Effect of Abdominal Binders on Patient ( Pain, Quality of Recovery ) After Cesaean SectionNCT06564064
The Effect of Abdominal Binders on Patient's Wellbeing After Cesarean Delivery
A study testing abdominal binder in people with Effect of Abdominal Binders on Patient ( Pain, Quality of Recovery ) After Cesaean Section, run by Sohag University at 1 site in Egypt.
Trial summary
The effect of abdominal binders on patient's wellbeing after cesarean delivery Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Abdominal Binders on Patient ( Pain, Quality of Recovery ) After Cesaean Section
- What is being tested?
- abdominal binder
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2024to 15 Oct 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- any female post cesarean section of singleton 34 wks gestaion fetus with previous cs
Who cannot join
- primary cs any hypertensive disorder with pregnancy any neurologiacal disease general anasthesia or vertical incision
Trial locations and contacts
1 site in 1 country.
abdou s aitallah, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag, Sohag
magdy m amin, professor
About this study
Official title: The Effect of Abdominal Binders on Patient's Wellbeing After Cesarean Delivery :a Prospective Comparative Study
The effect of abdominal binders on patient's wellbeing after cesarean delivery
Read the detailed description
The effect of abdominal binders on patient's wellbeing after cesarean delivery 12 hours and one week after cesarean section
- Conditions
- Effect of Abdominal Binders on Patient ( Pain, Quality of Recovery ) After Cesaean Section
- Being tested
- abdominal binder
- Keywords
- binders, cesarean section , VAS, QOR 40
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal binderDevice
study group will be abdominal binders and control group will be control group , 12 hrs and one week later VAS and QOR 40 will assess patient,s wellbeing
| Study group | Role | What they receive |
|---|---|---|
| study group Study group(Group1) | Active comparator | 25 participant will be in study group (abdominal binders) Receives: Device: abdominal binder |
| Control group (Group 2) | Placebo comparator | 25 participants will be in control group Receives: Device: abdominal binder |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of abdominal binders on pain after cesarean section
abdominal binders will be fit on patient abdomin 2 hrs post cs and VAS will be assessed 12 hrs post cesarean section
Measured: 6 months
Secondary outcomes (1)
The effect of abdominal binders on patient's wellbeing after cesarean delivery
effect after one week on quality of recovery ( infection, hematoma, seroma) by QOR 40
Measured: one week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start15 Jul 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Effect of Abdominal Binders on Patient ( Pain, Quality of Recovery ) After Cesaean SectionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- study group (abdominal binders) and control group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Saad Abdellattif, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564064
- Sponsor's protocol ID
- Soh-Med-24-07-20MS
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ghana S, Hakimi S, Mirghafourvand M, Abbasalizadeh F, Behnampour N. Randomized controlled trial of abdominal binders for postoperative pain, distress, and blood loss after cesarean delivery. Int J Gynaecol Obstet. 2017 Jun;137(3):271-276. doi: 10.1002/ijgo.12134. Epub 2017 Mar 28.
PubMed 28241386Gustafson JL, Dong F, Duong J, Kuhlmann ZC. Elastic Abdominal Binders Reduce Cesarean Pain Postoperatively: A Randomized Controlled Pilot Trial. Kans J Med. 2018 May 18;11(2):1-19. eCollection 2018 May.
PubMed 29796155Karaca I, Ozturk M, Alay I, Ince O, Karaca SY, Erdogan VS, Ekin M. Influence of Abdominal Binder Usage after Cesarean Delivery on Postoperative Mobilization, Pain and Distress: A Randomized Controlled Trial. Eurasian J Med. 2019 Oct;51(3):214-218. doi: 10.5152/eurasianjmed.2019.18457.
PubMed 31692751Saeed S, Rage KA, Memon AS, Kazi S, Samo KA, Shahid S, Ali A. Use of Abdominal Binders after a Major Abdominal Surgery: A Randomized Controlled Trial. Cureus. 2019 Oct 3;11(10):e5832. doi: 10.7759/cureus.5832.
PubMed 31754567Terkawi AS, Tsang S, Abolkhair A, Alsharif M, Alswiti M, Alsadoun A, AlZoraigi US, Aldhahri SF, Al-Zhahrani T, Altirkawi KA. Development and validation of Arabic version of the Short-Form McGill Pain Questionnaire. Saudi J Anaesth. 2017 May;11(Suppl 1):S2-S10. doi: 10.4103/sja.SJA_42_17.
PubMed 28615999Terkawi AS, Myles PS, Riad W, Nassar SN, Mahmoud M, AlKahtani GJ, Sala FJ, Abdulrahman A, Doais KS, Terkawi RS, Tsang S. Development and validation of Arabic version of the postoperative quality of recovery-40 questionnaire. Saudi J Anaesth. 2017 May;11(Suppl 1):S40-S52. doi: 10.4103/sja.SJA_77_17.
PubMed 28616003
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Binders on Patient's Wellbeing After Cesarean Delivery :a Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT06564064
- Acronym / sponsor ID
- Soh-Med-24-07-20MS
- Conditions
- Effect of Abdominal Binders on Patient ( Pain, Quality of Recovery ) After Cesaean Section
- Keywords
- binders, cesarean section , VAS, QOR 40
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 21 Aug 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.
The effect of abdominal binders on patient's wellbeing after cesarean delivery
Detailed description
The effect of abdominal binders on patient's wellbeing after cesarean delivery 12 hours and one week after cesarean section
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- study group (abdominal binders) and control group
| Arm | Type | Receives |
|---|---|---|
| study group Study group(Group1) | Active comparator | Device: abdominal binder25 participant will be in study group (abdominal binders) |
| Control group (Group 2) | Placebo comparator | Device: abdominal binder25 participants will be in control group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- any female post cesarean section of singleton 34 wks gestaion fetus with previous cs
Key exclusion criteria (1 listed)
- primary cs any hypertensive disorder with pregnancy any neurologiacal disease general anasthesia or vertical incision
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 |
|---|---|---|
| abdominal binderstudy group will be abdominal binders and control group will be control group , 12 hrs and one week later VAS and QOR 40 will assess patient,s wellbeing | Device | Control group (Group 2), study group Study group(Group1) |
Primary outcome
The effect of abdominal binders on pain after cesarean section
Time frame: 6 months
abdominal binders will be fit on patient abdomin 2 hrs post cs and VAS will be assessed 12 hrs post cesarean section
1 secondary outcome
The effect of abdominal binders on patient's wellbeing after cesarean delivery
Time frame: one week postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 28241386Ghana S, Hakimi S, Mirghafourvand M, Abbasalizadeh F, Behnampour N. Randomized controlled trial of abdominal binders for postoperative pain, distress, and blood loss after cesarean delivery. Int J Gynaecol Obstet. 2017 Jun;137(3):271-276. doi: 10.1002/ijgo.12134. Epub 2017 Mar 28.
- Background: PubMed 29796155Gustafson JL, Dong F, Duong J, Kuhlmann ZC. Elastic Abdominal Binders Reduce Cesarean Pain Postoperatively: A Randomized Controlled Pilot Trial. Kans J Med. 2018 May 18;11(2):1-19. eCollection 2018 May.
- Background: PubMed 31692751Karaca I, Ozturk M, Alay I, Ince O, Karaca SY, Erdogan VS, Ekin M. Influence of Abdominal Binder Usage after Cesarean Delivery on Postoperative Mobilization, Pain and Distress: A Randomized Controlled Trial. Eurasian J Med. 2019 Oct;51(3):214-218. doi: 10.5152/eurasianjmed.2019.18457.
- Background: PubMed 31754567Saeed S, Rage KA, Memon AS, Kazi S, Samo KA, Shahid S, Ali A. Use of Abdominal Binders after a Major Abdominal Surgery: A Randomized Controlled Trial. Cureus. 2019 Oct 3;11(10):e5832. doi: 10.7759/cureus.5832.
- Background: PubMed 28615999Terkawi AS, Tsang S, Abolkhair A, Alsharif M, Alswiti M, Alsadoun A, AlZoraigi US, Aldhahri SF, Al-Zhahrani T, Altirkawi KA. Development and validation of Arabic version of the Short-Form McGill Pain Questionnaire. Saudi J Anaesth. 2017 May;11(Suppl 1):S2-S10. doi: 10.4103/sja.SJA_42_17.
- Background: PubMed 28616003Terkawi AS, Myles PS, Riad W, Nassar SN, Mahmoud M, AlKahtani GJ, Sala FJ, Abdulrahman A, Doais KS, Terkawi RS, Tsang S. Development and validation of Arabic version of the postoperative quality of recovery-40 questionnaire. Saudi J Anaesth. 2017 May;11(Suppl 1):S40-S52. doi: 10.4103/sja.SJA_77_17.
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.
abdou s aitallah, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal binder in people with Effect of Abdominal Binders on Patient ( Pain, Quality of Recovery ) After Cesaean Section, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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 21 Aug 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 Egypt. 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. Some participants in this study may receive a placebo. 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 esraa s abd ellatif, resident (01157145274, esraa011002@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of abdominal binders on pain after cesarean section (time frame: 6 months). 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 NCT06564064, which also lists 6 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 21 Aug 2024.