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

Cesarean Section; Complications, Wound, Dehiscence Clinical Trial

Official title:

Combined Effects of Abdominal Binders and TENS on Post-operative Pain, Distress and Constipation in Puerperium Period After Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06303245
• Other study ID #: REC/RCR&AHS/23/0579
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: imran amjad
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section; Complications, Wound, Dehiscence
• Constipation

Intervention

Other:
• 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
• 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

Locations

Country	Name	City	State
Pakistan	PAF hospital	Lahore

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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.

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. — View Citation

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

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

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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