The Effect of Hot Water After Cesarean Section

NCT ID: NCT05560347

Last Updated: 2022-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2023-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cesarean Section

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, experimental, clinical trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Hot water application

Intervention Type OTHER

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.

Control Group

Routine care will be given to the control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Marmara University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tugba Sivri

Graduate Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0920211278

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Perineal Cryotherapy on Episiotomy
NCT06921200 NOT_YET_RECRUITING NA
Quercetin Effect on Post-ceserean Pain
NCT06650891 COMPLETED PHASE3