Effects of Abdominal Binders and TENS on Puerperium Period After Cesarean Section

NCT ID: NCT06303245

Last Updated: 2024-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-23

Study Completion Date

2024-08-19

Brief Summary

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To determine the combined effects of abdominal binders and TENS on post-operative pain, distress and constipation in puerperium period after cesarean section

Detailed Description

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Conditions

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Cesarean Section; Complications, Wound, Dehiscence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ABDOMINAL BINDERS

Group Type EXPERIMENTAL

ABDOMINAL BINDERS

Intervention Type OTHER

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

TENS

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type OTHER

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

Interventions

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ABDOMINAL BINDERS

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

Intervention Type OTHER

TENS

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants on early puerperium period having constipation and willing to participate.
* Primigravida
* Body mass index (BMI) less than 30 kg/m2

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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hina gul gul

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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PAF hospital and sheikh zayed hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 36177431 (View on PubMed)

Jenabi 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.

Reference Type BACKGROUND
PMID: 30810436 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 32163440 (View on PubMed)

Kuronen M. Constipation and pain management after spine surgery and in pregnancy and postpartum: Itä-Suomen yliopisto; 2021.

Reference Type BACKGROUND

Orlova D. MODERN POSSIBILITIES FOR CORRECTING CONSTIPATION IN POSTPARTUM WOMEN. Молодежный инновационный вестник. 2021;10(S1):29-32.

Reference Type BACKGROUND

Other Identifiers

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REC/RCR&AHS/23/0579

Identifier Type: -

Identifier Source: org_study_id

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