PainNCT05799547
The Effect of Cold Application on Patient's Pain, Comfort and Satisfaction After Cesarean Section
A study testing cold group in people with Pain, run by Osmaniye Korkut Ata University.
Trial summary
A healthy postpartum period is important for the health of the mother and baby. One of the main problems that occur after cesarean section, which is a major surgical procedure, is pain. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- cold group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2023to 20 Aug 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postpartum women who had cesarean section surgery
- Having had a previous cesarean section,
Who cannot join
- Those who have problems in postpartum vital signs and bleeding control
- Those who have systemic diseases that may affect cold application
- Those who are distressed and not suitable for practice by the service midwives and doctors,
- Those who do not want to participate in the research
About this study
Official title: The Effect of Cold Application on the Pain, Comfort and Satisfaction of the Patient on First Standing After Cesarean Section
A healthy postpartum period is important for the health of the mother and baby. One of the main problems that occur after cesarean section, which is a major surgical procedure, is pain. However, since the mother is in the postpartum period, she may have problems in her own care, healing process and baby care due to pain. Non-pharmacological treatment is methods such as massage, acupressure, hot and cold application that can be applied at birth to support scientific medicine. The cold application examined in our research, is among these applications. participants will be determined by the block randomization method. Cold application will be applied to the cesarean section site of the patient for 10 minutes in the experimental group, followed by a break of 20 minutes, followed by a 10-minute application, and immediately after the application, the patient will stand up. Only the routine practice of the clinic will be applied to the control group. Data; will be collected using the introductory information form, visual analog scale (VAS) and cold application satisfaction evaluation form. When the studies were examined, no other study was found in the same application as our study. Therefore, in this study, it was aimed to evaluate the effect of cold application on the patient's pain during the first leg, the need for painkillers and satisfaction, due to the higher first take-off pain after cesarean section.
- Conditions
- Pain
- Being tested
- cold group
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold groupOther
Application will be made in the form of 10 minutes of application to the cesarean section incision, 20 minutes of break and 10 minutes of application.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| experimental group | Experimental | Not described Receives: Other: cold group |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS)
The visual analog scale is used to assess pain. The person marks the pain he feels on a ten-centimeter chart that expresses the absence of pain on one side and the pain he feels at the peak on the other side.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start20 Jun 2023 (estimated)
- Primary completion10 Jul 2023 (estimated)
- Study completion20 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Yıldırım, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799547
- Sponsor's protocol ID
- 55555
- Status last verified
- Apr 2023
- First submitted
- 10 Jan 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Application on the Pain, Comfort and Satisfaction of the Patient on First Standing After Cesarean Section
- ClinicalTrials.gov ID
- NCT05799547
- Acronym / sponsor ID
- 55555
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (estimated)
- Primary completion
- 10 Jul 2023 (estimated)
- Study completion
- 20 Aug 2023 (estimated)
- First posted
- 5 Apr 2023 (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.
A healthy postpartum period is important for the health of the mother and baby. One of the main problems that occur after cesarean section, which is a major surgical procedure, is pain. However, since the mother is in the postpartum period, she may have problems in her own care, healing process and baby care due to pain. Non-pharmacological treatment is methods such as massage, acupressure, hot and cold application that can be applied at birth to support scientific medicine. The cold application examined in our research, is among these applications. participants will be determined by the block randomization method. Cold application will be applied to the cesarean section site of the patient for 10 minutes in the experimental group, followed by a break of 20 minutes, followed by a 10-minute application, and immediately after the application, the patient will stand up. Only the routine practice of the clinic will be applied to the control group. Data; will be collected using the introductory information form, visual analog scale (VAS) and cold application satisfaction evaluation form. When the studies were examined, no other study was found in the same application as our study. Therefore, in this study, it was aimed to evaluate the effect of cold application on the patient's pain during the first leg, the need for painkillers and satisfaction, due to the higher first take-off pain after cesarean section.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| experimental group | Experimental | Other: cold group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Postpartum women who had cesarean section surgery
- Having had a previous cesarean section,
Key exclusion criteria (4 listed)
- Those who have problems in postpartum vital signs and bleeding control
- Those who have systemic diseases that may affect cold application
- Those who are distressed and not suitable for practice by the service midwives and doctors,
- Those who do not want to participate in the research
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 |
|---|---|---|
| cold groupApplication will be made in the form of 10 minutes of application to the cesarean section incision, 20 minutes of break and 10 minutes of application. | Other | experimental group |
Primary outcome
visual analog scale (VAS)
Time frame: 1 week
The visual analog scale is used to assess pain. The person marks the pain he feels on a ten-centimeter chart that expresses the absence of pain on one side and the pain he feels at the peak on the other side.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
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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 cold group in people with Pain, run by Osmaniye Korkut Ata 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 2 inclusion and 4 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 5 Apr 2023. 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?
visual analog scale (VAS) (time frame: 1 week). 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 5 Apr 2023.