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A Warm Foot Bath, Sleep Quality and Comfort Level

Primary Purpose

Older People, Sleep Problems

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Warm foot bath
Sponsored by
T.C. ORDU ÜNİVERSİTESİ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Older People

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 65 years and up
  • relative independent in daily life activities
  • literate
  • having a PSQI score of 5 or more
  • no communication problems.

Exclusion Criteria:

  • who used sleeping drugs or diuretic drugs
  • had peripheral artery diseases
  • neurological diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    A warm foot bath group

    Control group

    Arm Description

    65years, relative independent in daily life activities and literate, having a PSQI score of 5 or more and no communication problems.

    65years, relative independent in daily life activities and literate, having a PSQI score of 5 or more and no communication problems.

    Outcomes

    Primary Outcome Measures

    Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
    The Pittsburgh Sleep Quality Index (PSQI) This index was developed by Buysse and colleagues to evaluate individuals' sleep quality and sleeping disorders over a month. The scale consists of 24 items, 19 of these items are related to self-reporting and are answered by the respondents. This is composed of 19 questions which reflect seven major components. The last five items of the index (11a, 11b, 11c, 11d, and 11e) are answered by the partners or roommates of the participants, and these items are not included in the scoring. Each item is scored with points ranging from 0 to 3, with 0 indicating a "good" score and 3 indicating a "poor" score. Accordingly, higher total scores indicate poor sleep quality; scores of 0-4 indicate good sleep quality, and scores of 5-21 suggest poor sleep quality
    Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
    The Pittsburgh Sleep Quality Index (PSQI) This index was developed by Buysse and colleagues to evaluate individuals' sleep quality and sleeping disorders over a month. The scale consists of 24 items, 19 of these items are related to self-reporting and are answered by the respondents. This is composed of 19 questions which reflect seven major components. The last five items of the index (11a, 11b, 11c, 11d, and 11e) are answered by the partners or roommates of the participants, and these items are not included in the scoring. Each item is scored with points ranging from 0 to 3, with 0 indicating a "good" score and 3 indicating a "poor" score. Accordingly, higher total scores indicate poor sleep quality; scores of 0-4 indicate good sleep quality, and scores of 5-21 suggest poor sleep quality
    Comfort level
    The General Comfort Questionnaire (GCQ) This questionnaire was developed by Katharine Kolcaba in 1992 to determine individuals' comfort needs and evaluate nursing interventions that might be employed to ensure and increase such comfort. The GCQ uses a four-point Likert type scale and consists of 48 items. The lowest score that can be obtained from the scale is 48, the highest score is 192. The total score obtained from the scale was divided by 48 (the number of the items in the scale) to determine the score's mean value which was presented as a score between one and four. The GCQ was adapted for use in a Turkish context by Kuguoğlu and Karabacak in 2004. The Cronbach's alpha coefficient of the original scale was 0.88; in the study by Kuguoglu and Karabacak, it was 0.85. The present study derived a Cronbach's alpha coefficient of 0.68 prior to experimental and 0.75 after experimental.
    Dailiy sleep quality: The Numerical Rating Scale (NRS)
    The Numerical Rating Scale (NRS) This scale was prepared as a form incorporating a scale; it was then used by individuals who were able to mark and assess their personal sleep quality each day. The NRS asks patients to choose the number from 0 to 10 that best represents their sleep with 0 representing a poor night's sleep, and 10 representing a good night's sleep.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 27, 2020
    Last Updated
    June 1, 2020
    Sponsor
    T.C. ORDU ÜNİVERSİTESİ
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04413188
    Brief Title
    A Warm Foot Bath, Sleep Quality and Comfort Level
    Official Title
    Effect of Warm Foot Bath on Their Sleep Quality and Comfort Level in Elderly Individuals: A Randomized-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2016 (Actual)
    Primary Completion Date
    January 31, 2017 (Actual)
    Study Completion Date
    May 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    T.C. ORDU ÜNİVERSİTESİ

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Objectives: To determine the effectiveness of a warm foot bath on sleep quality and comfort level among elderly individuals with sleep problems. Design and methods: This study was a randomized controlled trial. A total of 217 elderly individual who stayed in two nursing homes. The sample consisted of 60 elderly individuals with sleep problem who were randomly assigned to either the warm foot bath group (n= 30) and control group (n=30).The study was completed with 60 elderly individuals. The primary outcome was an information questionnaire, the Pittsburgh Sleep Quality Index, the General Comfort Questionnaire and the Numerical Rating Scale.
    Detailed Description
    The age pyramid of the world population is changing, and as it does so, the percentage of elderly people is rapidly increasing. As one advances in age, it has been found that they tend to sleep latency later, have reduced time spent within crucial rapid eye movement (REM) sleep, and have reduced total duration and quality of sleep and sleep-related problems start to occur. The National Sleep Foundation The national sleep federation recommends 7-8 hours of sleep per day for the elderly. However, many elderly report that they sleep less than recommended and have difficulty sleep latency. Sleeping is a significant action that affects individuals' daily lives as well as their quality of life. Sleep is required to meet the basic needs of daily life and comprises physiological, psychological, environmental and sociocultural dimensions. Sleep quality, which has been considered as increasingly significant in recent years, can be defined as feeling physically-fit, refreshed, and ready for a new day when waking up. Sleep quality consists of several quantitative aspects and measurements of sleep itself, such as the duration before sleep latency, the duration of sleep, the number of times a person wakes up in the night, as well as more subjective aspects such as the depth of sleep and the relaxing characteristic of sleep. Such sleep-related problems may negatively affect an individual's comfort. Comfort is a basic need that comprises one of the cornerstones of holistic nursing care practice. Accordingly, solving sleep-related problems, increasing sleep quality, and ensuring comfort for the individuals concerned will require comprehensive nursing care. Pharmacological methods are the most commonly used approach in trying to resolve sleep-related problems. However, these methods have been insufficient as they do not provide a complete solution for sleep-related problems. Additionally, the side effects of these methods, which are obligatory for the affected individuals, are numerous, and this has paved the way for the development of non-pharmacological treatment methods. Relevant literature indicates methods such as eye masks, music therapy, massages, alternative and supplementary therapies, aromatherapy, and warm foot bath have all been successfully used to solve sleep-related problems among elderly people, thereby boosting their sleep quality and comfort. Warm foot bath causes peripheral vasodilation and decreases core body temperatures. A negative relationship was found between core body temperature and inclination to sleep. Individuals' sleep latency decreases when body core temperature decreases thus, individuals' sleep quality and comfort level are increased. Warm foot bath as a non-pharmacological methods is a more practical and less expensive approach when compared with others. The relevant literature demonstrated that the number of studies examining sleep quality and comfort among elderly people was limited. The literature included some studies that examined the use of relaxation exercises, back-massage practices, aromatherapy, and music therapy to improve sleep quality and comfort. However, the number of studies examining the effect of warm foot bath on sleep quality was found to be limited . The purpose of the trial was to investigate the effect of a warm foot bath on sleep quality and comfort level among elderly individuals with sleep problems. Our primary hypothesis was that the sleep quality of the intervention group would be better after 6 weeks than the control group. The secondary hypotheses were that the comfort levels of the intervention group would be better after 6 weeks than the control group

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Older People, Sleep Problems

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized controlled trail
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A warm foot bath group
    Arm Type
    Experimental
    Arm Description
    65years, relative independent in daily life activities and literate, having a PSQI score of 5 or more and no communication problems.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    65years, relative independent in daily life activities and literate, having a PSQI score of 5 or more and no communication problems.
    Intervention Type
    Other
    Intervention Name(s)
    Warm foot bath
    Intervention Description
    The participants in experimental group were asked to soak their feet in warm water (38-40°C) for 20 minutes one hour before their bedtimes for six weeks. A special foot bath (Beurer FB50 luxury foot bath spa with water heater) was used for this purpose. The bath is 10 cm deep; it keeps water at a constant temperature of 35-48°C for 15-60 minutes, has a display screen for water temperature and duration of use, and turns off automatically.
    Primary Outcome Measure Information:
    Title
    Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
    Description
    The Pittsburgh Sleep Quality Index (PSQI) This index was developed by Buysse and colleagues to evaluate individuals' sleep quality and sleeping disorders over a month. The scale consists of 24 items, 19 of these items are related to self-reporting and are answered by the respondents. This is composed of 19 questions which reflect seven major components. The last five items of the index (11a, 11b, 11c, 11d, and 11e) are answered by the partners or roommates of the participants, and these items are not included in the scoring. Each item is scored with points ranging from 0 to 3, with 0 indicating a "good" score and 3 indicating a "poor" score. Accordingly, higher total scores indicate poor sleep quality; scores of 0-4 indicate good sleep quality, and scores of 5-21 suggest poor sleep quality
    Time Frame
    before applying the first foot bath
    Title
    Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
    Description
    The Pittsburgh Sleep Quality Index (PSQI) This index was developed by Buysse and colleagues to evaluate individuals' sleep quality and sleeping disorders over a month. The scale consists of 24 items, 19 of these items are related to self-reporting and are answered by the respondents. This is composed of 19 questions which reflect seven major components. The last five items of the index (11a, 11b, 11c, 11d, and 11e) are answered by the partners or roommates of the participants, and these items are not included in the scoring. Each item is scored with points ranging from 0 to 3, with 0 indicating a "good" score and 3 indicating a "poor" score. Accordingly, higher total scores indicate poor sleep quality; scores of 0-4 indicate good sleep quality, and scores of 5-21 suggest poor sleep quality
    Time Frame
    six weeks after the first foot bath
    Title
    Comfort level
    Description
    The General Comfort Questionnaire (GCQ) This questionnaire was developed by Katharine Kolcaba in 1992 to determine individuals' comfort needs and evaluate nursing interventions that might be employed to ensure and increase such comfort. The GCQ uses a four-point Likert type scale and consists of 48 items. The lowest score that can be obtained from the scale is 48, the highest score is 192. The total score obtained from the scale was divided by 48 (the number of the items in the scale) to determine the score's mean value which was presented as a score between one and four. The GCQ was adapted for use in a Turkish context by Kuguoğlu and Karabacak in 2004. The Cronbach's alpha coefficient of the original scale was 0.88; in the study by Kuguoglu and Karabacak, it was 0.85. The present study derived a Cronbach's alpha coefficient of 0.68 prior to experimental and 0.75 after experimental.
    Time Frame
    six weeks after the first foot bath
    Title
    Dailiy sleep quality: The Numerical Rating Scale (NRS)
    Description
    The Numerical Rating Scale (NRS) This scale was prepared as a form incorporating a scale; it was then used by individuals who were able to mark and assess their personal sleep quality each day. The NRS asks patients to choose the number from 0 to 10 that best represents their sleep with 0 representing a poor night's sleep, and 10 representing a good night's sleep.
    Time Frame
    Daily for six weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 65 years and up relative independent in daily life activities literate having a PSQI score of 5 or more no communication problems. Exclusion Criteria: who used sleeping drugs or diuretic drugs had peripheral artery diseases neurological diseases.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hanife Durgun, Dr
    Organizational Affiliation
    Ordu State Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    A Warm Foot Bath, Sleep Quality and Comfort Level

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