COMBINED EFFECTS OF PELVIC FLOOR ACTIVATION EXERCISES AND BENSON RELAXATION TECHNIQUE ON PAIN, URINARY INCONTINENCE AND FUNCTIONAL ABILITY AMONG POST– CESAREAN PATIENTS
To determine the combined effects of pelvic floor activation exercises and Benson
relaxation technique on pain, urinary incontinence and functional ability among postcesarean patients.
Design
It will Single blinded randomized clinical trial with parallel group design. 30 Participants will be allocated to two groups equally.
Settings and conduct
Arif Memorial Teaching Hospital
Participants/Inclusion and exclusion criteria
Inclusion Criteria
• Women aged 20 to 42 at 7 to 14 weeks after delivery or cesarean section
Experiencing pain in the pelvic region post-cesarean section.
• Patient's BMI did not surpass 30 kg/m2 primiparous and mild-degree SUI
• Presented with symptoms of urinary incontinence.
• Patients who were not currently undergoing any other specific pelvic floor
rehabilitation program.
Exclusion Criteria
• Individuals with cognitive impairments or communication difficulties that may hinder
participation in the study.
• Patients with active infections or complications related to the cesarean section incision
site.
• Patients with severe medical conditions that may limit their ability to perform the
prescribed exercises or relaxation techniques.
Patients undergoing treatment for pelvic floor issues with interventions that may
interfere with the study outcomes. presence of hypertension, diabetes, genital prolapse,
and smoking.
Intervention groups
Group A will receive Pelvic floor activation exercises with Benson relaxation technique. Pelvic floor activation exercises will be performed for 4 weeks and five times in a week.
Group B will receive Pelvic floor activation exercises only. Benson relaxation technique will be performed for 4 weeks and five times in a week.
Main outcome variables
Pain: Numeric pain rating scale
Urinary incontinence: International Consultation on Incontinence Questionnaire-Urinary
Incontinence Short Form
Functional ability: Functional Independence Measure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220701055331N5
Registration date:2025-03-27, 1404/01/07
Registration timing:registered_while_recruiting
Last update:2025-03-27, 1404/01/07
Update count:0
Registration date
2025-03-27, 1404/01/07
Registrant information
Name
Ifra Zulqarnain Awan
Name of organization / entity
Rashid Latif Medical College
Country
Pakistan
Phone
+92 333 4975431
Email address
ifra.awan@rlmc.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-25, 1404/01/05
Expected recruitment end date
2025-07-25, 1404/05/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
COMBINED EFFECTS OF PELVIC FLOOR ACTIVATION EXERCISES AND BENSON RELAXATION TECHNIQUE ON PAIN, URINARY INCONTINENCE AND FUNCTIONAL ABILITY AMONG POST– CESAREAN PATIENTS
Public title
COMBINED EFFECTS OF PELVIC FLOOR ACTIVATION EXERCISESAND BENSON RELAXATION TECHNIQUE ON PAIN, URINARYINCONTINENCE AND FUNCTIONAL ABILITY AMONG POST–CESAREAN PATIENTS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 20 to 42 at 7 to 14 weeks after delivery or cesarean sectionExperiencing pain in the pelvic region post-cesarean section.
Patient's BMI did not surpass 30 kg/m2 primiparous and mild-degree SUI
Presented with symptoms of urinary incontinence
Patients who were not currently undergoing any other specific pelvic floorrehabilitation program.
Exclusion criteria:
Individuals with cognitive impairments or communication difficulties that may hinderparticipation in the study.
Patients with active infections or complications related to the cesarean section incisionsite.
Patients with severe medical conditions that may limit their ability to perform theprescribed exercises or relaxation techniques.
Patients undergoing treatment for pelvic floor issues with interventions that mayinterfere with the study outcomes. presence of hypertension, diabetes, genital prolapse,and smoking.
Age
From 20 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random computer number generator will be used for randomization. Assign unique identification numbers to participants, then use a reliable software tool to generate a list of random numbers. Match these numbers to participant IDs and allocate individuals to different study groups based on the sorted random numbers. Ensure that the randomization process is concealed and documented for transparency and integrity.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blinding in a study involves keeping the outcome assessor blind to the intervention received by the participants. This helps to minimize bias in assessing the study outcomes. To achieve single blinding, the outcome assessor is not informed about the treatment allocation of the participants and remains unaware of which group received the intervention being studied.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board of Rashid Latif Medical College, Lahore.
Street address
35-KM Ferozepur Road Lahore
City
Lahore
Postal code
54600
Approval date
2024-09-26, 1403/07/05
Ethics committee reference number
IRB/2024/182
Health conditions studied
1
Description of health condition studied
Post-Cesarean Patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Numeric pain rating scale to measure pain
2
Description
Urinary incontinence
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
International Consultation on Incontinence Questionnaire-UrinaryIncontinence Short Form (ICIQ-UI SF)
3
Description
Functional ability
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Functional Independence Measure (FIM)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pelvic floor activation exercises with Benson relaxation technique. It will be performed for 4 weeks and five times in a week.
Category
Rehabilitation
2
Description
Intervention group: Pelvic floor activation exercises. It will be performed for 4 weeks and five times in a week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Arif Memorial Teaching Hospital
Full name of responsible person
Dr. Ifra Zulqarnain Awan
Street address
35-km ferozepur road Lahore
City
Lahore
Postal code
54600
Phone
+92 333 4975431
Email
ifra.awan@rlmc.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rashid latif medical college
Full name of responsible person
Ifra Zulqarnain Awan
Street address
35-km ferozepur road lahore
City
lahore
Postal code
54600
Phone
+92 333 4975431
Email
ifra.awan@rlmc.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rashid Latif Medical College
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rashid latif medical college
Full name of responsible person
Malaika Sajid Sidhu
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-km ferozepur road lahore
City
lahore
Province
punjab
Postal code
54600
Phone
+92 304 3044494
Email
malaikasidhu@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Ifra Zulqarnain Awan
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Rashid Latif Medical College 35-km Ferozpur Road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 333 4975431
Fax
Email
ifra.awan@rlmc.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Ifra Zulqarnain Awan
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Rashid Latif Medical College 35-km Ferozpur Road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 333 4975431
Fax
Email
ifra.awan@rlmc.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available