Cesarean SectionNCT05560347
The Effect of Hot Water After Cesarean Section
A study testing Hot water application in people with Cesarean Section, run by Marmara University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Hot water application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2022to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cesarean Section
- Being tested
- Hot water application
- Keywords
- Cesarean section, Hot Water, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot water applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Hot water application |
| Control Group | No intervention | Routine care will be given to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3rd and 6th hours after cesarean section
Secondary outcomes (1)
Change the comfort score
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.
Measured: 12 th hours after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start15 Oct 2022 (estimated)
- Primary completion15 Mar 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, experimental, clinical trial
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Sivri, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560347
- Sponsor's protocol ID
- 0920211278
- Status last verified
- Sep 2022
- First submitted
- 20 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hot Water Application on Pain, Comfort and Vital Singns After Cesarean
- ClinicalTrials.gov ID
- NCT05560347
- Acronym / sponsor ID
- 0920211278
- Conditions
- Cesarean Section
- Keywords
- Cesarean section, Hot Water, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (estimated)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, experimental, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Hot water applicationHot 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. |
| Control Group | No intervention | –Routine care will be given to the control group |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Not a primary school graduate
- Under 18 years old
- Blood pressure, diabetes, etc. sick
- Diagnosed with risky pregnancy,
- Complications developing during or after surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hot water applicationHot 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. | Other | Experimental Group |
Primary outcome
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.
1 secondary outcome
Change the comfort score
Time frame: 12 th hours after cesarean section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hot water application in people with Cesarean Section, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain assessed by VAS score (time frame: 3rd and 6th hours after cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.