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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05312515
Other study ID # 0000-0002-7453-1205
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date December 30, 2022

Study information

Verified date May 2023
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The postpartum period is a process in which both physical (bleeding, infection, anemia) and emotional (delay in breastfeeding and mother-baby relationship) problems occur in women. Among the conditions that physically affect the woman who has had a cesarean section, a decrease in bowel movements is often seen and this decrease can last for 24 hours or longer. Initiation of bowel movements after surgery, time of first flatulence and defecation are important factors that determine postoperative patient comfort.


Description:

Pain after cesarean section is usually associated with incision site and uterine contractions. There are various medical treatment and midwifery applications for the resolution of pain and gas output after cesarean section. Recently, it has been stated that in addition to the treatments applied after surgery, non-drug methods should be used to increase the effectiveness of recovery. These methods include applications such as hot application, abdominal massage, music therapy, chewing gum. The effect of hot application in patients with post-operative gas problems is the acupuncture points of the foot, warm and moist heat stimulation and the small intestine, colon, anus and other reflective areas. activates blood circulation. It is predicted that postpartum comfort will increase in the postpartum postpartum, whose pain decreases with postpartum heat application and intestinal mobility returns to normal. The aim of this study is to determine the effect of applying heat to the feet after cesarean section on postpartum comfort, pain and gas output.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date December 30, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - over 18 years old - Can read and understand Turkish - No history of any medical illness - Singular pregnancy - No complications during or after surgery - Those who have not had any problems during pregnancy - giving birth to a live baby - No diagnosed psychological disorder - Women who do not pass gas before applying heat Exclusion Criteria: - From gas before hot application - Hearing loss - The baby is in intensive care - Women with vascular diseases - Women who were taken to the intensive care unit after surgery due to any complications

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Warm Application to Feet
Warm Application to Feet after Cesarean Section

Locations

Country Name City State
Turkey Dr. Ali Kemal Belviranli Gynecology and Pediatrics Hospital Konya

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Büyükkayaci Duman N, Karatas N. Sezaryen Sonrasi Erken Taburcu Olan Kadinlara Verilen Evde Bakim Hizmetinin Anne Sagligina Ve Öz Bakim Gücüne Etkisi. Saglik Bil Derg 2011, 20(1):54-67.

Ciardulli A, Saccone G, Di Mascio D, Caissutti C, Berghella V. Chewing gum improves postoperative recovery of gastrointestinal function after cesarean delivery: a systematic review and meta-analysis of randomized trials. J Matern Fetal Neonatal Med. 2018 Jul;31(14):1924-1932. doi: 10.1080/14767058.2017.1330883. Epub 2017 Jun 6. — View Citation

Sell SE, Beresford PC, Dias HHZR, Garcia ORZ, Santos EKA. Looks and knowledge: experiences of mothers and nursing staff regarding post-caesarean section pain. Text Context Nurs., 2012, 21(4): 766-74.

Sutton CD, Carvalho B. Optimal Pain Management After Cesarean Delivery. Anesthesiol Clin. 2017 Mar;35(1):107-124. doi: 10.1016/j.anclin.2016.09.010. Epub 2016 Dec 12. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Introductory Information Form It was prepared by the researcher to describe the sociodemographic characteristics and current health status of women. The group of women will be marked as Intervention or Control. at the beginning of the study
Primary Post Cesarean Section Follow-up Form-First follow up In this form, the time the patient was taken into surgery; length of stay in the recovery unit; time of service; the type of anesthesia administered; It was created by the researcher in order to obtain information about the hot water bag application time and the first gas removal time. application after 30 minute
Primary Post Cesarean Section Follow-up Form-Second follow up In this form, the time the patient was taken into surgery; length of stay in the recovery unit; time of service; the type of anesthesia administered; It was created by the researcher in order to obtain information about the hot water bag application time and the first gas removal time. application after 60 minute
Primary Post Cesarean Section Follow-up Form-Third follow up In this form, the time the patient was taken into surgery; length of stay in the recovery unit; time of service; the type of anesthesia administered; It was created by the researcher in order to obtain information about the hot water bag application time and the first gas removal time. application after 120 minute
Secondary Visual Pain Scale (VAS)-First follow up It is a measurement usually used to evaluate pain from 0 (no pain) to 10 (unbearable pain). In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers. The number expressed by the patient is accepted as the intensity of pain felt at that moment. application after 30 minute
Secondary Visual Pain Scale (VAS)-Second follow up It is a measurement usually used to evaluate pain from 0 (no pain) to 10 (unbearable pain). In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers. The number expressed by the patient is accepted as the intensity of pain felt at that moment. application after 60 minute
Secondary Visual Pain Scale (VAS)-Third follow up It is a measurement usually used to evaluate pain from 0 (no pain) to 10 (unbearable pain). In this assessment scale, the patient is asked to express the level of pain he/she feels at that moment with numbers. The number expressed by the patient is accepted as the intensity of pain felt at that moment. application after 120 minute
Secondary Postpartum Comfort Scale-First follow up Postpartum Comfort Scale: It is a scale that can be used to measure the postpartum comfort of mothers who delivered vaginally or by cesarean section. The PCS consists of a 5-point Likert-type scale scoring system and 34 items. I totally agree with positive sentences shows the best comfort (5 points), and negative sentences show low comfort (1 point). Accordingly, the lowest score to be taken from the scale is 34, and the highest score is 170. The average value is determined by dividing the total score obtained from the scale by the number of items, and the result is shown in the 1-5 distribution.High scores on the scale indicate increased comfort. application after 30 minute
Secondary Postpartum Comfort Scale -Second follow up Postpartum Comfort Scale: It is a scale that can be used to measure the postpartum comfort of mothers who delivered vaginally or by cesarean section. The PCS consists of a 5-point Likert-type scale scoring system and 34 items.I totally agree with positive sentences shows the best comfort (5 points), and negative sentences show low comfort (1 point). Accordingly, the lowest score to be taken from the scale is 34, and the highest score is 170. The average value is determined by dividing the total score obtained from the scale by the number of items, and the result is shown in the 1-5 distribution.High scores on the scale indicate increased comfort. application after 60 minute
Secondary Postpartum Comfort Scale -Third follow up Postpartum Comfort Scale: It is a scale that can be used to measure the postpartum comfort of mothers who delivered vaginally or by cesarean section. The PCS consists of a 5-point Likert-type scale scoring system and 34 items. I totally agree with positive sentences shows the best comfort (5 points), and negative sentences show low comfort (1 point). Accordingly, the lowest score to be taken from the scale is 34, and the highest score is 170. The average value is determined by dividing the total score obtained from the scale by the number of items, and the result is shown in the 1-5 distribution. High scores on the scale indicate increased comfort. application after 120 minute
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