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Effect of Footbath on Pain Severity and Sleep Quality

Primary Purpose

Foot, Sleep, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hot water foot bath
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Foot focused on measuring Footbath, Perioperative nursing, Post-operative pain, Sleep quality

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years old and over Undergoing elective surgery Surgery planned for lumbar degenerative disc disease No known sleep problems and no sleeping pills Patients admitted to the ward at least 1 day before the operation Those who will spend the night of the day after the operation in the service Verbal communicative Those who want to take a foot bath in 42oC water Exclusion Criteria: Younger than 18 years old Unplanned surgery Have a diagnosed sleep problem and using sleeping pills Having communication problems Not volunteering to participate

Sites / Locations

  • Seher Ünver
  • Başakşehir Çam and Sakura City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Participants in this study group will be asked to keep their feet in 42oC (42 Degrees Celsius) hot water for 20 minutes on the night of the day of surgery.

Participants in this study group will take the standard service clinical procedure and hot water foot bath will not be applied.

Outcomes

Primary Outcome Measures

Pain severity
will be evaluated with using the Visual Analog Scale (VAS), between "0-no pain" score and "10-unbearable pain" score, is used to evaluate perceived back and/or leg pain severity.
Sleep quality
will be evaluated with using the Visual Analog Sleep Scale (VAS-Scale), numbers ranging from 0 (left side) to 100 (right side), is used to evaluate the previous night's sleep quality of patients. This scale was developed by Verran and Snyder-Halpern and the Turkish validity and reliability of the scale was completed by Çetinkaya and Karabulut. It has one dimension and 10 items.

Secondary Outcome Measures

Full Information

First Posted
November 17, 2022
Last Updated
March 6, 2023
Sponsor
Trakya University
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1. Study Identification

Unique Protocol Identification Number
NCT05658783
Brief Title
Effect of Footbath on Pain Severity and Sleep Quality
Official Title
The Effect of Footbath on Pain Severity and Sleep Quality Levels of Patients With Lumbar Degenerative Disc Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
November 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya University

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
The goal of this clinical trial is to examine the effect of hot water foot bath on the patients' pain severity and sleep quality levels on the night of the lumbar degenerative disc surgery. The main hypotheses are: H1=Pain severity of the patients who applied footbath is lower than the patients who did not. H2=The sleep quality of the patients who applied footbath is higher than the patients who did not. Participants will be asked to keep their feet in 42oC hot water for 20 minutes on the night of the day of surgery. If there is a comparison group: Researchers will compare control group to see if there is any difference on the pain severity and sleep quality of the patients.
Detailed Description
Group allocation of the patients was done through using Random Allocation Software program and patients were allocated into two groups: the intervention group and the control group. Patients in the intervention group were asked to take a footbath in 42oC water for 20-minutes in the evening of the surgery day. The nurse researcher visited the patients in the morning of the surgery day in their service room, asked to rate their current pain severity score between 0 - 10 points, and asked to rate the sleep quality scale items between 0 - 100 points according to their previous night sleep. The patients in the intervention group were informed that they were going to be visited to perform the footbath in the evening before they go asleep, and the patients in the control group were informed that they were going to be visited in the next morning. In the evening of the surgery day, the nurse researcher visited the patients in their service room and explained footbath procedure to the patients, following, filled the foot tub with hot water to approximately 20 cm above the patients' ankle and measured the temperature of the water with using a water thermometer. When the temperature was stable at 42oC, the patients were asked to sit in semi-fowler position in the bed and to immerse their feet in the foot tub without washing or any massage for 20-minutes. During the footbath, the upper side of the foot tub was covered with a towel to prevent temperature loss by vaporizing and the researcher stayed in the room to observe the patient according to any unwanted events such as sweating, having pain, feeling hot or bad etc. At the end of the footbath procedure, feet of the patients were dried with a towel and checked for any redness. Then, the researcher helped patients to wear their socks to keep the feet warm and measured the final temperature of the water. Finally, the patients were informed that they were going to be visited in the morning. The standard procedure is pharmacological pain management following the surgery as explained under the study setting title to decrease the pain severity, consequently, to improve the sleep quality, and this standard procedure was used for each group. Footbath was not applied to the patients in the control group. Patients in both study groups were visited by the nurse researcher in the morning of the postoperative day in their service room, asked to rate their current pain severity score between 0 - 10 points, and asked to rate the sleep quality scale items between 0 - 100 points according to their previous night sleep.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot, Sleep, Pain
Keywords
Footbath, Perioperative nursing, Post-operative pain, Sleep quality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The data analysed by a independent researcher
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants in this study group will be asked to keep their feet in 42oC (42 Degrees Celsius) hot water for 20 minutes on the night of the day of surgery.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in this study group will take the standard service clinical procedure and hot water foot bath will not be applied.
Intervention Type
Other
Intervention Name(s)
Hot water foot bath
Intervention Description
Keeping keep in 42oC (42 Degrees Celsius) hot water for 20 minutes
Primary Outcome Measure Information:
Title
Pain severity
Description
will be evaluated with using the Visual Analog Scale (VAS), between "0-no pain" score and "10-unbearable pain" score, is used to evaluate perceived back and/or leg pain severity.
Time Frame
In the morning of the surgery day and in the morning of the post-operative day
Title
Sleep quality
Description
will be evaluated with using the Visual Analog Sleep Scale (VAS-Scale), numbers ranging from 0 (left side) to 100 (right side), is used to evaluate the previous night's sleep quality of patients. This scale was developed by Verran and Snyder-Halpern and the Turkish validity and reliability of the scale was completed by Çetinkaya and Karabulut. It has one dimension and 10 items.
Time Frame
In the morning of the surgery day and in the morning of the post-operative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old and over Undergoing elective surgery Surgery planned for lumbar degenerative disc disease No known sleep problems and no sleeping pills Patients admitted to the ward at least 1 day before the operation Those who will spend the night of the day after the operation in the service Verbal communicative Those who want to take a foot bath in 42oC water Exclusion Criteria: Younger than 18 years old Unplanned surgery Have a diagnosed sleep problem and using sleeping pills Having communication problems Not volunteering to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seher Ünver
Organizational Affiliation
Trakya University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ülkü Çolakoğlu
Organizational Affiliation
Basaksehir Cam & Sakura Şehir Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seher Ünver
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Başakşehir Çam and Sakura City Hospital
City
İstanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effect of Footbath on Pain Severity and Sleep Quality

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