The Effect of Hot Water After Cesarean Section

September 28, 2022 updated by: Tugba Sivri, Marmara University

The Effect of Hot Water Application on Pain, Comfort and Vital Singns After Cesarean

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cesarean section surgery is an attempt to become mandatory and applied in cases where vaginal delivery is dangerous for the mother and fetus. One of the most common problems that women experience in the process after cesarean section is pain. This pain experienced for various reasons such as incision site pain, headache and pain caused by uterine contractions negatively affects the comfort of the woman in the postpartum period. In addition to pain, especially after cesarean section, the woman cannot be mobilized, the presence of a urinary catheter, the negative effects caused by anesthesia cause the mother to be unable to meet her own self-care needs and perform life activities, which disrupts the comfort of the woman As a result of the study in which Çankaya evaluated the comfort of mothers who gave birth by cesarean section, it was found that 78% of mothers have pain at the incision site and this negatively affects maternal comfort The pain that cannot be controlled causes a limitation in activities, respiratory, circulatory and digestive system problems in the postoperative period and prolongs the recovery period. Therefore, the woman's pain should be managed and aimed at minimizing it. In this context, when looking at the literature, it is noticeable that there are various methods of dealing with pain after cesarean section. Pharmacological treatment options are preferred in the management of pain after cesarean section due to their ability to reduce and treat pain in a shorter period of time. After cesarean section, more often non-steroidal anti-inflammatory drugs or paracetamol-derived drugs are used. Non-pharmacological methods should also be used in pain management to support pharmacological methods and minimize the use of analgesics Some non-pharmacological methods used can be listed as follows; aromatherapy, massage hand/foot massage, listening to music, progressive relaxation exercises, acupuncture, hot and cold applications. A limited number of studies on hot application have been found in the literature. Based on these results, this study is planned to examine the effects of hot water application on pain comfort and life signs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • At least primary school graduate
  • 18 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental Group
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
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.
NO_INTERVENTION: Control Group
Routine care will be given to the control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pain assessed by VAS score
Time Frame: 3rd and 6th hours after cesarean section
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change the comfort score
Time Frame: 12 th hours after cesarean section
Chancing the comfort score after cesarean section. The data will be obtained by using the Postpartum Comfort Scale. Postpartum Comfort Scale (PCS): It is a Likert-type scale consisting of 34 items to determine the postpartum comfort. The lowest and the highest scores in the scale are 34 and 170. It has three sub dimensions; physical, psycho spiritual and sociocultural. Scores close to 170 indicate ahigh level of comfort.
12 th hours after cesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0920211278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings