Effect of Hot Footbath on the Sleep Quality

NCT04703530 | Completed

• 1 other identifier: 1-108-05-176
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

Footbath; Quality of sleep; Chronic schizophrenia; Patient

Outcome Measures

Primary Outcomes (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

  pretest

• 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

  up to 4 weeks

Study Arms (2)

Hot footbath effect on schizophrenia patient' sleep quality

EXPERIMENTAL

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

Routine care on schizophrenia patient' sleep quality

NO INTERVENTION

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

hot footbath OTHER

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

Hot footbath effect on schizophrenia patient' sleep quality

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

Tri-Service General Hospital Beitou Branch

Taipei, 112003, Taiwan

Location

Related Publications (6)

• 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.

  PMID: 27061476 RESULT

• 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.

  PMID: 25276739 RESULT

• 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.

  PMID: 10979246 RESULT

• 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.

  PMID: 16155782 RESULT

• 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.

  PMID: 26734475 RESULT

• 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.

  PMID: 20562619 RESULT

Related Links

• Sleep in schizophrenia: A systematic review and meta-analysis of polysomnographic findings in case-control studies. Sleep Medicine Reviews, 32, 69-84.
• Effects of bathing and hot footbath on sleep in winter
• Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control Subjects
• Comparing the effects of reflexology and footbath on sleep quality in the elderly: A controlled clinical trial
• The Effects of Warm-Water Footbath on Relieving Fatigue and Insomnia of the Gynecologic Cancer Patients on Chemotherapy

MeSH Terms

Conditions

Schizophrenia; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Xuan-Yi Huang, DNSc

  National Taipei University of Nursing and Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, DNSc, Professor

Model Details: The research was a randomized controlled trial. 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.

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: January 11, 2021
• Study Start: December 1, 2019
• Primary Completion: January 4, 2020
• Study Completion: July 31, 2020
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)