| CTRI Number |
CTRI/2026/02/102730 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
relaxation technique for postpartum depression |
|
Scientific Title of Study
|
Bensons relaxation technique versus jacobsos relaxation technique on postpartum depression |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandhiya S |
| Designation |
postgraduate student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
No.1 Ramachandra Nager,
Sri Ramachandra Faculty Of Physiotherapy,
Porur, Chennai,
Tamilnadu.
600116 No.1 Ramachandra Nager,
Sri Ramachandra Faculty Of Physiotherapy,
Porur, Chennai,
Tamilnadu.
600116 Chennai TAMIL NADU 603306 India |
| Phone |
9500966034 |
| Fax |
|
| Email |
drop2sandhiya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
MsPPonmathi |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
No.1 Ramachandra Nager,
Sri Ramachandra Faculty Of Physiotherapy,
Porur, Chennai.
600116 No.1 Ramachandra Nager,
Sri Ramachandra Faculty Of Physiotherapy,
Porur, Chennai.
600116 Chennai TAMIL NADU 600116 India |
| Phone |
9787211229 |
| Fax |
|
| Email |
ponmathi.p@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
MsPPonmathi |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
No.1 Ramachandra Nager,
Sri Ramachandra Faculty Of Physiotherapy,
Porur, Chennai.
600116 No.1 Ramachandra Nager,
Sri Ramachandra Faculty Of Physiotherapy,
Porur, Chennai.
600116 Chennai TAMIL NADU 600116 India |
| Phone |
9787211229 |
| Fax |
|
| Email |
ponmathi.p@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sandhiya
name of the institution: Sri Ramachandra institute of higher education and research
Hospital: SRIHER G-Block
|
|
|
Primary Sponsor
|
| Name |
Sandhiya.S |
| Address |
No.1 Ramachandra nager,
Porur, Chennai,
600116 |
| 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 |
| MsPPonmathi |
Sri Ramachandra Hospital |
No.1, G-Block,
Sri Ramachandra hospital,
Sri Ramachandra Nager,
Porur, Chennai
Chennai TAMIL NADU |
9787211229
ponmathi.p@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postpartum Depression |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jacobsons Relaxation Technique And
Bensons Relaxation Technique |
Jacobsons Relaxation Technique And
Bensons Relaxation Technique for postpartum depression womens for 4-weeks |
| Comparator Agent |
Jacobsons Relaxation Technique and
Bensons Relaxation technique |
Jacobsons Relaxation Technique and
Bensons Relaxation technique for postpartum depression for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Postnatal women aged 18 to 40 years.
2. Women who are 2 to 12 weeks postpartum.
3. Women with mild to moderate postpartum depression as per the outcome measures
4. Willing to participate and provide informed consent.
5. Able to understand and follow instructions for relaxation techniques.
|
|
| ExclusionCriteria |
| Details |
1. Women with severe postpartum depression requiring immediate psychiatric intervention.
2. Women with a history of major psychiatric disorders
3. Women currently undergoing pharmacological treatment for depression.
4. Presence of any medical or obstetric complications
5. Women with hearing, cognitive, or language impairments that hinder participation.
6. Participation in other relaxation or psychotherapy programs during the study period.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Edinburgh postnatal depression scale (EPDS)
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| world health organisation quality of life (WHOQOF) |
6MONTHS |
|
|
Target Sample Size
|
Total Sample Size="270" Sample Size from India="270"
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)
|
12/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="15" |
|
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
|
|