SchizophreniaNCT04703530
Effect of Hot Footbath on the Sleep Quality
A study testing hot footbath in people with Schizophrenia, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- hot footbath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Schizophrenia Disease.
- Having Schizophrenia at least two years.
- Must have above 5 scores in the Pittsburgh Sleep Quality Index (CPSQI).
Who cannot join
- 1. Having the foot problems, including allergy, wound, swelling, pain, peripheral circulation, and any skeletal, muscular, or nervous lesions in the foot.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Hot Footbath on the Sleep Quality of Patients With Chronic Schizophrenia: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- hot footbath
- Keywords
- Footbath, Quality of sleep, Chronic schizophrenia, Patient
- Medical subject headings
- Schizophrenia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hot footbathOther
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start1 Dec 2019
- Primary completion4 Jan 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuan-Yi Huang, National Taipei University of Nursing and Health Sciences
- Investigators
- Xuan-Yi Huang, DNSc, Study director, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703530
- Sponsor's protocol ID
- 1-108-05-176
- Status last verified
- Jan 2021
- First submitted
- 25 Sep 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27061476Seyyedrasooli 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.
PubMed 25276739Sung 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.
PubMed 10979246Tsai 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.
PubMed 16155782Valizadeh 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.
PubMed 26734475Yang 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.
PubMed 20562619
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hot Footbath on the Sleep Quality of Patients With Chronic Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04703530
- Acronym / sponsor ID
- 1-108-05-176
- Conditions
- Schizophrenia
- Keywords
- Footbath, Quality of sleep, Chronic schizophrenia, Patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 4 Jan 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hot footbath effect on schizophrenia patient' sleep quality | Experimental | Other: hot footbathParticipants 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. |
| 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Schizophrenia Disease.
- Having Schizophrenia at least two years.
- Must have above 5 scores in the Pittsburgh Sleep Quality Index (CPSQI).
Key exclusion criteria (1 listed)
- 1. Having the foot problems, including allergy, wound, swelling, pain, peripheral circulation, and any skeletal, muscular, or nervous lesions in the foot.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hot footbathAlso: Experimental groupThe experimental group was given a hot footbath with a temperature of 41℃±1℃ for 20 minutes at about 1-2 hours before sleep | Other | Hot footbath effect on schizophrenia patient' sleep quality |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: pretest
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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Results publication: PubMed 27061476Chan 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 publication: PubMed 25276739Seyyedrasooli 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 publication: PubMed 10979246Sung 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 publication: PubMed 16155782Tsai 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 publication: PubMed 26734475Valizadeh 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 publication: PubMed 20562619Yang 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.
- Sleep in schizophrenia: A systematic review and meta-analysis of polysomnographic findings in case-control studies. Sleep Medicine Reviews, 32, 69-84.Link provided by the sponsor.
- Effects of bathing and hot footbath on sleep in winterLink provided by the sponsor.
- Psychometric evaluation of the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI) in primary insomnia and control SubjectsLink provided by the sponsor.
- Comparing the effects of reflexology and footbath on sleep quality in the elderly: A controlled clinical trialLink provided by the sponsor.
- The Effects of Warm-Water Footbath on Relieving Fatigue and Insomnia of the Gynecologic Cancer Patients on ChemotherapyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuan-Yi Huang, DNSc study director
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hot footbath in people with Schizophrenia, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (time frame: pretest). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04703530, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.