Effect of Hot Footbath on the Sleep Quality

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Hot Footbath on the Sleep Quality of Patients With Chronic Schizophrenia: A Randomized Controlled Trial

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: hot footbath


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hot footbath effect on schizophrenia patient' sleep quality<br>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<br>* The experimental group was given a hot footbath with a temperature of 41℃±1℃ for 20 minutes at about 1-2 hours before sleep<br>* Other names: Experimental group;|
| No Intervention: Routine care on schizophrenia patient' sleep quality<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Footbath, Quality of sleep, Chronic schizophrenia, Patient