A Warm Foot Bath, Sleep Quality and Comfort Level

NCT04413188 | Completed DMC

• 1 other identifier: HanifeB
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Older People; Sleep Problems

Outcome Measures

Primary Outcomes (4)

• 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

  before applying the first foot bath

• 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

  six weeks after the first foot bath

• 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.

  six weeks after the first foot bath

• 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.

  Daily for six weeks

Study Arms (2)

A warm foot bath group

EXPERIMENTAL

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

Other: Warm foot bath

Control group

NO INTERVENTION

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

Interventions

Warm foot bath OTHER

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.

A warm foot bath group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ordu University: lead

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Hanife Durgun, Dr

  Ordu State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized controlled trail

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 2, 2020
• Study Start: December 1, 2016
• Primary Completion: January 31, 2017
• Study Completion: May 31, 2017
• Last Updated: June 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share