NCT05658783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

November 17, 2022

Last Update Submit

March 6, 2023

Conditions

FootSleepPain

Keywords

FootbathPerioperative nursingPost-operative painSleep quality

Outcome Measures

Primary Outcomes (2)

  • 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.

    In the morning of the surgery day and in the morning of the post-operative day

  • 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.

    In the morning of the surgery day and in the morning of the post-operative day

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Hot water foot bath

Control Group

NO INTERVENTION

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

Interventions

Hot water foot bathOTHER

Keeping keep in 42oC (42 Degrees Celsius) hot water for 20 minutes

Intervention Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Younger than 18 years old
  • Unplanned surgery
  • Have a diagnosed sleep problem and using sleeping pills
  • Having communication problems
  • Not volunteering to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seher Ünver

Edirne, 22030, Turkey (Türkiye)

Location

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainPain, PostoperativeSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Seher Ünver

    Trakya University

    PRINCIPAL INVESTIGATOR

  • Ülkü Çolakoğlu

    Başakşehir Çam & Sakura City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The data analysed by a independent researcher
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 17, 2022

First Posted

December 21, 2022

Study Start

October 5, 2021

Primary Completion

October 10, 2022

Study Completion

November 11, 2022

Last Updated

March 9, 2023

Record last verified: 2023-03

Locations

TU(2)