| CTRI Number |
CTRI/2024/05/066854 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Benson’s vs Mitchell’s relaxation as adjunct to medications on vitals , anxiety and quality of life on women with pre-eclampsia |
|
Scientific Title of Study
|
Effect of Benson’s Relaxation vs Mitchell’s Relaxation Along With Conventional Physiotherapy Exercise as an Adjunct to Medications to Improve Vitals, Anxiety, and Quality of Life in Preeclampsia: A Comparative 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 |
Dr Gauri Kariya |
| Designation |
Junior Resident |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9370582918 |
| Fax |
|
| Email |
kariyagauri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Lashkari |
| Designation |
Associate Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422865300 |
| Fax |
|
| Email |
drravilashkari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravi Lashkari |
| Designation |
Associate Professor |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, wardha
MAHARASHTRA
442001
India |
| Phone |
9422865300 |
| Fax |
|
| Email |
drravilashkari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha-442001. |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha-442001. |
| 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 Gauri Kariya |
Acharya Vinoba Bhave Rural Hospital (AVBRH), Ravi Nair Physiotherapy College, |
Department of Gynecology , In Patient Department Ante-natal ward ,AVBRH, Datta Meghe Institute of Higher Education and Research , Ravi Nair Physiotherapy College Sawangi Meghe, Wardha
Wardha
MAHARASHTRA |
9370582918
kariyagauri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research(DU), Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bensons Relaxation |
On Identifying pre-eclampsia patients Benson’s relaxation will be given for duration of 30 minutes. It comprises five parts: 1) a quiet atmosphere: selecting a location that is free of distractions; 2) adopting a relaxing posture, such as seated, standing, sleeping, or walking, is essential; 3) suitable acceptance: relaxing all the muscles commencing from the soles of the feet up to the facial muscles, ensuring that everything is relaxed; 4) concentration: concentration and staying oriented to the breathing patterns and inspiring through the nose, with expiration through the mouth; 5) suitable acceptance: maintaining relaxed attitude. The methods act by lowering the sympathetic nervous systems activity and reducing the levels of endogenous catecholamine. This Relaxation will be given for 8 weeks |
| Comparator Agent |
Mitchells Relaxation |
Subjects will receive 30 min Mitchell’s relaxation exercise per day along with Conventional Physiotherapy Exercises in both the groups. Conventional Physiotherapy Exercises include: respiratory (diaphragmatic breathing), flexion, extension and lateral rotation of the head, circumduction of the shoulders forward and back, flexion and extension of the elbows and wrists, and opening and closing the hands. Dorsiflexion exercises, plantar flexion, circular movements of the ankles, internal and external rotation of the coxofemoral joint, flexion and extension of the knees while sliding on the bed. Follow up of the patient will be done on the daily basis.Mitchells physiological relaxation method incorporates diaphragmatic breathing exercises and a sequence of serial isotonic contractions focused on reciprocal inhibition. This will given for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
a) Age from 18 years to 45 years of age
b) B.P more than 140 mmHg
c) Counselling done by psychologist pre and post treatment
d) Low scores on beck anxiety inventory questionnaire
e) Subjects receiving standard Doses of anti-Hypertensives. |
|
| ExclusionCriteria |
| Details |
Immuno-compromised conditions such as AIDS.
Neurological Impairments.
Cognitive Impairments.
Musculoskeletal, Neurological or any cardio-respiratory complications.
Subjects on Anti-Anxiety Drugs. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Health Related Quality of life Scale
Beck Anxiety Inventory
Digital Sphygmomanometer |
Health Related Quality of life Scale
Beck Anxiety Inventory
Digital Sphygmomanometer
All these will be taken 4 weeks after the intervention except Digital sphygmomanometer will be used daily to asses B.P |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
22/05/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The
aim of the study is to give conventional physiotherapy exercises in both the
groups and along with that Benson’s and Mitchell’s Relaxation and to evaluate
with the help of outcomes which group has better improvement. |