Cesarean Section ComplicationsNCT05312515
The Effect of Hot Bag/Warm Application on Feet After Cesarean Delivery on Postpartum Comfort, Pain and Flatus
A study testing Warm Application to Feet in people with Cesarean Section Complications and Pain, run by Selcuk University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Pain, Postpartum Anxiety
- What is being tested?
- Warm Application to Feet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 30 Dec 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- giving birth to a live baby
- No diagnosed psychological disorder
- Women who do not pass gas before applying heat
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Ali Kemal Belviranlı Gynecology and Pediatrics Hospital
Konya
About this study
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.
Read the detailed 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.
- Conditions
- Cesarean Section Complications, Pain, Postpartum Anxiety
- Being tested
- Warm Application to Feet
- Keywords
- Cesarean Section, Pain, Postpartum Comfort
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm Application to FeetOther
Warm Application to Feet after Cesarean Section
| Study group | Role | What they receive |
|---|---|---|
| Warm Application to Feet and Follow-up After Cesarean Section | Experimental | Warm application will be applied to the feet of women who come to the surgical service after cesarean delivery, 3 hours after they are admitted to the service. For hot application, a hot water bag will be used, the temperature of the water to be placed in the hot water bag is max. It will be set by the researcher to be 44°C. Since the temperature of the water (max. 44°C) does not create a risk of burns, no additional precautions were required. A stopwatch clock will be used to track the duration of the application. After the application will be done for 30 minutes, a hot water bag will be taken. Hot application will be done once. During the application, the researcher will be with the women, will check whether any complications have developed, and if complications or discomfort develop, the application will be terminated. Receives: Other: Warm Application to Feet |
| Control | No intervention | The control group will be given routine post-operative care without any intervention and data collection tools will be applied at the same time as the intervention group. In addition, the patient and his family will be informed to write it down with the watch if there is gas after the procedure when the researcher is not with them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the beginning of the study
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.
Measured: application after 30 minute
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.
Measured: application after 60 minute
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.
Measured: application after 120 minute
Secondary outcomes (6)
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.
Measured: application after 30 minute
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.
Measured: application after 60 minute
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.
Measured: application after 120 minute
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.
Measured: application after 30 minute
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.
Measured: application after 60 minute
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.
Measured: application after 120 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Apr 2021
- Primary completion1 Mar 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- In order to ensure randomization in the study, a random numbers table was created by dividing into two groups out of 238 samples by taking 10% more than the number of samples determined on the site https://www.randomizer.org/. In order to avoid bias, the assignment of women to the intervention and control groups according to the randomization list will be determined by a midwife working in the clinic, who is not one of the study authors. In the study, the CONSORT scheme will be followed during the application.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin ERKAL AKSOY, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312515
- Sponsor's protocol ID
- 0000-0002-7453-1205
- Status last verified
- Jan 2025
- First submitted
- 23 Mar 2022
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Büyükkayacı Duman N, Karataş N. Sezaryen Sonrası Erken Taburcu Olan Kadınlara Verilen Evde Bakım Hizmetinin Anne Sağlığına Ve Öz Bakım Gücüne Etkisi. Sağlık 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.
PubMed 28502203Sutton 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.
PubMed 28131114Sell 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hot Bag/Warm Application on Feet After Cesarean Delivery on Postpartum Comfort, Pain and Flatus
- ClinicalTrials.gov ID
- NCT05312515
- Acronym / sponsor ID
- 0000-0002-7453-1205
- Conditions
- Cesarean Section Complications, Pain, Postpartum Anxiety
- Keywords
- Cesarean Section, Pain, Postpartum Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 5 Apr 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 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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- In order to ensure randomization in the study, a random numbers table was created by dividing into two groups out of 238 samples by taking 10% more than the number of samples determined on the site https://www.randomizer.org/. In order to avoid bias, the assignment of women to the intervention and control groups according to the randomization list will be determined by a midwife working in the clinic, who is not one of the study authors. In the study, the CONSORT scheme will be followed during the application.
| Arm | Type | Receives |
|---|---|---|
| Warm Application to Feet and Follow-up After Cesarean Section | Experimental | Other: Warm Application to FeetWarm application will be applied to the feet of women who come to the surgical service after cesarean delivery, 3 hours after they are admitted to the service. For hot application, a hot water bag will be used, the temperature of the water to be placed in the hot water bag is max. It will be set by the researcher to be 44°C. Since the temperature of the water (max. 44°C) does not create a risk of burns, no additional precautions were required. A stopwatch clock will be used to track the duration of the application. After the application will be done for 30 minutes, a hot water bag will be taken. Hot application will be done once. During the application, the researcher will be with the women, will check whether any complications have developed, and if complications or discomfort develop, the application will be terminated. |
| Control | No intervention | –The control group will be given routine post-operative care without any intervention and data collection tools will be applied at the same time as the intervention group. In addition, the patient and his family will be informed to write it down with the watch if there is gas after the procedure when the researcher is not with them. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- over 18 years old
- Can read and understand Turkish
- No history of any medical illness
- Singular pregnancy
- No complications during or after surgery
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Warm Application to FeetWarm Application to Feet after Cesarean Section | Other | Warm Application to Feet and Follow-up After Cesarean Section |
Primary outcome
Introductory Information Form
Time frame: at the beginning of the study
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.
Post Cesarean Section Follow-up Form-First follow up
Time frame: application after 30 minute
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.
Post Cesarean Section Follow-up Form-Second follow up
Time frame: application after 60 minute
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.
Post Cesarean Section Follow-up Form-Third follow up
Time frame: application after 120 minute
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.
6 secondary outcomes
Visual Pain Scale (VAS)-First follow up
Time frame: application after 30 minute
Visual Pain Scale (VAS)-Second follow up
Time frame: application after 60 minute
Visual Pain Scale (VAS)-Third follow up
Time frame: application after 120 minute
Postpartum Comfort Scale-First follow up
Time frame: application after 30 minute
Postpartum Comfort Scale -Second follow up
Time frame: application after 60 minute
Postpartum Comfort Scale -Third follow up
Time frame: application after 120 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- BackgroundBüyükkayacı Duman N, Karataş N. Sezaryen Sonrası Erken Taburcu Olan Kadınlara Verilen Evde Bakım Hizmetinin Anne Sağlığına Ve Öz Bakım Gücüne Etkisi. Sağlık Bil Derg 2011, 20(1):54-67.
- Background: PubMed 28502203Ciardulli 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.
- Background: PubMed 28131114Sutton 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.
- Results publicationSell 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm Application to Feet in people with Cesarean Section Complications and Pain, run by Selcuk University at 1 site in Turkey (Türkiye).
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Introductory Information Form (time frame: at the beginning of the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05312515, which also lists 4 linked publications.
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 30 Jan 2025.