| CTRI Number |
CTRI/2024/09/074149 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Benefits Of Oketani Breast Massage And Integrated Breast Massage In Relieving Pain, Reducing Engorgement And Improving Breastfeeding Self Efficacy In Postpartum Women With Breast Engorgement. |
|
Scientific Title of Study
|
Effect Of Oketani Massage And Integrated Breast Massage In Postpartum Women With Breast Engorgement: A Randomised Clinical 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 |
Srishti Nayak |
| Designation |
Postgraduate Student |
| Affiliation |
KLE Institute Of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, room no 39, Sagar floor KLE, Dr Prabhakar Kore Hospital and MRC Belgaum Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
7066718287 |
| Fax |
|
| Email |
srishti.nayak1011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Bulbuli |
| Designation |
Associate Professor |
| Affiliation |
KLE Institute Of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, room no 39, Sagar floor KLE, Dr Prabhakar Kore Hospital and MRC Belgaum Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9916043325 |
| Fax |
|
| Email |
ashwinichougala05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Bulbuli |
| Designation |
Associate Professor |
| Affiliation |
KLE Institute Of Physiotherapy |
| Address |
Advanced Physiotherapy Centre, room no 39, Sagar floor KLE, Dr Prabhakar Kore Hospital and MRC Belgaum Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9916043325 |
| Fax |
|
| Email |
ashwinichougala05@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs, DR. Prabhakar Hospital and Medical Research Centre, Belagavi, Karnataka, 590010 |
|
|
Primary Sponsor
|
| Name |
Srishti Nayak |
| Address |
Advanced physiotherapy centre, room no 39, sagar floor, Dr Prabhakar Kore Hospital and MRC, Belagavi, Karnataka, 590010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Ashwini Bulbuli |
KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre |
Advanced physiotherapy centre, room no 39, sagar floor, KLEs Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi, Karnataka, 590010
Belgaum
KARNATAKA |
9916043325
ashwinichougala05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O922||Other and unspecified disorders ofbreast associated with pregnancy and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Integrated Breast Massage |
Integrated breast massage, is a six steps breast massage will be given on engorged breast in postpartum women with day two postpartum for 3 consecutive days for about 30 mins. Before the application of massage moist heat pack will be applied for about 10 mins. The patient position will be supine lying and the therapist position will be besides the patient. |
| Intervention |
Oketani Massage |
Oketani massage, is an eight step breast massage which will be given on the engorged breast in postpartum women with day two postpartum for 3 consecutive days for about 20 mins. Before the application of massage moist heat pack will be applied on the breasts for about 10 mins. The patient position will be in supine lying and the therapist position will be besides the patient. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
women willing to participate
women with second day postpartum
postpartum women within the age group of 20-40 years
postpartum women having breast engorgement |
|
| ExclusionCriteria |
| Details |
pregnant women.
women who have undergone breast surgery and have breast implants.
women with chest infections.
women who have received any other treatment before the treatment session. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale (VAS)
Six point engorgement scale
Breastfeeding self efficacy scale short form (BSES-SF) |
Baseline and post 3 days intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/10/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
Modification(s)
|
The study aims to compare the effect of oketani massage and integrated breast massage in postpartum women with breast engorgement. Patients willing to participate will be screened and those fulfilling the inclusion and exclusion criteria will be recruited to the study. The purpose of the study will be explained and a written informed consent will be obtained from all the participants. Breast pain, breast engorgement and breastfeeding efficacy will be assessed pre and post intervention. Both the groups will receive moist heat for about 10 mins followed by respective treatment for 3 consecutive days. Pre and post intervention data will be recorded, tabulated and subjected to statistical analysis |