Clinical trial NCT04703530: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Footbath
Quality of sleep
Chronic schizophrenia
Patient
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: pretest
measure: Pittsburgh Sleep Quality Index
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital Beitou Branch
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Xuan-Yi Huang, DNSc
role: STUDY_DIRECTOR
References:
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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.
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.
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.
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.
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.