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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05560347
Other study ID # 0920211278
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 15, 2022
Est. completion date June 15, 2023

Study information

Verified date September 2022
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date June 15, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 12 th hours after cesarean section
See also
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Active, not recruiting NCT04965779 - The Effect of Abdominal Binder Use on Postpartum Pain, Bleeding, and Breastfeeding Success in Cesarean Delivery Women N/A
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Terminated NCT05051150 - Epinephrine Infusion for Prophylaxis Against Maternal Hypotension During Caesarean Section Phase 4
Terminated NCT03695172 - Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section Phase 4
Recruiting NCT06247852 - Persistent Pain After Cesarean Delivery - A Danish Multicenter Cohort Study
Completed NCT06012747 - Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Not yet recruiting NCT05187520 - Naldebain for Control of Post-Cesarean Section Pain Phase 2
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A