Effect of Hot Footbath on the Sleep Quality

NCT ID: NCT04703530

Last Updated: 2021-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

hot footbath

Intervention Type 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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Experimental group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xuan-Yi Huang

RN, DNSc, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xuan-Yi Huang, DNSc

Role: STUDY_DIRECTOR

National Taipei University of Nursing and Health Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tri-Service General Hospital Beitou Branch

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 27061476 (View on PubMed)

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.

Reference Type RESULT
PMID: 25276739 (View on PubMed)

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.

Reference Type RESULT
PMID: 10979246 (View on PubMed)

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.

Reference Type RESULT
PMID: 16155782 (View on PubMed)

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.

Reference Type RESULT
PMID: 26734475 (View on PubMed)

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.

Reference Type RESULT
PMID: 20562619 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://pubmed.ncbi.nlm.nih.gov/27061476/

Sleep in schizophrenia: A systematic review and meta-analysis of polysomnographic findings in case-control studies. Sleep Medicine Reviews, 32, 69-84.

https://doi.org/10.2114/jpa.19.21

Effects of bathing and hot footbath on sleep in winter

https://doi.org/10.1007/s11136-005-4346-x

Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control Subjects

https://doi.org/10.5812/ircmj

Comparing the effects of reflexology and footbath on sleep quality in the elderly: A controlled clinical trial

https://doi.org/10.1097/ncc.0b013e3181d761c1

The Effects of Warm-Water Footbath on Relieving Fatigue and Insomnia of the Gynecologic Cancer Patients on Chemotherapy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1-108-05-176

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.