| CTRI Number |
CTRI/2024/10/075718 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Walking Vs Birthing Ball to Check the Progress of Labor among First time Pregnant Mothers. |
|
Scientific Title of Study
|
Effectiveness Of Perambulate Vs Birthing Ball on Progress of First Stage of Labour in Terms of Level of Pain and Satisfaction among Primi Parturient Mothers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thenesha k |
| Designation |
Research Scholar |
| Affiliation |
Bhaarath Institute of Higher Education and Research |
| Address |
Faculty of Nursing
Bhaarath Institute of Higher Education and Research
173 Agaram Main Road
Selaiyur Chennai
Tamilnadu 600073
Chennai
TAMIL NADU
600073
India |
| Phone |
9003538616 |
| Fax |
|
| Email |
thenesha.vino@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR S Vasantha |
| Designation |
Principal and Guide |
| Affiliation |
Bhaarath College of Nursing |
| Address |
Faculty of Nursing
Bhaarath College of Nursing Bhaarath Institute of Higher Education
and Research 173 Agaram Main Road Selaiyur Chennai Tamilnadu
600073
Chennai
TAMIL NADU
600073
India |
| Phone |
9444172674 |
| Fax |
|
| Email |
vasanthishanju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Thenesha k |
| Designation |
Research Scholar |
| Affiliation |
Bhaarath Institute of Higher Education and Research |
| Address |
Faculty of Nursing
Bhaarath Institute of Higher Education and Research
173 Agaram Main Road
Selaiyur Chennai
Tamilnadu 600073
Chennai
TAMIL NADU
600073
India |
| Phone |
9003538616 |
| Fax |
|
| Email |
thenesha.vino@gmail.com |
|
|
Source of Monetary or Material Support
|
| THIRUVALLUR GOVERNMENT MEDICAL COLLEGE AND HOSPITAL
SH57 HARIRAM NAGAR POONGA NAGAR KAKKALUR TAMILNADU 602001 |
|
|
Primary Sponsor
|
| Name |
THENESHA |
| Address |
Faculty of Nursing
Bhaarath Institute of Higher Education and Research
173 Agaram
Main Road Selaiyur Chennai Tamilnadu 600073 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| THENESHA |
THIRUVALLUR GOVERNMENT HOSPITAL |
Thiruvallur Government hospital
Department of Obstetrics
SH57 HARIRAM NAGAR POONGA NAGAR
KAKKALUR TAMILNADU 602001
Thiruvallur
TAMIL NADU |
9003538616
thenesha.vino@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaarath Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primi Para Mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Birthing Ball and Ambulation |
The investigator will conduct the study by selecting 200 primi Parturient mothers (100 in group I and 100 in group II) who fulfill the sample selection criteria by Simple Random Sampling Technique using lottery method. Based on that 20 Primi parturient mothers per day will be selected for the study. The parturient mothers who who will take No.1 (Ambulation) and assign to group A and parturient mothers who will take No.2 (Birthing Ball) will be assigned to group B Like this 200 samples will be selected. After selecting the samples the investigator will give a brief introduction about self and purpose of the study to both groups of parturient mothers and maintained good rapport to ensure that the mother is wide awake. They will be made to lie comfortably, explain the procedure and assured the confidentiality regarding data to win their cooperation during data collection. Informed written consent was obtained from the parturient mothers after clear explanation about the intervention
• After getting the consent, the intervention will be given to both group A and group B. The group A parturient mothers will be encouraged to walk for 10 to 15 minutes with a period of 10 minutes rest in left lateral position and continue till full cervical dilatation. The group B Parturient mothers who will be in the active phase of the first stage of labor (i.e., 4 cm cervical dilatation) were encouraged to practice in birthing ball for 15 minutes with a period of 10 minutes rest in left lateral position till full cervical dilatation. The exercises will be pelvic rocking forward and backward, ball bouncing and ball hip circle in a sitting position, and hugging the ball in a kneeling position for 15 minutes. Two, 15-minute exercise sessions with a subsequent gap of one hour during the active phase of labor will be given. Progress of Labour will be assessed using modified WHO Partograph. The labour pain level will be assessed by the Numerical pain intensity scale. The level of satisfaction on use of birthing ball and Ambulation will be assessed in the both the groups of primiparturient women using rating scale after delivery.
|
| Comparator Agent |
Birthing Ball Vs Ambulation |
Birthing ball and ambulation will be compared |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Female |
| Details |
admitted during the First stage of labour.
Post dated mothers
between the age group of 19 to 34 years.
with gestational age between 37 to 40 weeks .
with True labour to 4 cm dilatation
with singleton viable fetus with cephalic presentation
with intact membranes
who attain full cervical dilatation between 8am and 8pm.
who understands Tamil or English
|
|
| ExclusionCriteria |
| Details |
This study excludes primi Parturient mothers:
Who conceived by artificial reproductive technique.
Forewater rupture
Who have already received any information or attended any classes on Birthing ball.
Who are not giving consent to participate in the study.
Who are posted for Lower segmental caesarean section
with high-risk pregnancy such as Pregnancy induced hypertension, Gestational diabetes mellitus, Antepartum hemorrhage, Multiple pregnancy, Cephalo pelvic disproportion, Malposition, Malpresentation, Cord prolapse, Cord presentation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Birthing ball will be effective |
12 to 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Practicing birthing ball during labour will ease the delivery of the mothers.
|
12 to 24 hours |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Quazi experimental study , Randomized parallel control trial aims to assess the EFFECTIVENESS OF PERAMBULATE Vs BIRTHING BALL ON PROGRESS OF FIRST STAGE OF LABOUR IN TERMS OF LEVEL OF PAIN AND SATISFACTION AMONG PRIMI PARTURIENT MOTHERS. A total of 200 mothers will be included in the study. Based on that 20 Primi parturient mothers per day will be selected for the study. The parturient mothers who who will take No.1 (Ambulation) and assign to group A and parturient mothers who will take No.2 (Birthing Ball) will be assigned to group B Like this 200 samples will be selected. The labour pain level will be assessed by the Numerical pain intensity scale. The level of satisfaction on use of birthing ball and Ambulation will be assessed in the both the groups of primiparturient women using rating scale after delivery. |