Zhejiang, China.
Junan DuCenter for Clinical Big Data and Analytics of the Second Affiliated Hospital, Department of Big Data in Health Science School of Public Health, Zhejiang Key Laboratory of Intelligent Preventive Medicine, Zhejiang University School of Medicine, Hangzhou, 310058, Zhejiang, China.
Zhenqing YangCenter for Clinical Big Data and Analytics of the Second Affiliated Hospital, Department of Big Data in Health Science School of Public Health, Zhejiang Key Laboratory of Intelligent Preventive Medicine, Zhejiang University School of Medicine, Hangzhou, 310058, Zhejiang, China.
Weiran ChenCenter for Clinical Big Data and Analytics of the Second Affiliated Hospital, Department of Big Data in Health Science School of Public Health, Zhejiang Key Laboratory of Intelligent Preventive Medicine, Zhejiang University School of Medicine, Hangzhou, 310058, Zhejiang, China.
Sudan SunCenter for Clinical Big Data and Analytics of the Second Affiliated Hospital, Department of Big Data in Health Science School of Public Health, Zhejiang Key Laboratory of Intelligent Preventive Medicine, Zhejiang University School of Medicine, Hangzhou, 310058, Zhejiang, China.
Maji GanCenter for Clinical Big Data and Analytics of the Second Affiliated Hospital, Department of Big Data in Health Science School of Public Health, Zhejiang Key Laboratory of Intelligent Preventive Medicine, Zhejiang University School of Medicine, Hangzhou, 310058, Zhejiang, China.
Yuchen CaiCenter for Clinical Big Data and Analytics of the Second Affiliated Hospital, Department of Big Data in Health Science School of Public Health, Zhejiang Key Laboratory of Intelligent Preventive Medicine, Zhejiang University School of Medicine, Hangzhou, 310058, Zhejiang, China.
Liming ZhangCenter for Clinical Big Data and Analytics of the Second Affiliated Hospital, Department of Big Data in Health Science School of Public Health, Zhejiang Key Laboratory of Intelligent Preventive Medicine, Zhejiang University School of Medicine, Hangzhou, 310058, Zhejiang, China.
Kaili SunCenter for Clinical Big Data and Analytics of the Second Affiliated Hospital, Department of Big Data in Health Science School of Public Health, Zhejiang Key Laboratory of Intelligent Preventive Medicine, Zhejiang University School of Medicine, Hangzhou, 310058, Zhejiang, China.
Jiahui XuDepartment of Neurology/Center for Sleep Medicine, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, 310016, Zhejiang, China.
Qinglin XuDepartment of Neurology/Center for Sleep Medicine, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, 310016, Zhejiang, China.
Juan KeDepartment of Internal Medicine of Traditional Chinese Medicine, Shaoxing Hospital of Traditional Chinese Medicine, Shaoxing, 312000, Zhejiang, China.
Lisan ZhangDepartment of Neurology/Center for Sleep Medicine, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, 310016, Zhejiang, China. zls09@zju.edu.cn.
Yubo ZhuDepartment of Neurology, Affiliated Hospital of Shaoxing University, Shaoxing, 312000, Zhejiang, China. yishanmama131204@163.com.
Zuyun LiuCenter for Clinical Big Data and Analytics of the Second Affiliated Hospital, Department of Big Data in Health Science School of Public Health, Zhejiang Key Laboratory of Intelligent Preventive Medicine, Zhejiang University School of Medicine, Hangzhou, 310058, Zhejiang, China. Zuyun.liu@outlook.com.

Funding

Damian Health Tech (Hangzhou) CO., LTD Kheng-20220141Key Laboratory of Intelligent Preventive Medicine of Zhejiang Province 2020E10004
6 · The paper itself

Abstract

backgroundWeighted blanket is an emerging non-pharmacotherapy for sleep disorders, but its effect on sleep among relatively healthy adults with insomnia remains uncertain. This study aimed to evaluate whether weighted blankets could better improve sleep quality and sleep-related symptoms among adults with insomnia.

methodsIn a prospective, pilot randomized controlled trial conducted in three tertiary hospitals in China, participants with clinical insomnia were randomized (1:1) to receive weighted blanket intervention or normal blanket intervention for 1 month by random-number tables. The primary outcomes were sleep quality assessed with Pittsburgh Sleep Quality Index (PSQI) and insomnia severity assessed with Insomnia Severity Index. Subjective outcomes were measured at baseline, 1 week, and 1-month post-intervention. Sleep was also objectively monitored by actigraphy. We did analysis by intention to treat.

resultsA total of 102 participants were randomly assigned to receive weighted blanket intervention (n = 52) or normal blanket intervention (n = 50). 95 (93.1%) participants completed the follow-up, and 7 (6.9%) participants dropped out of the study. The weighted blanket group had significant improvements in sleep quality compared to the normal blanket group after 1 month of intervention (changes in the mean [SD] of PSQI score: -4.1 [4.1] vs. -2.0 [3.2], P = 0.006). Similar results were observed for daytime sleepiness, stress, anxiety, fatigue, and bodily pain (all P < 0.05). Recordings from actigraphy showed a decrease in the mean (SD) of the number of awakenings in weighted blanket group (-1.4 [9.5]) and an increase in normal blanket group (+ 1.0 [7.9]) (P = 0.280). No severe adverse events occurred.

conclusionsWeighted blanket might be an effective, safe and promising non-pharmacotherapy tool for improving sleep-related symptoms among adults with insomnia, although validation with a larger sample size is needed.

trial registrationChinese Clinical Trial Registry: ChiCTR2300078011, date of registration: 11/27/2023, retrospectively registered.

Indexed as

ActigraphySleep Initiation and Maintenance DisordersSleep QualityAdultChinaFemaleHumansMaleMiddle AgedPilot ProjectsProspective StudiesTreatment OutcomeInsomniaPhysical therapySleepWeighted blanket

Identifiers

PMID39501163
PMCPMC11539645

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.