NCT05609838

Brief Summary

The aim of this research is to determine the effect of hot water foot bath applied in the early period after cesarean section on pain, fatigue and gas release.The sample of the research consisted of 80 women who gave birth by cesarean section. 'Descriptive Information Form', 'Numerical Rating Scale', 'Visual Analogue Scale for Fatigue', 'Experimental Group Patient Follow-up Form', 'Control Group Patient Follow-up Form' were used as data collection tools. It was determined that the hot water foot bath applied in the early period after cesarean section reduced the level of pain and fatigue, and had no effect on gas release.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

December 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

November 1, 2022

Last Update Submit

November 7, 2022

Conditions

Keywords

Nursingcesarean sectionpainfatigue

Outcome Measures

Primary Outcomes (4)

  • The numerical rating scale (NRS)

    It is a frequently preferred scale because it is thought to be easy to apply. With this scale, the patient's pain is explained with numerical values. Pain severity assessment in numerical scales is applied as a rating starting with "0" and up to "10" level. Here, "0" means no pain, "10" means unbearable pain. In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers.

    at the 3rd hour after cesarean section before hot water foot bath application

  • The numerical rating scale (NRS)

    It is a frequently preferred scale because it is thought to be easy to apply. With this scale, the patient's pain is explained with numerical values. Pain severity assessment in numerical scales is applied as a rating starting with "0" and up to "10" level. Here, "0" means no pain, "10" means unbearable pain. In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers.

    at the 5th minute after the application of hot water foot bath

  • The numerical rating scale (NRS)

    It is a frequently preferred scale because it is thought to be easy to apply. With this scale, the patient's pain is explained with numerical values. Pain severity assessment in numerical scales is applied as a rating starting with "0" and up to "10" level. Here, "0" means no pain, "10" means unbearable pain. In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers.

    at the 1st hour after the application of hot water foot bath

  • The numerical rating scale (NRS)

    It is a frequently preferred scale because it is thought to be easy to apply. With this scale, the patient's pain is explained with numerical values. Pain severity assessment in numerical scales is applied as a rating starting with "0" and up to "10" level. Here, "0" means no pain, "10" means unbearable pain. In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers.

    at the 2nd hour after the application of hot water foot bath

Secondary Outcomes (4)

  • 'Visual Analogue Scale for Fatigue (VAS-F)

    at the 3rd hour after cesarean section before hot water foot bath application

  • 'Visual Analogue Scale for Fatigue (VAS-F)

    at the 5th minute after the application of hot water foot bath

  • 'Visual Analogue Scale for Fatigue (VAS-F)

    at the 1st hour after the application of hot water foot bath

  • 'Visual Analogue Scale for Fatigue (VAS-F)

    at the 2nd hour after the application of hot water foot bath

Study Arms (2)

Experimental group

EXPERIMENTAL

A 15 minutes hot water foot bath was applied to the experimental group patients 3 hours after the cesarean section.Data collection tools were applied at the 5th minute, 1st hour and 2nd hour after the hot water footbath and the gas output was questioned.

Other: Hot water foot bath

Control Group

NO INTERVENTION

The control group was given routine post-cesarean care without any intervention and data collection tools were applied at the same time as the experimental group.

Interventions

A 15 minutes hot water foot bath was applied to the experimental group patients 3 hours after the cesarean section.

Experimental group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • T.C. citizen of
  • over 18 years old
  • No history of any medical illness
  • Receiving spinal anesthesia in cesarean section
  • No complications during or after cesarean section
  • Those who have not had any problems during pregnancy
  • No mental handicap or perception problems and no communication difficulties
  • Women who do not release gas before applying a hot water foot bath

You may not qualify if:

  • Those who have intestinal discomfort during pregnancy and before pregnancy, have undergone intestinal surgery
  • Gas-releasing before hot water footbath application
  • sensory loss
  • Wounds and/or lesions on their feet
  • Those with vascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, 27000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainFatigue

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Oya KAPLAN, PhD Student

    University of Gaziantep

    PRINCIPAL INVESTIGATOR
  • Simge ZEYNELOĞLU, Professor

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The researcher knew which of the participants belonged to the experimental and control groups, but the participants did not know. It is a single-blind study.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two groups (experimental group and control group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 8, 2022

Study Start

December 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations