Cesarean Section; Complications, Wound, DehiscenceNCT06303245
Effects of Abdominal Binders and TENS on Puerperium Period After Cesarean Section
A study testing ABDOMINAL BINDERS and TENS in people with Cesarean Section; Complications, Wound, Dehiscence, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the combined effects of abdominal binders and TENS on post-operative pain, distress and constipation in puerperium period after cesarean section Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section; Complications, Wound, Dehiscence
- What is being tested?
- ABDOMINAL BINDERS and TENS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Feb 2023to 19 Aug 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants on early puerperium period having constipation and willing to participate.
- Primigravida
- Body mass index (BMI) less than 30 kg/m2
Who cannot join
- Laxatives-induced patients
- History of chronic constipation
- Post cesarean abdominal suture infection.
- People with chronic diseases, and who underwent non-routine or additional surgical procedures, such as hysterectomy, tubal ligation, and classical uterine incision.
- Participants with inability to tolerate the binder.
- Participants who show unwillingness to participate in the study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
PAF hospital and sheikh zayed hospital
Lahore, Punjab Province, 05499
About this study
Official title: Combined Effects of Abdominal Binders and TENS on Post-operative Pain, Distress and Constipation in Puerperium Period After Cesarean Section
To determine the combined effects of abdominal binders and TENS on post-operative pain, distress and constipation in puerperium period after cesarean section
- Being tested
- ABDOMINAL BINDERS, TENS
- Keywords
- Cesarean section, constipation, Post-operative pain, puerperium, TENS
- Medical subject headings
- Wounds and Injuries, Constipation, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABDOMINAL BINDERSOther
will be given abdominal binders along with basic physiotherapy care. Physiotherapy care will include sitting exercises such as deep breathing exercises, protected huffing technique will be performed to improve gases exchange and remove secretion. In supine exercises such as basic ROM, ankle pumps, pelvic rolling, leg sliding will be performed. Each exercise will be of 10 repetition. This exercise will be given for 2 days per week for 6 weeks. Along with these exercises education related postural management and breastfeeding positions will also be guided
TENSOther
will receive TENS with high frequency (F=100Hz and T=100μs), intensity according to patient's pain threshold, duration of 30 continuous minutes, 2 cm above and below incision, with electrodes transversally positioned and crossing the incision. Two treatment sessions will be done per week for the period of 6 weeks. This group will be given tens along with abdominal binders with basic physiotherapy care. (23) In this treatment female's abdomen will be measured by a standard inch tape, then, according to the abdominal circumference, the binder will be fastened for 6 weeks. The binder will be placed tightly at the lower abdominal level with the incision positioned at the middle part of the binder. Participants will be asked to note the time to record the duration of binder wearing before taking the break. The binder will be opened between 10 pm and 8 am. This group will be given abdominal binders along with basic physiotherapy care
| Study group | Role | What they receive |
|---|---|---|
| ABDOMINAL BINDERS | Experimental | Not described Receives: Other: ABDOMINAL BINDERS |
| TENS | Active comparator | Not described Receives: Other: TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
o Numeric Pain rating Scale
Numeric pain rating scale is a subjective measure 11 point numerical scale which is used to measure pain. Is scoring range In this scale 0 shows no pain and 10 shows worst pain imaginable. It has good reliability of 0.79 and validity of 0.96.
Measured: 6th week
o Symptom Distress scale
Symptom distress scale is a 13 item self-assessment scale with 13 symptoms like pain, fatigue, insomnia, lack of appetite, nausea, breathlessness, lack of concentration, lack of appetite and altered mood. It's scoring is done by using 5 point Likert scale where 1 shows least distress and 5 shows extreme distress. With a total score ranging from 13 to 65. It has a reliability of 0.821 and validity of 0.825.
Measured: 6th week
o PAC-SYM Questionnaire
The PAC-SYM is a tool which is used to assess the severity of constipation. It range is from 0 and 48. Less value shows less severity of constipation. The patients were then asked to rate the severity of each symptom in a 5-point Likert scale (0-4; absent to very severe) during the past 2 weeks. The items were further categorized into 3 domains: abdominal symptoms (question 1-4), rectal symptoms (question 5-7), and stool symptoms (question 8-12). It is a reliable tool with value of 0.66 and validity with value of 0.75
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start23 Feb 2023
- Primary completion1 Aug 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section; Complications, Wound, DehiscenceStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hina gul gul, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303245
- Sponsor's protocol ID
- REC/RCR&AHS/23/0579
- Status last verified
- Sep 2024
- First submitted
- 4 Mar 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferreira VB, Iuamoto LR, Hsing WT. Multidisciplinary management of musculoskeletal pain during pregnancy: A review of literature. Journal of the International Society of Physical and Rehabilitation Medicine. 2021;4(2):63-9.
Wakkar A, Patil SP. Assessment of knee and ankle proprioception during the third trimester of pregnancy and postpartum period among primiparous women: An observational longitudinal study. J Educ Health Promot. 2022 Jul 29;11:241. doi: 10.4103/jehp.jehp_311_22. eCollection 2022.
PubMed 36177431Jenabi E, Khazaei S, Bashirian S, Aghababaei S, Matinnia N. Reasons for elective cesarean section on maternal request: a systematic review. J Matern Fetal Neonatal Med. 2020 Nov;33(22):3867-3872. doi: 10.1080/14767058.2019.1587407. Epub 2019 Mar 8.
PubMed 30810436Mohamed H, Yousef A, Kamel H-E, Oweda K, Abdelsameaa G. Kinesio taping and strength recovery of postnatal abdominal muscles after cesarean section. Egyptian Journal of Physical Therapy. 2020;4(1):13-9
Verma V, Vishwakarma RK, Nath DC, Khan HTA, Prakash R, Abid O. Prevalence and determinants of caesarean section in South and South-East Asian women. PLoS One. 2020 Mar 12;15(3):e0229906. doi: 10.1371/journal.pone.0229906. eCollection 2020.
PubMed 32163440Kuronen M. Constipation and pain management after spine surgery and in pregnancy and postpartum: Itä-Suomen yliopisto; 2021.
Orlova D. MODERN POSSIBILITIES FOR CORRECTING CONSTIPATION IN POSTPARTUM WOMEN. Молодежный инновационный вестник. 2021;10(S1):29-32.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Abdominal Binders and TENS on Post-operative Pain, Distress and Constipation in Puerperium Period After Cesarean Section
- ClinicalTrials.gov ID
- NCT06303245
- Acronym / sponsor ID
- REC/RCR&AHS/23/0579
- Keywords
- Cesarean section, constipation, Post-operative pain, puerperium, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 12 Mar 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.
To determine the combined effects of abdominal binders and TENS on post-operative pain, distress and constipation in puerperium period after cesarean section
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABDOMINAL BINDERS | Experimental | Other: ABDOMINAL BINDERS |
| TENS | Active comparator | Other: TENS |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants on early puerperium period having constipation and willing to participate.
- Primigravida
- Body mass index (BMI) less than 30 kg/m2
Key exclusion criteria (6 listed)
- Laxatives-induced patients
- History of chronic constipation
- Post cesarean abdominal suture infection.
- People with chronic diseases, and who underwent non-routine or additional surgical procedures, such as hysterectomy, tubal ligation, and classical uterine incision.
- Participants with inability to tolerate the binder.
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 BINDERSwill be given abdominal binders along with basic physiotherapy care. Physiotherapy care will include sitting exercises such as deep breathing exercises, protected huffing technique will be performed to improve gases exchange and remove secretion. In supine exercises such as basic ROM, ankle pumps, pelvic rolling, leg sliding will be performed. Each exercise will be of 10 repetition. This exercise will be given for 2 days per week for 6 weeks. Along with these exercises education related postural management and breastfeeding positions will also be guided | Other | ABDOMINAL BINDERS |
| TENSwill receive TENS with high frequency (F=100Hz and T=100μs), intensity according to patient's pain threshold, duration of 30 continuous minutes, 2 cm above and below incision, with electrodes transversally positioned and crossing the incision. Two treatment sessions will be done per week for the period of 6 weeks. This group will be given tens along with abdominal binders with basic physiotherapy care. (23) In this treatment female's abdomen will be measured by a standard inch tape, then, according to the abdominal circumference, the binder will be fastened for 6 weeks. The binder will be placed tightly at the lower abdominal level with the incision positioned at the middle part of the binder. Participants will be asked to note the time to record the duration of binder wearing before taking the break. The binder will be opened between 10 pm and 8 am. This group will be given abdominal binders along with basic physiotherapy care | Other | TENS |
Primary outcome
o Numeric Pain rating Scale
Time frame: 6th week
Numeric pain rating scale is a subjective measure 11 point numerical scale which is used to measure pain. Is scoring range In this scale 0 shows no pain and 10 shows worst pain imaginable. It has good reliability of 0.79 and validity of 0.96.
o Symptom Distress scale
Time frame: 6th week
Symptom distress scale is a 13 item self-assessment scale with 13 symptoms like pain, fatigue, insomnia, lack of appetite, nausea, breathlessness, lack of concentration, lack of appetite and altered mood. It's scoring is done by using 5 point Likert scale where 1 shows least distress and 5 shows extreme distress. With a total score ranging from 13 to 65. It has a reliability of 0.821 and validity of 0.825.
o PAC-SYM Questionnaire
Time frame: 6th week
The PAC-SYM is a tool which is used to assess the severity of constipation. It range is from 0 and 48. Less value shows less severity of constipation. The patients were then asked to rate the severity of each symptom in a 5-point Likert scale (0-4; absent to very severe) during the past 2 weeks. The items were further categorized into 3 domains: abdominal symptoms (question 1-4), rectal symptoms (question 5-7), and stool symptoms (question 8-12). It is a reliable tool with value of 0.66 and validity with value of 0.75
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 4 Sep 2024.
- BackgroundFerreira VB, Iuamoto LR, Hsing WT. Multidisciplinary management of musculoskeletal pain during pregnancy: A review of literature. Journal of the International Society of Physical and Rehabilitation Medicine. 2021;4(2):63-9.
- Background: PubMed 36177431Wakkar A, Patil SP. Assessment of knee and ankle proprioception during the third trimester of pregnancy and postpartum period among primiparous women: An observational longitudinal study. J Educ Health Promot. 2022 Jul 29;11:241. doi: 10.4103/jehp.jehp_311_22. eCollection 2022.
- Background: PubMed 30810436Jenabi E, Khazaei S, Bashirian S, Aghababaei S, Matinnia N. Reasons for elective cesarean section on maternal request: a systematic review. J Matern Fetal Neonatal Med. 2020 Nov;33(22):3867-3872. doi: 10.1080/14767058.2019.1587407. Epub 2019 Mar 8.
- BackgroundMohamed H, Yousef A, Kamel H-E, Oweda K, Abdelsameaa G. Kinesio taping and strength recovery of postnatal abdominal muscles after cesarean section. Egyptian Journal of Physical Therapy. 2020;4(1):13-9
- Background: PubMed 32163440Verma V, Vishwakarma RK, Nath DC, Khan HTA, Prakash R, Abid O. Prevalence and determinants of caesarean section in South and South-East Asian women. PLoS One. 2020 Mar 12;15(3):e0229906. doi: 10.1371/journal.pone.0229906. eCollection 2020.
- BackgroundKuronen M. Constipation and pain management after spine surgery and in pregnancy and postpartum: Itä-Suomen yliopisto; 2021.
- BackgroundOrlova D. MODERN POSSIBILITIES FOR CORRECTING CONSTIPATION IN POSTPARTUM WOMEN. Молодежный инновационный вестник. 2021;10(S1):29-32.
- 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.
hina gul gul principal investigator
Riphah International 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 ABDOMINAL BINDERS and TENS in people with Cesarean Section; Complications, Wound, Dehiscence, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 6 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 4 Sep 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 Pakistan. 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?
o Numeric Pain rating Scale (time frame: 6th week). The study lists 3 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 NCT06303245, which also lists 7 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 4 Sep 2024.