NCT05560347

Brief Summary

The main subject of this project is the problem of pain after cesarean section. It is known that the application of hot water reduces the pain of the patients, with the decrease of the pain, the vital signs of the patient are improved and the comfort level increases. Our project work is based on this subject.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

September 20, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

October 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

September 20, 2022

Last Update Submit

September 28, 2022

Conditions

Keywords

Cesarean sectionHot WaterPain

Outcome Measures

Primary Outcomes (1)

  • Change in Pain assessed by VAS score

    Chancing in pain after cesarean section. The data will be obtained by using Visual Analog Scale. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain.

    3rd and 6th hours after cesarean section

Secondary Outcomes (1)

  • Change the comfort score

    12 th hours after cesarean section

Study Arms (2)

Experimental Group

EXPERIMENTAL

Hot water will be applied to the participants in the experimental group at the 2nd and 6th hours postoperatively. During the hot water application, the feet of the individual will be immersed in the hot water application device and kept in the device for 20 minutes. At the end of the 20th minute, the feet of the individual will be removed from the device and dried with a towel for 10 minutes and the application will be completed. The data will be obtained by using the Introductory Information Form, Visual Analog Scale (VAS), Postpartum Comfort Scale and Post Cesarean Patient Evaluation Form.

Other: Hot water application

Control Group

NO INTERVENTION

Routine care will be given to the control group

Interventions

Hot application is applied by contacting any part of the body with a temperature of 40-45 degrees. Hot application stimulates the touch receptors and has a vasodilation effect. Thermoreceptors in the foot are stimulated by applying heat to the feet, and this stimulation is thought to be effective in reducing the activation of the sympathetic nervous system and thus reducing pain.

Experimental Group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • At least primary school graduate
  • years and older
  • No history of chronic disease (Diabetes, etc.)
  • Risky pregnancy (Premature rupture of membranes, Premature birth threat, preeclampsia etc.) without diagnosis
  • Women who do not develop any complications (Atony, abnormal bleeding, need for blood transfusion, risks related to anesthesia, bladder injury, etc.) during or after the operation.

You may not qualify if:

  • Not a primary school graduate
  • Under 18 years old
  • Blood pressure, diabetes, etc. sick
  • Diagnosed with risky pregnancy,
  • Complications developing during or after surgery
  • Women who do not want to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized, controlled, experimental, clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 29, 2022

Study Start

October 15, 2022

Primary Completion

March 15, 2023

Study Completion

June 15, 2023

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share