| CTRI Number |
CTRI/2025/09/095085 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Radiation Therapy
Preventive
Physiotherapy (Not Including YOGA)
Process of Care Changes
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Nurse-Led Strategies for Managing Episiotomy Pain and Promoting Healing: A Systematic Review. |
|
Scientific Title of Study
|
Effectiveness of Nurse led episiotomy care on episiotomy pain and healing among postnatal women at tertiary care hospital. |
| Trial Acronym |
NEC-CARE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priti Mishra |
| Designation |
Student |
| Affiliation |
King Georgs Medical University Lucknow UP |
| Address |
King George’s Medical University
Shah Mina Road, Chowk, Lucknow
Uttar Pradesh, India
King George’s Medical University
Shah Mina Road, Chowk, Lucknow
Uttar Pradesh, India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
09335923306 |
| Fax |
|
| Email |
mishrapreeti6612@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suman Lata |
| Designation |
Assistant Professor |
| Affiliation |
King Georgs Medical University Lucknow UP |
| Address |
KGMU College of Nursing Lucknow
KGMU college of Nursing Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9729764723 |
| Fax |
|
| Email |
sumanlatak@kgmcindia.edu |
|
Details of Contact Person
Public Query
|
| Name |
Priti Mishra |
| Designation |
Student |
| Affiliation |
King Georgs Medical University Lucknow UP |
| Address |
Kapasi Antu Pratapgarh
Kapasi Antu Pratapgarh
Pratapgarh
UTTAR PRADESH
230501
India |
| Phone |
09335923306 |
| Fax |
|
| Email |
mishrapreeti6612@gmail.com |
|
|
Source of Monetary or Material Support
|
| King George’s Medical University
Shah Mina Road, Chowk, Lucknow
Uttar Pradesh, India – 226003
KGMU College of Nursing, Queen Marys, Hospital Obstetrics and gynecological department, Postnatal ward |
|
|
Primary Sponsor
|
| Name |
Priti Mishra |
| Address |
King George’s Medical University
Shah Mina Road, Chowk, Lucknow
Uttar Pradesh, India – 226003 |
| Type of Sponsor |
Other [Self funding] |
|
|
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 |
| Priti Mishra |
Queen Mary Hospital , Obstetrics and gynecological department, Postnatal ward |
King George’s Medical University
Shah Mina Road, Chowk, Lucknow
Uttar Pradesh, India – 226003
Lucknow
UTTAR PRADESH |
09335923306
mishrapreeti6612@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee King george medical university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postnatal women with Episiotomy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse Led Episiotomy Care |
Total duration of intervention 30 min |
| Comparator Agent |
Standard Practice |
Routine care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Postpartum Women with episiotomy
Patients who will give written consent to participate in the study
No history of disease impaired wound healing |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
Diagnosed with Diabetes, Coagulation disorders, Puerperal sepsis etc.
Perineal tear grades 3 and 4
Having valvo vaginitis and hematoma or abscess in perineal |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
episiotomy pain score
episiotomy wound healing
compliance to self care practice for perineal care |
twice daily up to 3 day postpartum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
13/10/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Background Episiotomy is still widely practiced in many developing countries although recent evidence challenges its routine use Women who undergo this procedure often experience pain delayed wound healing and related complications Nurse led care has emerged as an important approach to provide structured support speed up recovery and promote self care among postnatal women Objectives This review aims to identify and categorize nurse led strategies for managing episiotomy assess their effectiveness in reducing pain and promoting wound healing evaluate outcomes using standard clinical tools and highlight the most effective interventions for postnatal recovery Methods A systematic search will be carried out in databases including MEDLINE PubMed CINAHL Psyc INFO CENTRAL and Scopus without restrictions on language or publication year Eligible studies will include nonrandomized designs focusing on women with episiotomy while studies involving women with conditions that impair wound healing will be excluded Interventions of interest include infrared therapy cold and hot compresses baths perineal hygiene nutrition and hydration education rest and positioning techniques Pain relief and wound healing will be the main outcomes measured with validated tools such as the Numeric Pain Rating Scale and the REEDA scale Secondary outcomes include wound complications use of pain medicines time to recovery daily functioning and satisfaction with care A narrative synthesis will be used to organize and present findings according to intervention type and outcomes Expected Results The review is expected to provide an evidence based summary of nurse led care approaches that improve pain management promote wound healing and support overall recovery after episiotomy Conclusions The findings will help strengthen nursing practices improve maternal health outcomes and guide the use of safe and effective non drug strategies in postnatal care Keywords Episiotomy Nurse led care Pain management wound healing Infrared therapy perineal care
|