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

NCT06303245 | Completed

• 1 other identifier: REC/RCR&AHS/23/0579
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cesarean Section; Complications, Wound, Dehiscence

Keywords

Cesarean section; constipation; Post-operative pain; puerperium; TENS

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  6th week

Study Arms (2)

ABDOMINAL BINDERS

EXPERIMENTAL

Other: ABDOMINAL BINDERS

TENS

ACTIVE COMPARATOR

Other: TENS

Interventions

ABDOMINAL BINDERS 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

ABDOMINAL BINDERS

TENS 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

TENS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: PUERPERIUM PERIOD AFTER CESAREAN SECTION
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

PAF hospital and sheikh zayed hospital

Lahore, Punjab Province, 05499, Pakistan

Location

Related Publications (7)

• 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.

  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.

  PMID: 36177431 BACKGROUND

• 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.

  PMID: 30810436 BACKGROUND

• 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

  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.

  PMID: 32163440 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Constipation; Pain, Postoperative

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• hina gul gul

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: February 23, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 19, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)