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CompletedNCT04703530Updated Jan 11, 2021

Effect of Hot Footbath on the Sleep Quality

An interventional study of hot footbath in Schizophrenia, sponsored by National Taipei University of Nursing and Health Sciences. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-01-11.

Sponsored by National Taipei University of Nursing and Health Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Dec 2019, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
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Study summary

The research title is the effect of hot footbath on the sleep quality of patients with chronic schizophrenia. The research was a randomized controlled trial. The setting was the chronic inpatient wards at a psychiatric teaching hospital in Northern Taiwan. A total of 63 participants, 30 in the hot footbath group and 33 in the control group, were completed the study from November 2019 to June 2020. Participants were randomly allocated to the experimental group and the control group. Through this method, we explored whether the trial could effectively improve patients' sleep quality.

Read the detailed description

The research title is the effect of hot footbath on the sleep quality of patients with chronic schizophrenia. The research was a randomized controlled trial. The setting was the chronic inpatient wards at a psychiatric teaching hospital in Northern Taiwan. A total of 63 participants, 30 in the hot footbath group and 33 in the control group, were completed the study from November 2019 to June 2020. Participants were randomly allocated to the experimental group and the control group. The experimental group was given a hot footbath with a temperature of 41℃±1℃ for 20 minutes at about 1-2 hours before sleep, and this was repeated five times a week for four weeks; the control group was given routine care for four weeks. The CPSQI was used to collect the pre- and post-test data. Through this method, we explored whether the trial could effectively improve patients' sleep quality.

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Conditions studied

  • Schizophrenia

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Keywords

  • Footbath
  • Quality of sleep
  • Chronic schizophrenia
  • Patient
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In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's enrollment of 66 is close to the median of 70 across 2,871 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

National Taipei University of Nursing and Health Sciences is the lead sponsor of 119 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Clinical diagnosis of Schizophrenia Disease.
  2. Having Schizophrenia at least two years.
  3. Must have above 5 scores in the Pittsburgh Sleep Quality Index (CPSQI).

Exclusion criteria

Exclusion Criteria:

  1. Having the foot problems, including allergy, wound, swelling, pain, peripheral circulation, and any skeletal, muscular, or nervous lesions in the foot.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Hot footbath effect on schizophrenia patient' sleep quality

    Participants were randomly allocated to the experimental group. The experimental group was given a hot footbath with a temperature of 41℃±1℃ for 20 minutes at about 1-2 hours before sleep, and this was repeated five times a week for four weeks. The CPSQI was used to collect the pre- and post-test data.

    Other: hot footbath

  • No intervention
    Routine care on schizophrenia patient' sleep quality

    Participants were randomly allocated to the control group. They were given routine care for four weeks. The CPSQI was used to collect the pre- and post-test data.

Interventions

  • Otherhot footbath

    The experimental group was given a hot footbath with a temperature of 41℃±1℃ for 20 minutes at about 1-2 hours before sleep

    Also known as: Experimental group

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What researchers measure

Primary outcomes

  1. Pittsburgh Sleep Quality Index

    index scoring from 0 to 3 points, and total 21 points. A total score of all seven indexes \> 5 suggests poor sleep quality

    Time frame: pretest

  2. Pittsburgh Sleep Quality Index

    index scoring from 0 to 3 points, and total 21 points. A total score of all seven indexes \> 5 suggests poor sleep quality

    Time frame: up to 4 weeks

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Study locations

1 site
  • Tri-Service General Hospital Beitou Branch
    Taipei, 112003, Taiwan
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References and documents

Publications

  • Chan MS, Chung KF, Yung KP, Yeung WF. Sleep in schizophrenia: A systematic review and meta-analysis of polysomnographic findings in case-control studies. Sleep Med Rev. 2017 Apr;32:69-84. doi: 10.1016/j.smrv.2016.03.001. Epub 2016 Mar 10. PubMed 27061476 ↗
  • Seyyedrasooli A, Valizadeh L, Zamanzadeh V, Nasiri K, Kalantri H. The effect of footbath on sleep quality of the elderly: a blinded randomized clinical trial. J Caring Sci. 2013 Nov 30;2(4):305-11. doi: 10.5681/jcs.2013.036. eCollection 2013 Dec. PubMed 25276739 ↗
  • Sung EJ, Tochihara Y. Effects of bathing and hot footbath on sleep in winter. J Physiol Anthropol Appl Human Sci. 2000 Jan;19(1):21-7. doi: 10.2114/jpa.19.21. PubMed 10979246 ↗
  • Tsai PS, Wang SY, Wang MY, Su CT, Yang TT, Huang CJ, Fang SC. Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control subjects. Qual Life Res. 2005 Oct;14(8):1943-52. doi: 10.1007/s11136-005-4346-x. PubMed 16155782 ↗
  • Valizadeh L, Seyyedrasooli A, Zamanazadeh V, Nasiri K. Comparing the Effects of Reflexology and Footbath on Sleep Quality in the Elderly: A Controlled Clinical Trial. Iran Red Crescent Med J. 2015 Nov 1;17(11):e20111. doi: 10.5812/ircmj.20111. eCollection 2015 Nov. PubMed 26734475 ↗
  • Yang HL, Chen XP, Lee KC, Fang FF, Chao YF. The effects of warm-water footbath on relieving fatigue and insomnia of the gynecologic cancer patients on chemotherapy. Cancer Nurs. 2010 Nov-Dec;33(6):454-60. doi: 10.1097/NCC.0b013e3181d761c1. PubMed 20562619 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04703530
Lead sponsor
National Taipei University of Nursing and Health Sciences
Responsible party
Xuan-Yi Huang (RN, DNSc, Professor, National Taipei University of Nursing and Health Sciences) — Principal investigator
First posted
Jan 11, 2021
Start date
Dec 1, 2019
Primary completion
Jan 4, 2020
Completion
Jul 31, 2020
Last update
Jan 11, 2021

Study contacts

Xuan-Yi Huang, DNSc
study director · National Taipei University of Nursing and Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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