| CTRI Number |
CTRI/2023/09/057243 [Registered on: 04/09/2023] Trial Registered Prospectively |
| Last Modified On: |
09/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of video assisted teaching regarding child birth on labor behavior among first time mother: A Randomized control trial. |
|
Scientific Title of Study
|
Effect of video assisted teaching regarding child birth on intrapartum behavior among primigravida mothers: A Randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavitha P |
| Designation |
MSC Obstetrics and gynecological Nursing student |
| Affiliation |
College of Nursing, Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry |
| Address |
College of Nursing, Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7708533152 |
| Fax |
|
| Email |
kavithaperumal1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Niksy Abraham |
| Designation |
Tutor |
| Affiliation |
College of Nursing, Jawaharlal Institute of Post Graduate Medical Education and Research |
| Address |
Jawaharlal Institute of Post Graduate Medical Education and Research ,
College of Nursing,
Puducherry
605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8608553636 |
| Fax |
|
| Email |
renju.thms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Niksy Abraham |
| Designation |
Tutor |
| Affiliation |
College of Nursing, JIPMER |
| Address |
Jawaharlal Institute of Post Graduate Medical Education and Research, College of Nursing,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8608553636 |
| Fax |
|
| Email |
renju.thms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund ,Jawaharlal Institute of Post Graduate Medical Education and Research, College of Nursing,
Puducherry,
Gorimedu, Pondicherry 605006
|
|
|
Primary Sponsor
|
| Name |
Intra mural fund committee Jawaharlal Institute of Post Graduate Medical Education and Research |
| Address |
Intra mural fund committee,
Jawaharlal Institute of Post Graduate Medical Education and Research, College of Nursing,
Puducherry
605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mrs Niksy Abraham |
Jawaharlal Institute of Post Graduate Medical Education and Research |
Department of Obstetrics and gynecological Nursing, Antenatal Outpatient Department and Labor room, Ground floor, Women and child health block.
Pondicherry
PONDICHERRY |
8608553636
renju.thms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR NURSING COURSES(HUMAN STUDIES) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine antenatal care |
Primi gravida mothers with 36-37 weeks of gestation receive routine antenatal care during their antenatal visit and observe their intrapartum behavior during labor |
| Intervention |
Video assisted teaching regarding childbirth |
Primigravida mothers with 36-37 weeks of gestation receive intervention of first session of video assisted teaching on child birth for 15-20 minutes in antenatal OPD .One week later on seventh day the same second session of video on child birth will sent to whats app. If participant dont have mobile with whats app facility ,as per their regular subsequent antenatal visit day, the second session of video assisted teaching will be given at antenatal OPD. Once the participant admitted for delivery, their intrapartum behavior will be observe. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
PRIMI GRAVIDA MOTHERS WITH 36-37 WEEKS OF GESTATION
Primigravida mothers attending antenatal OPD. |
|
| ExclusionCriteria |
| Details |
Primigravida mother with bad obstetrical history. Primigravida mother who has absolute contraindication for vaginal delivery and who opted for epidural analgesia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of video assisted teaching regarding child birth between experimental and control group Difference in their intrapartum behavior among control and experimental group will assessed |
Primigravida mother of 36-37 weeks of gestation in control group receive routine antenatal care, while in the experimental group receive video assisted teaching .Approximately after 3-4 weeks or during delivery their intrapartum behavior will be assessed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2023 |
| Date of Study Completion (India) |
31/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study will helps to find out the effect of video assisted teaching regarding child birth on intrapartum behavior among primigravida mothers. According to this study the primigravida mothers with 36-37weeks of gestation in the experimental group receive video assisted teaching regarding childbirth and control group receive routine antenatal care and both the group’s intrapartum behavior being observed during their labor period |