Cesarean Section ComplicationsNCT05856097
Kinesio Taping With and Without Diaphragmatic Breathing in Women After Cesarean Section
A study testing kinesio taping with diaphragmatic breathing and kinesio taping without diaphragmatic breathing in people with Cesarean Section Complications, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cesarean section is a major abdominal surgery and major challenge of it is to manage the pain and make the patient mobile .In spite of the advantageous effects of kinesio taping and diaphragmatic breathing, limited, data reported to study analgesic effects on pain management and mobility restoration in acute phase of… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- kinesio taping with diaphragmatic breathing and kinesio taping without diaphragmatic breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 4 May 2023to 3 Oct 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primiparous patients
- Participants having no serious medical illness
Who cannot join
- Multi gravida patients
- Any serious morbidity
- Patient gone through any other abdominal surgery except of cesarean section
- Patients with the infectious wound
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
District head quarter hospital jhang
Jhang, Punjab Province, 35200
Hafiza Mehjabeen, 03026577666, hafiza.mehjabeen@riphah.edu.pk
Farwa Batool, MS-WHPT*
About this study
Official title: Effects of Kinesio Taping With and Without Diaphragmatic Breathing on Incisional Pain and Mobility in Women After Cesarean Section
Cesarean section is a major abdominal surgery and major challenge of it is to manage the pain and make the patient mobile .In spite of the advantageous effects of kinesio taping and diaphragmatic breathing, limited, data reported to study analgesic effects on pain management and mobility restoration in acute phase of cesarean section.. This study will aim to meet the dares which are associated with cesarean section by reducing the incisional pain associated with improvement in physical mobility as a non-pharmacological treatment.
Read the detailed description
In year 2022 conducted a study to evaluate the effects of kinesio taping with the breathing exercises on the management of pain after c section .Their title of study was The effects of Kinesio taping and breathing exercises on pain management after gynaecological abdominal surgery: A randomized controlled study. This study was conducted among 132 participants between June 2017 and 18.kinesio taping was applied immediately after the surgery and on the post op day 1, 2, 3 breathing exercises were performed for 30 mins three times a day. Their study concluded that kinesio taping is a reliable method to cover up the acute pain in the gynaecological abdominal surgery.
In the year 2022 a study was conducted with the title The effects of kinesio tape on low back pain and disability in pregnant women to scrutinize the effects of kinesio taping on low back pain and disability in pregnant females. It was a single blind clinical trial including 80 pregnant females. Two randomly assigned groups were made of in which pain was assessed by VAS before and after application of kinesio taping on the day 1st,2nd,7th,and 14th. Disability was measured by Roland-Morris disability questionnaire before and after intervention on day 7th and 14th. Their result concludes that kinesio taping have lasting effects on low back pain disability and reduced disability was noticed .In the year 2020 another study was conducted to study the effects of KT on the pain, anxiety, menstrual cramps in the women with primary dysmenorrhea with the comparison with control and sham tape.51 women with the PD were categorized in the three groups KT, sham tape and control group. KT was applied at the sacral and supra pubic region with the ligament technique in KT group and applied on the trochanter major with no technique in the sham tape group. Pain, anxiety level, and menstrual complaints were examined before and after intervention. Their was positive response of the study responding to the decrease in anxiety level menstrual cramps and pain.
To the best of researchers knowledge, there is not enough literature present which can justify the efficacy of these interventions in a justified manner. Data is not sufficient that supports combined efficacy of these two interventions after cesarean section regarding pain management and mobility.
- Conditions
- Cesarean Section Complications
- Being tested
- kinesio taping with diaphragmatic breathing, kinesio taping without diaphragmatic breathing
- Keywords
- Ache, Breathing Exercises
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesio taping with diaphragmatic breathingOther
.kinesio tape was applied on1st day of intervention with the 20 minutes session of diaphragmatic breathing 3 sessions were given
kinesio taping without diaphragmatic breathingOther
kinesio tape was applied day 1st of intervention. 3 sessions were given
| Study group | Role | What they receive |
|---|---|---|
| kinesio taping with diaphragmatic breathing | Experimental | kinesio taping application with diaphragmatic breathing Receives: Other: kinesio taping with diaphragmatic breathing |
| kinesio taping without diaphragmatic breathing | Active comparator | kinesio taping application without diaphragmatic breathing Receives: Other: kinesio taping without diaphragmatic breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
Changes from baseline A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
Measured: 4th week
bedside mobility assessment tool (BMAT)
Changes from baseline BMAT is a tool designed for nurses to assess patient mobility in acute care. The BMAT allows nurses (and other healthcare workers) to determine the appropriate patient handling and mobility equipment or device to safely move or mobilize the patient. It consists of four steps, first is sit and shake, second is stretch and point ,third is stand and fourth is step. Mobility level 1,2,3and 4 is given to patients according to their level of mobility.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start4 May 2023
- Primary completion3 Sep 2023 (estimated)
- Study completion3 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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 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
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Mehjabeen, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856097
- Sponsor's protocol ID
- REC/RCR&AHS/23/0519
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
WHO Recommendations Non-Clinical Interventions to Reduce Unnecessary Caesarean Sections. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK532672/
PubMed 30398818Weckesser A, Farmer N, Dam R, Wilson A, Morton VH, Morris RK. Women's perspectives on caesarean section recovery, infection and the PREPS trial: a qualitative pilot study. BMC Pregnancy Childbirth. 2019 Jul 15;19(1):245. doi: 10.1186/s12884-019-2402-8.
PubMed 31307417Singla N, Garg K, Jain R, Malhotra A, Singh MR, Grewal A. Analgesic efficacy of dexamethasone versus dexmedetomidine as an adjuvant to ropivacaine in ultrasound-guided transversus abdominis plane block for post-operative pain relief in caesarean section: A prospective randomised controlled study. Indian J Anaesth. 2021 Sep;65(Suppl 3):S121-S126. doi: 10.4103/ija.IJA_228_21. Epub 2021 Sep 15.
PubMed 34703057Toprak Celenay S, Kavalci B, Karakus A, Alkan A. Effects of kinesio tape application on pain, anxiety, and menstrual complaints in women with primary dysmenorrhea: A randomized sham-controlled trial. Complement Ther Clin Pract. 2020 May;39:101148. doi: 10.1016/j.ctcp.2020.101148. Epub 2020 Mar 18.
PubMed 32379680Aalishahi T, Maryam-Lotfipur-Rafsanjani S, Ghorashi Z, Sayadi AR. The Effects of Kinesio Tape on Low Back Pain and Disability in Pregnant Women. Iran J Nurs Midwifery Res. 2022 Jan 25;27(1):41-46. doi: 10.4103/ijnmr.IJNMR_291_20. eCollection 2022 Jan-Feb.
PubMed 35280198Shahbazi M, Sarrafzadeh J, Fatemi TS, Hafizi L. Effect of thoracic Kinesio taping on acute lumbar and leg pain in a pregnant woman: A case report. Sports Orthopaedics and Traumatology. 2021.
Espi-Lopez GV, Ingles M, Ferrando AC, Serra-Ano P. Effect of Kinesio taping on clinical symptoms in people with fibromyalgia: A randomized clinical trial. J Back Musculoskelet Rehabil. 2019;32(4):561-567. doi: 10.3233/BMR-171100.
PubMed 30530959Yilmaz S, Terzioglu F. The effects of Kinesio taping and breathing exercises on pain management after gynaecological abdominal surgery: A randomized controlled study. Int J Nurs Pract. 2023 Apr;29(2):e13088. doi: 10.1111/ijn.13088. Epub 2022 Aug 4.
PubMed 35929048Hamasaki H. Effects of Diaphragmatic Breathing on Health: A Narrative Review. Medicines (Basel). 2020 Oct 15;7(10):65. doi: 10.3390/medicines7100065.
PubMed 33076360Kuravskaya YV, Aravitskaya M. EFFECTIVENESS OF RECOVERY OF THE PSYCHO-EMOTIONAL AND PHYSICAL STATUS OF WOMEN WHO HAVE SUFFERED A CAESAREAN SECTION BY MEANS OF PHYSICAL THERAPY. Art of Medicine. 2022:50-5.
Mohamed 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.
Nugent SM, Lovejoy TI, Shull S, Dobscha SK, Morasco BJ. Associations of Pain Numeric Rating Scale Scores Collected during Usual Care with Research Administered Patient Reported Pain Outcomes. Pain Med. 2021 Oct 8;22(10):2235-2241. doi: 10.1093/pm/pnab110.
PubMed 33749760Rose A, Carter N, Vann C, Lloyd-Penza M, Andrusko M. Implementing Bedside Mobility Assessment Tool to Improve Patient Outcomes and Staff Communication. Medsurg Nursing. 2022;31(1):32-6.
Boynton T, Kumpar D, VanGilder C. The bedside mobility assessment tool 2.0. American Nurse Journal. 2020;15(7):15.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Kinesio Taping With and Without Diaphragmatic Breathing on Incisional Pain and Mobility in Women After Cesarean Section
- ClinicalTrials.gov ID
- NCT05856097
- Acronym / sponsor ID
- REC/RCR&AHS/23/0519
- Conditions
- Cesarean Section Complications
- Keywords
- Ache, Breathing Exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 3 Sep 2023 (estimated)
- Study completion
- 3 Oct 2023 (estimated)
- First posted
- 12 May 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.
Cesarean section is a major abdominal surgery and major challenge of it is to manage the pain and make the patient mobile .In spite of the advantageous effects of kinesio taping and diaphragmatic breathing, limited, data reported to study analgesic effects on pain management and mobility restoration in acute phase of cesarean section.. This study will aim to meet the dares which are associated with cesarean section by reducing the incisional pain associated with improvement in physical mobility as a non-pharmacological treatment.
Detailed description
In year 2022 conducted a study to evaluate the effects of kinesio taping with the breathing exercises on the management of pain after c section .Their title of study was The effects of Kinesio taping and breathing exercises on pain management after gynaecological abdominal surgery: A randomized controlled study. This study was conducted among 132 participants between June 2017 and 18.kinesio taping was applied immediately after the surgery and on the post op day 1, 2, 3 breathing exercises were performed for 30 mins three times a day. Their study concluded that kinesio taping is a reliable method to cover up the acute pain in the gynaecological abdominal surgery.
In the year 2022 a study was conducted with the title The effects of kinesio tape on low back pain and disability in pregnant women to scrutinize the effects of kinesio taping on low back pain and disability in pregnant females. It was a single blind clinical trial including 80 pregnant females. Two randomly assigned groups were made of in which pain was assessed by VAS before and after application of kinesio taping on the day 1st,2nd,7th,and 14th. Disability was measured by Roland-Morris disability questionnaire before and after intervention on day 7th and 14th. Their result concludes that kinesio taping have lasting effects on low back pain disability and reduced disability was noticed .In the year 2020 another study was conducted to study the effects of KT on the pain, anxiety, menstrual cramps in the women with primary dysmenorrhea with the comparison with control and sham tape.51 women with the PD were categorized in the three groups KT, sham tape and control group. KT was applied at the sacral and supra pubic region with the ligament technique in KT group and applied on the trochanter major with no technique in the sham tape group. Pain, anxiety level, and menstrual complaints were examined before and after intervention. Their was positive response of the study responding to the decrease in anxiety level menstrual cramps and pain.
To the best of researchers knowledge, there is not enough literature present which can justify the efficacy of these interventions in a justified manner. Data is not sufficient that supports combined efficacy of these two interventions after cesarean section regarding pain management and mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| kinesio taping with diaphragmatic breathing | Experimental | Other: kinesio taping with diaphragmatic breathingkinesio taping application with diaphragmatic breathing |
| kinesio taping without diaphragmatic breathing | Active comparator | Other: kinesio taping without diaphragmatic breathingkinesio taping application without diaphragmatic breathing |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Primiparous patients
- Participants having no serious medical illness
Key exclusion criteria (4 listed)
- Multi gravida patients
- Any serious morbidity
- Patient gone through any other abdominal surgery except of cesarean section
- Patients with the infectious wound
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 |
|---|---|---|
| kinesio taping with diaphragmatic breathing.kinesio tape was applied on1st day of intervention with the 20 minutes session of diaphragmatic breathing 3 sessions were given | Other | kinesio taping with diaphragmatic breathing |
| kinesio taping without diaphragmatic breathingkinesio tape was applied day 1st of intervention. 3 sessions were given | Other | kinesio taping without diaphragmatic breathing |
Primary outcome
Visual analogue scale
Time frame: 4th week
Changes from baseline A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
bedside mobility assessment tool (BMAT)
Time frame: 4th week
Changes from baseline BMAT is a tool designed for nurses to assess patient mobility in acute care. The BMAT allows nurses (and other healthcare workers) to determine the appropriate patient handling and mobility equipment or device to safely move or mobilize the patient. It consists of four steps, first is sit and shake, second is stretch and point ,third is stand and fourth is step. Mobility level 1,2,3and 4 is given to patients according to their level of mobility.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Background: PubMed 30398818WHO Recommendations Non-Clinical Interventions to Reduce Unnecessary Caesarean Sections. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK532672/
- Background: PubMed 31307417Weckesser A, Farmer N, Dam R, Wilson A, Morton VH, Morris RK. Women's perspectives on caesarean section recovery, infection and the PREPS trial: a qualitative pilot study. BMC Pregnancy Childbirth. 2019 Jul 15;19(1):245. doi: 10.1186/s12884-019-2402-8.
- Background: PubMed 34703057Singla N, Garg K, Jain R, Malhotra A, Singh MR, Grewal A. Analgesic efficacy of dexamethasone versus dexmedetomidine as an adjuvant to ropivacaine in ultrasound-guided transversus abdominis plane block for post-operative pain relief in caesarean section: A prospective randomised controlled study. Indian J Anaesth. 2021 Sep;65(Suppl 3):S121-S126. doi: 10.4103/ija.IJA_228_21. Epub 2021 Sep 15.
- Background: PubMed 32379680Toprak Celenay S, Kavalci B, Karakus A, Alkan A. Effects of kinesio tape application on pain, anxiety, and menstrual complaints in women with primary dysmenorrhea: A randomized sham-controlled trial. Complement Ther Clin Pract. 2020 May;39:101148. doi: 10.1016/j.ctcp.2020.101148. Epub 2020 Mar 18.
- Background: PubMed 35280198Aalishahi T, Maryam-Lotfipur-Rafsanjani S, Ghorashi Z, Sayadi AR. The Effects of Kinesio Tape on Low Back Pain and Disability in Pregnant Women. Iran J Nurs Midwifery Res. 2022 Jan 25;27(1):41-46. doi: 10.4103/ijnmr.IJNMR_291_20. eCollection 2022 Jan-Feb.
- BackgroundShahbazi M, Sarrafzadeh J, Fatemi TS, Hafizi L. Effect of thoracic Kinesio taping on acute lumbar and leg pain in a pregnant woman: A case report. Sports Orthopaedics and Traumatology. 2021.
- Background: PubMed 30530959Espi-Lopez GV, Ingles M, Ferrando AC, Serra-Ano P. Effect of Kinesio taping on clinical symptoms in people with fibromyalgia: A randomized clinical trial. J Back Musculoskelet Rehabil. 2019;32(4):561-567. doi: 10.3233/BMR-171100.
- Background: PubMed 35929048Yilmaz S, Terzioglu F. The effects of Kinesio taping and breathing exercises on pain management after gynaecological abdominal surgery: A randomized controlled study. Int J Nurs Pract. 2023 Apr;29(2):e13088. doi: 10.1111/ijn.13088. Epub 2022 Aug 4.
- Background: PubMed 33076360Hamasaki H. Effects of Diaphragmatic Breathing on Health: A Narrative Review. Medicines (Basel). 2020 Oct 15;7(10):65. doi: 10.3390/medicines7100065.
- BackgroundKuravskaya YV, Aravitskaya M. EFFECTIVENESS OF RECOVERY OF THE PSYCHO-EMOTIONAL AND PHYSICAL STATUS OF WOMEN WHO HAVE SUFFERED A CAESAREAN SECTION BY MEANS OF PHYSICAL THERAPY. Art of Medicine. 2022:50-5.
- 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 33749760Nugent SM, Lovejoy TI, Shull S, Dobscha SK, Morasco BJ. Associations of Pain Numeric Rating Scale Scores Collected during Usual Care with Research Administered Patient Reported Pain Outcomes. Pain Med. 2021 Oct 8;22(10):2235-2241. doi: 10.1093/pm/pnab110.
- 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.
Hafiza Mehjabeen 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 kinesio taping with diaphragmatic breathing and kinesio taping without diaphragmatic breathing in people with Cesarean Section Complications, 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 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 12 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: 4th week). 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?
On the ClinicalTrials.gov record for NCT05856097, which also lists 14 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 12 May 2023.