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Effect of Hot Footbath on the Sleep Quality

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
hot footbath
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Footbath, Quality of sleep, Chronic schizophrenia, Patient

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

  • Tri-Service General Hospital Beitou Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hot footbath effect on schizophrenia patient' sleep quality

Routine care on schizophrenia patient' sleep quality

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
September 25, 2020
Last Updated
January 8, 2021
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04703530
Brief Title
Effect of Hot Footbath on the Sleep Quality
Official Title
Effect of Hot Footbath on the Sleep Quality of Patients With Chronic Schizophrenia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
January 4, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Footbath, Quality of sleep, Chronic schizophrenia, Patient

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hot footbath effect on schizophrenia patient' sleep quality
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine care on schizophrenia patient' sleep quality
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
hot footbath
Other Intervention Name(s)
Experimental group
Intervention Description
The experimental group was given a hot footbath with a temperature of 41℃±1℃ for 20 minutes at about 1-2 hours before sleep
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index
Description
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
Title
Pittsburgh Sleep Quality Index
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Schizophrenia Disease. Having Schizophrenia at least two years. Must have above 5 scores in the Pittsburgh Sleep Quality Index (CPSQI). Exclusion Criteria: 1. Having the foot problems, including allergy, wound, swelling, pain, peripheral circulation, and any skeletal, muscular, or nervous lesions in the foot.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuan-Yi Huang, DNSc
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Tri-Service General Hospital Beitou Branch
City
Taipei
ZIP/Postal Code
112003
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27061476
Citation
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.
Results Reference
result
PubMed Identifier
25276739
Citation
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.
Results Reference
result
PubMed Identifier
10979246
Citation
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.
Results Reference
result
PubMed Identifier
16155782
Citation
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.
Results Reference
result
PubMed Identifier
26734475
Citation
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.
Results Reference
result
PubMed Identifier
20562619
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/27061476/
Description
Sleep in schizophrenia: A systematic review and meta-analysis of polysomnographic findings in case-control studies. Sleep Medicine Reviews, 32, 69-84.
URL
https://doi.org/10.2114/jpa.19.21
Description
Effects of bathing and hot footbath on sleep in winter
URL
https://doi.org/10.1007/s11136-005-4346-x
Description
Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control Subjects
URL
https://doi.org/10.5812/ircmj
Description
Comparing the effects of reflexology and footbath on sleep quality in the elderly: A controlled clinical trial
URL
https://doi.org/10.1097/ncc.0b013e3181d761c1
Description
The Effects of Warm-Water Footbath on Relieving Fatigue and Insomnia of the Gynecologic Cancer Patients on Chemotherapy

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Effect of Hot Footbath on the Sleep Quality

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