Cesarean SectionNCT06262243
The Effect of Heating With Electrical Blanket After Cesarean Section on the Postpartum
A study testing electric blankets in people with Cesarean Section, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
It is known that maintaining and maintaining normal body temperature in women after cesarean section facilitates the mother's adaptation to the postpartum period. One of the important problems after cesarean section is hypothermia. Therefore, various methods are used to maintain normal body temperature. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- electric blankets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 1 Sep 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over,
- At least primary school graduate
- The one who is married
- Primiparous women who gave birth at term,
- Having the baby with her after birth
- Those who agreed to participate in the study
Who cannot join
- Those who gave birth at less than 37 weeks of gestation
- Mothers with babies weighing less than 2500 grams
- The newborn has a congenital anomaly,
- Those with a history of high-risk pregnancy
- Those who received any food, including water, other than breast milk until the 10th day of follow-up
- Those with cardiovascular disease problems, those with a history of neurological diseases
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- Mothers with nipple problems
- Diabetes Mellitus, those diagnosed with gestational diabetes mellitus,
- Mothers who gave birth with general anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Samsun Training and Research Hospital
Samsun, İ̇lkadim, 55080
TUBA ÇITAK, 05349265496, tubadlkc@gmail.com
Ebru ŞAHİN
About this study
Official title: The Effect of Heating With Electrical Blanket After Cesarean Section on the Postpartum Comfort, Pain, Milk Quantity and Breastfeeding Success
It is known that maintaining and maintaining normal body temperature in women after cesarean section facilitates the mother's adaptation to the postpartum period. One of the important problems after cesarean section is hypothermia. Therefore, various methods are used to maintain normal body temperature. One of these methods is the use of electric blankets. This study will investigate the effect of using electric blankets after cesarean section on postpartum comfort, pain, milk quantity and breastfeeding success.
Read the detailed description
After cesarean section, mothers face more problems than mothers who give birth normally. Post-cesarean pain, breastfeeding problems, anesthesia-related side effects, and postpartum complications are important reasons affecting maternal comfort. After a cesarean section, mothers may experience hypothermia due to the low temperature in the operating room, the incision, and the effects of spinal/general anesthesia. In mothers who develop hypothermia after cesarean section, undesirable results may occur in physiological parameters such as fever, pulse, blood pressure, pain, and intestinal motility. Therefore, body temperature, blood pressure, pulse, saturation, pain, time to first flatus and defecation are the main factors that determine patient comfort after surgery. In the postoperative period, both pharmacological and non-pharmacological treatment methods are used to reduce pain, increase the amount of milk, and increase intestinal motility. It is stated in the literature that non-pharmacological methods such as early mobilization, chewing gum, early oral hydration (consumption of water, warm water, tea, coffee), and hot application are effective in increasing intestinal motility. Using active and passive heating methods to prevent hypothermia after cesarean section are practices that affect postpartum comfort. With this study, it is expected that heating with an electric blanket will prevent hypothermia, increase postpartum comfort, reduce pain, and increase breastfeeding success by affecting the amount of milk.
- Conditions
- Cesarean Section
- Being tested
- electric blankets
- Keywords
- Caesarean section, electric blanket, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electric blanketsOther
While the patient is in surgery; An electric blanket will be placed under the bed mattress, and the bed will be placed on the electric blanket.
The bed sheet will be laid, and the blanket used in the clinic will be laid on top of the bed sheet.
-The electric blanket will be turned on at "hot" setting 20 minutes before the patient leaves the surgery. After the mother is placed in a heated bed, the electric blanket will be unplugged when the temperature reaches 36.5.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The group that will receive routine care and electric blankets after cesarean section. Receives: Other: electric blankets |
| control group | No intervention | The group that will receive routine care after cesarean section. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum comfort scale
Postpartum comfort scale, consists of 34 items. A 5-point Likert type scale scoring system was used. For each item, expressions and scoring ranging from "completely agree" (5 points) to "strongly disagree" (1 point) were made. Accordingly, the lowest score to be obtained from the scale is 34 and the highest score is 170.
Measured: two days
A Tool to Evaluate the Amount of Breast Milk the Baby Receives
It consists of 5 sections: urine amount, breast condition, stool amount, weight and satisfaction, and the features of each section are collected in 3 groups and evaluated out of 0, 1, 2 points. A full score of 10 was considered as the score where breast milk was obtained in the best possible way, and 7 and below were considered as the scores where the breast milk was obtained insufficiently.
Measured: ten days
Secondary outcomes (2)
Bristol Breastfeeding Assessment Tool
The scale was developed to evaluate common breastfeeding problems and adequacy in the postpartum period. The mother is observed by the midwife/nurse during breastfeeding, and the mother and baby are evaluated in line with the criteria and a form is filled out. The measurement tool is a Likert-type scale consisting of 4 items: "positioning", "holding", "sucking" and "swallowing".
Measured: two days
Insufficient Milk Perception Scale
The first question asks whether the mother perceives her milk to be sufficient. The mother answers this question with "yes" or "no". Other questions of the scale aim to measure the perception of inadequacy of milk. The mother is asked to score these questions between 0-10. "0" indicates that the milk is perceived as completely inadequate, and "10" indicates that the milk is perceived as completely sufficient. A minimum of 0 and a maximum of 50 points can be obtained from the scale.
Measured: two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start15 Jan 2024
- Primary completion30 Aug 2024 (estimated)
- Study completion1 Sep 2024 (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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research is a randomized controlled experimental design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tuba çıtak, Ordu University
- Investigators
- Ebru ŞAHİN, Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262243
- Sponsor's protocol ID
- ORDUU-HEM-TÇ-01
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Heating With Electrical Blanket After Cesarean Section on the Postpartum Comfort, Pain, Milk Quantity and Breastfeeding Success
- ClinicalTrials.gov ID
- NCT06262243
- Acronym / sponsor ID
- ORDUU-HEM-TÇ-01
- Conditions
- Cesarean Section
- Keywords
- Caesarean section, electric blanket, nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 15 Feb 2024 (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.
It is known that maintaining and maintaining normal body temperature in women after cesarean section facilitates the mother's adaptation to the postpartum period. One of the important problems after cesarean section is hypothermia. Therefore, various methods are used to maintain normal body temperature. One of these methods is the use of electric blankets. This study will investigate the effect of using electric blankets after cesarean section on postpartum comfort, pain, milk quantity and breastfeeding success.
Detailed description
After cesarean section, mothers face more problems than mothers who give birth normally. Post-cesarean pain, breastfeeding problems, anesthesia-related side effects, and postpartum complications are important reasons affecting maternal comfort. After a cesarean section, mothers may experience hypothermia due to the low temperature in the operating room, the incision, and the effects of spinal/general anesthesia. In mothers who develop hypothermia after cesarean section, undesirable results may occur in physiological parameters such as fever, pulse, blood pressure, pain, and intestinal motility. Therefore, body temperature, blood pressure, pulse, saturation, pain, time to first flatus and defecation are the main factors that determine patient comfort after surgery. In the postoperative period, both pharmacological and non-pharmacological treatment methods are used to reduce pain, increase the amount of milk, and increase intestinal motility. It is stated in the literature that non-pharmacological methods such as early mobilization, chewing gum, early oral hydration (consumption of water, warm water, tea, coffee), and hot application are effective in increasing intestinal motility. Using active and passive heating methods to prevent hypothermia after cesarean section are practices that affect postpartum comfort. With this study, it is expected that heating with an electric blanket will prevent hypothermia, increase postpartum comfort, reduce pain, and increase breastfeeding success by affecting the amount of milk.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research is a randomized controlled experimental design.
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: electric blanketsThe group that will receive routine care and electric blankets after cesarean section. |
| control group | No intervention | –The group that will receive routine care after cesarean section. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and over,
- At least primary school graduate
- The one who is married
- Primiparous women who gave birth at term,
- Having the baby with her after birth
Key exclusion criteria (9 listed)
- Those who gave birth at less than 37 weeks of gestation
- Mothers with babies weighing less than 2500 grams
- The newborn has a congenital anomaly,
- Those with a history of high-risk pregnancy
- Those who received any food, including water, other than breast milk until the 10th day of follow-up
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 |
|---|---|---|
| electric blanketsWhile the patient is in surgery; An electric blanket will be placed under the bed mattress, and the bed will be placed on the electric blanket. The bed sheet will be laid, and the blanket used in the clinic will be laid on top of the bed sheet. -The electric blanket will be turned on at "hot" setting 20 minutes before the patient leaves the surgery. After the mother is placed in a heated bed, the electric blanket will be unplugged when the temperature reaches 36.5. | Other | experimental group |
Primary outcome
Postpartum comfort scale
Time frame: two days
Postpartum comfort scale, consists of 34 items. A 5-point Likert type scale scoring system was used. For each item, expressions and scoring ranging from "completely agree" (5 points) to "strongly disagree" (1 point) were made. Accordingly, the lowest score to be obtained from the scale is 34 and the highest score is 170.
A Tool to Evaluate the Amount of Breast Milk the Baby Receives
Time frame: ten days
It consists of 5 sections: urine amount, breast condition, stool amount, weight and satisfaction, and the features of each section are collected in 3 groups and evaluated out of 0, 1, 2 points. A full score of 10 was considered as the score where breast milk was obtained in the best possible way, and 7 and below were considered as the scores where the breast milk was obtained insufficiently.
2 secondary outcomes
Bristol Breastfeeding Assessment Tool
Time frame: two days
Insufficient Milk Perception Scale
Time frame: two days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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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.
Ebru ŞAHİN principal investigator
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electric blankets in people with Cesarean Section, run by Ordu 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 6 inclusion and 9 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 15 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact TUBA ÇITAK (05349265496, tubadlkc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum comfort scale (time frame: two days). The study lists 2 primary outcomes in all. 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 15 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.