| CTRI Number |
CTRI/2022/09/045199 [Registered on: 05/09/2022] Trial Registered Prospectively |
| Last Modified On: |
26/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Bensons relaxation techniques ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Alternative therapy on blood pressure among pregnancy induced hypertensive mother |
|
Scientific Title of Study
|
Effectiveness of specific alternative therapy on blood pressure among antenatal mother with pregnancy induced hypertension in a selected Hospital of Bhubaneswar, Odisha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Sahoo |
| Designation |
M.Sc Nursing 2nd year student |
| Affiliation |
Kalinga institute of nursing sciences,KIIT Campus-5, Bhubaneswar 751024 |
| Address |
Kalinga institute of nursing sciences,KIMS Campus-5,KIIT, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
7978900480 |
| Fax |
|
| Email |
aishwaryasahoo201996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Kalyani Rath |
| Designation |
Professor, Department of Obstetrics and Gynecological nursing |
| Affiliation |
Kalinga Institute of Nursing Sciences, KIIT, Bhubaneswar |
| Address |
Kalinga Institute of Nursing Sciences KIIT Deemed to be University, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
7978117195 |
| Fax |
|
| Email |
rathkalyani78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Kalyani Rath |
| Designation |
Professor, Department of Obstetrics and Gynecological nursing |
| Affiliation |
Kalinga Institute of Nursing Sciences, KIIT, Bhubaneswar |
| Address |
Kalinga Institute of Nursing Sciences KIIT Deemed to be University, Bhubaneswar
ORISSA
751024
India |
| Phone |
7978117195 |
| Fax |
|
| Email |
rathkalyani78@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pradyumna bal memorial Hospital Kalinga Institute of Medical Sciences KIIT DU Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
Aishwarya Sahoo |
| Address |
Kalinga institute of nursing sciences KIMS Campus-5 KIIT Bhubaneswar Odisha |
| Type of Sponsor |
Other [Self funded ] |
|
|
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 |
| Aishwarya Sahoo |
KALINGA INSTITUTE OF MEDICAL SCIENCES(KIMS) |
Antenatal ward, Ground floor, Department of Obstetrics and Gynecology Building, Pradyumna Bal Memorial Hospital KIIT DEEMED TO BE UNIVERSITY CAMPUS 5 PATIA BHUBANESWAR 751024
Khordha
ORISSA |
7978900480
aishwaryasahoo201996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bensons Relaxation Therapy |
Antenatal Mother position them comfortably with closed eyes.Keeping their muscles relaxed,they breath in through their nose and exhale through mouth.
while breathing out they say one and continue to breath naturaly.They continue these practice for 15 to 20 mins |
| Comparator Agent |
Routine medication |
Control group will receive routine medication for Pregnancy induced hypertension.there will be no intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Antenatal mother diagnosed with Pregnancy induced hypertension
Antenatal mother admitted in hospital during my study period
Antenatal mother who has given consent for participating in study
Antenatal mother who can understand Odia and English |
|
| ExclusionCriteria |
| Details |
Antenatal mother having blood pressure more than 160/100mmHg
Antenatal mother having high risk pregnancy other than Pregnancy induced hypertension
Non compliance to deep breathing excercises |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood pressure of antenatal mother with pregnancy induced hypertension will be decreased after after receiving intervention |
3month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| After intervention blood pressure of antenatal mother with pregnancy induced hypertension will be on normal range |
6month |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
09/09/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized control trial to check the effectiveness of specific alternative therapy that is Benson relaxation techniques will be given to antenatal mother diagnosed with Pregnancy induced hypertension to reduce blood pressure in a selected Hospital. Blood pressure will be measured before and after giving intervention and will be compared for effectiveness of the therapy |