| CTRI Number |
CTRI/2024/03/063938 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Pain reduction in laboring women
using VIRTUAL REALITY a non pharmacological approach in pain reduction |
|
Scientific Title of Study
|
efficacy of virtual reality vs tramadol in reduction of labor pain an intervention study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seepana manasa |
| Designation |
Junior resident |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
Department of Obstetrics and Gynecology
3rd floor opd building
AIIMS Mangalagiri,Guntur
Andrapradesh
AIIMS MANGALAGIRI
PG GIRLS HOSTEL
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9632587882 |
| Fax |
|
| Email |
manasaseepana961@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sairem Mangolnganbi Chanu |
| Designation |
Associate professor |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
Department of Obstertics and gynecology
3rd floor IPD building
AIIMS Mangalagiri
nil
ANDHRA PRADESH
522503
India |
| Phone |
8794713545 |
| Fax |
|
| Email |
dr.mangol123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Seepana manasa |
| Designation |
Junior resident |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
Department of Obstetrics and Gynecology
3rd floor IPD
AIIMS Mangalagiri
nil
ANDHRA PRADESH
522503
India |
| Phone |
9632587882 |
| Fax |
|
| Email |
manasaseepana961@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS mangalagiri |
| Address |
AIIMS managalagirir |
| 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 |
| Dr manasa |
AIIMS Mangalagiri |
Department of Obstertrics and Gynecology
3rd floor IPD
AIIMS Mangalagiri
Guntur
ANDHRA PRADESH |
9632587882
manasaseepana961@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS magalagiri IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
laboring women at term getsation
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Tramadol 50 mg im |
Injection tramadol in reduction of pain during laboring women |
| Intervention |
Virtual Reality |
Virtual reality
In reduction of pain in pregnant women during labor |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Nulliparus women at least 18 yrs of age having at leat 1 contraction every 5 minutes with pain score of 4 to 7 on numerical pain score |
|
| ExclusionCriteria |
| Details |
multiparity
not in term
less than one contraction in 5 mins
pain score more than 8 or less than 4
any contraindication to vr like preeclampsia , eclampsia history of epilepsy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain reduction through virtual reality i.e pain control through non pharmacological methods |
At the end of 30 mins
2hrs and 4hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vitals like pulse rate & blood pressure in lower limit |
2 yrs |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/03/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Child birth is considered as one of the most memorable and a painful experience in women’s life There are ground breaking advances in pain reduction and one of the noval method is using virtual reality . This is a noval trail by using virtual reality we try to decrease the pain perception and give a better pain control with minimal side effects compared to pharmacological methods
|