To find the comparative effects of Transcutaneous Electrical nerve stimulation and labor exercises on pain, duration and behavioral response of primigravida women.
Design
Study design was randomized control trial
Settings and conduct
Study Setting was Gynecological Department, Social Security Hospital, Multan Road, Lahore.
Participants/Inclusion and exclusion criteria
Inclusion criteria encompassed females aged 20-35, primigravida women at 38 to 40 weeks' gestation, experiencing the first stage of labor with cervical dilation between 3 to 4 centimeters. Exclusion criteria included females with uterine issues, cervical cerclage, hypertension, urinary incontinence, or diagnosed psychological issues.
Intervention groups
Both groups received transcutaneous electrical nerve stimulation as conventional therapy. Group A received TENS along with labor exercises, while Group B received TENS without labor exercises.
COMPARATIVE EFFECTS OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION AND LABOR EXERCISES ON PAIN, DURATION AND BEHAVIORAL RESPONSE OF PRIMIGRAVIDA WOMEN
Public title
comparison of TENS with and without labor exercises during labor.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Females
20-35 years
Primigravida women with 38 weeks to 40 weeks’ gestation
First stage of labor
Cervical dilatation 3 cms to 4 cms as per vaginal findings
Physically Active
Exclusion criteria:
Female with any other uterine issue
Cervical cerclage
Hypertension
Urinary Incontinence
Diagnosed Psychological issues.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
52
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
All the screened and willing participants was randomly allocated to two groups by lottery method.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study was a single blinded study in which the assessor was kept blinded.
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee
Street address
University of Lahore near bhuptian chowk,1km defense road, Lahore
City
Lahore
Postal code
54000
Approval date
2023-09-27, 1402/07/05
Ethics committee reference number
REC-UOL-565-10-2023
Health conditions studied
1
Description of health condition studied
Labor is one of the most thrilling times in a women’s life. Pregnant women typically have intense pain during this time. Both pharmaceutical and non-pharmacological methods exist for treating pain, and a variety of factors, such as psychological aspects or traumatic experiences in the past, can alter how pain is perceived.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
5 times after intervention with 45 mins interval
Method of measurement
Wong baker faces pain scale
2
Description
Behavioral Response
Timepoint
5 times after intervention with 45 mins interval
Method of measurement
behavioral pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group A: Transcutaneous Electrical Nerve Stimulation (TENS) with Labor exercises. The study included two distinct groups: experimental and control. Participants in the experimental group had both Transcutaneous Electrical Nerve Stimulation (TENS) therapy and particular labor exercises. They were briefed on the functionality and benefits of TENS and given demonstrations. TENS electrodes were placed at the T10-L1 area. TENS was applied for 5 mins with continuous mode (frequency 150 Hz) and 5 sets of labor exercises having 5 repetitions each with interval of 45 minutes. In addition, the experimental group did labor exercises such as deep breathing, squatting, using birth balls, pelvic rocking, and lunges, Throughout the early labor period, the investigator encouraged and supported the primigravida women in the experimental group.
Category
Rehabilitation
2
Description
Control Group B: Transcutaneous Electrical Nerve Stimulation (TENS) without Labor exercises. The study included two participant groups: experimental and control. The control group only got Transcutaneous Electrical Nerve Stimulation. Participants in this group were given a demonstration of TENS’s benefits and functionality. TENS electrodes were then placed in the T10-L1 area, TENS was applied for 5 mins with continuous mode (frequency 150 Hz) and 5 sets of labor exercises having 5 repetitions each with interval of 45 minutes.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Punjab employees social security hospital (PESSI), Multan Road, Lahore
Full name of responsible person
Dr. Fariha Khalid
Street address
PESSI, Multan Road, Lahore
City
Lahore
Postal code
54000
Phone
+92 321 1043318
Email
fariha.khalid@dhpt.uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University Of Lahore
Full name of responsible person
Dr. Fariha Khalid
Street address
PESSI, Multan Road, Lahore
City
Lahore
Postal code
54000
Phone
+92 321 1043318
Email
fariha.khalid@dhpt.uol.edu.pk
Grant name
not applicable
Grant code / Reference number
no
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University Of Lahore
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
University Of Lahore
Full name of responsible person
Sara Khan
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
University Of lahore, 1-km defense road, near bhuptian chowk, Lahore
City
Lahore
Province
punjab
Postal code
54000
Phone
+92 300 4381040
Email
sara.khan@uipt.uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
University Of Lahore
Full name of responsible person
Dr.Fariha Khalid
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
University of lahore, 1-km defense road, near bhuptian chowk, lahore.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 321 1043318
Email
fariha.khalid@dhpt.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Sara Khan
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
University Of lahore 1 km defenseroad near bhuptian chowk Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 300 4381040
Email
sara.khan@uipt.uol.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
COMPARATIVE EFFECTS OF TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION AND LABOR EXERCISES ON PAIN, DURATION AND BEHAVIORAL RESPONSE OF PRIMIGRAVIDA WOMEN
When the data will become available and for how long
availale
To whom data/document is available
academic institutions
Under which criteria data/document could be used
SPSS
From where data/document is obtainable
Sara Khan
sara.kha3035@gmail.com
03004381040
What processes are involved for a request to access data/document