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Effect of Hot Footbath on the Sleep Quality

Sponsor
National Taipei University of Nursing and Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT04703530
Collaborator
(none)
66
Enrollment
1
Location
2
Arms
8
Actual Duration (Months)
8.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: hot footbath
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Effect of Hot Footbath on the Sleep Quality of Patients With Chronic Schizophrenia: A Randomized Controlled Trial
Actual Study Start Date :
Dec 1, 2019
Actual Primary Completion Date :
Jan 4, 2020
Actual Study Completion Date :
Jul 31, 2020

Arms and Interventions

Arm Intervention/Treatment
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
The experimental group was given a hot footbath with a temperature of 41℃±1℃ for 20 minutes at about 1-2 hours before sleep
Other Names:
  • Experimental group

    		•
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Pittsburgh Sleep Quality Index [pretest]

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

    2. Pittsburgh Sleep Quality Index [up to 4 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    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:
    1. Having the foot problems, including allergy, wound, swelling, pain, peripheral circulation, and any skeletal, muscular, or nervous lesions in the foot.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tri-Service General Hospital Beitou Branch Taipei Taiwan 112003

    Sponsors and Collaborators

    • National Taipei University of Nursing and Health Sciences

    Investigators

    • Study Director: Xuan-Yi Huang, DNSc, National Taipei University of Nursing and Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Xuan-Yi Huang, RN, DNSc, Professor, National Taipei University of Nursing and Health Sciences
    ClinicalTrials.gov Identifier:
    NCT04703530
    Other Study ID Numbers:
    • 1-108-05-176
    First Posted:
    Jan 11, 2021
    Last Update Posted:
    Jan 11, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xuan-Yi Huang, RN, DNSc, Professor, National Taipei University of Nursing and Health Sciences
    Footbath
    Quality of sleep
    Chronic schizophrenia
    Patient
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of Jan 11, 2021